This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.

Start Date14 Feb 2027

Sponsor / Collaborator

National Cancer Institute

NCT07423611

/ Not yet recruitingPhase 2IIT

A Multicenter, Open-label, Randomized Controlled Clinical Study Comparing the Efficacy and Safety of ctDNA-guided Ribociclib Plus Endocrine Therapy Versus Chemotherapy Followed by Ribociclib Plus Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Start Date01 Oct 2026

Sponsor / Collaborator

Fudan University

NCT07618390

/ Not yet recruitingPhase 2IIT

A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative (HER2-), endocrine-resistant metastatic breast cancer (mBC). Approximately 160 patients will be enrolled at around 16 centers in China.
The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.
PIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of the treatment regimen are provided in the Study Treatment section. Study treatment will continue until radiologically confirmed disease progression as determined by the investigator, unacceptable toxicity, withdrawal of informed consent, or study termination, whichever occurs first.
Patients must have measurable disease according to RECIST v1.1. Patients with bone-only metastases are not eligible, even if the lesions are considered measurable. Locally advanced disease must be unsuitable for surgical resection or other local treatment with curative intent.

Start Date01 Jun 2026

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

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100 Clinical Results associated with Ribociclib Succinate

100 Translational Medicine associated with Ribociclib Succinate

100 Patents (Medical) associated with Ribociclib Succinate

1,345

Literatures (Medical) associated with Ribociclib Succinate

31 Dec 2026·Journal of Pharmaceutical Policy and Practice

Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis

Article

Author: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen

Background:

Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods:

We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results:

Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion:

Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

01 Sep 2026·Biomaterials advances

Ribociclib-loaded folic acid conjugated chitosan-polycaprolactone hybrid nanoparticles for the management of glioblastoma

Article

Author: Mehra, Neelesh K ; Rajana, Naveen ; Mehta, Dhwani ; Quadros, Mural ; Islam, Md Asrarul ; Mokashi, Meghana ; Sanhueza Chavez, Carlos A ; Kumar, Sunil ; Gupta, Vivek ; Alkyam, Mayssam ; Ravula, Sravani ; Perron, Jeanette C

The objective of the present research investigation is to assess the anti-glioblastoma potential of Ribociclib (Ribo) and Ribociclib-loaded folic acid conjugated chitosan-polycaprolactone nanoparticles (RFCPNPs). Folic acid was conjugated to glycol chitosan by carbodiimide chemistry, and the formation of the conjugation was confirmed by FT-IR and ¹H NMR. RFCPNPs were fabricated by the single emulsification method, and particle size, PDI, surface charge, %EE, and % DL were 127.8 ± 4.37 nm, 0.197 ± 0.012, 5.05 ± 0.1 mV, 70.82 ± 4.25%, and 3.37 ± 0.20%, respectively. The presence of pH-sensitive biological macromolecule, i.e., chitosan, in the carrier system provides pH-sensitivity to RFCPNPs and displays diffusion-controlled release of the Ribo up to 48 h. RFCPNPs exhibited a bi-phasic release pattern, releasing approximately 22.9 ± 3.8%, 23.2 ± 5.8%, and 7.3 ± 1.2% of Ribo within 1 h, and 98.3 ± 1.6%, 86.6 ± 1.5%, and 75.8 ± 5.1% of Ribo were released from RFCPNPs in 48 h in pH 5.5, 6.8, and 7.4 dissolution media, respectively. The half-maximal inhibitory concentration (IC₅₀) of RFCPNPs was found to be 2.7 ± 0.3 and 3.2 ± 0.10 μM in U87 MG and U138 MG cells, which is 8-10-fold-, and 2-3-fold less than the pure Ribo and unconjugated nanoparticles, respectively. The receptor blocking assay demonstrated the significant role of folic acid in the anti-glioblastoma efficacy of the RFCPNPs. RFCPNPs exhibited enhanced ROS generation, apoptosis, and reduced mitochondrial membrane potential of U87 MG cells compared to the pure Ribo. RFCPNPs exhibited approximately 40% apoptotic cells, more than 1.6 times greater than those of the plain drug counterpart. The Ribo and RFCPNPs exhibited 27.1 ± 2.2%, 66.2 ± 1.3% cellular migration inhibition, and 380 ± 46 and 10 ± 4 colonies, respectively. U87 MG spheroids treated with Ribo and RFCPNPs demonstrated 64.3 ± 5.2% and 34.7 ± 11.0% viable cells, respectively. These outcomes suggest that the optimized nanocarrier represents a promising approach for treating glioblastoma.

01 Jul 2026·INTERNATIONAL JOURNAL OF CARDIOLOGY

Incidence and outcomes of atrial arrhythmia with cyclin dependent kinase 4/6 inhibitors in hormone receptor-positive / human epidermal growth factor receptor 2-negative breast cancer

Article

Author: Hodge, David O ; Herrmann, Joerg ; Davis, Nathaniel E ; Ruddy, Kathryn J ; Tan, Nicholas Y ; Blumenfeld, Sophia

BACKGROUND:

Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are increasingly used in hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer, yet emerging data suggest potential cardiotoxicity, including atrial arrhythmias (AA). Understanding incidence and outcomes of AA is essential as indications for CDK4/6 inhibitors expand.

OBJECTIVES:

To evaluate the incidence of new-onset AA and associated outcomes in patients with HR+/HER2- breast cancer treated with CDK4/6 inhibitors.

METHODS:

We conducted a retrospective cohort study of patients who received CDK4/6 inhibitors for HR+/HER2- breast cancer at Mayo Clinic from 2015 to 2024. The primary outcome was incidence of AA (atrial fibrillation, atrial flutter, or atrial tachycardia). Secondary outcomes included cerebrovascular events and all-cause mortality. Fine-Gray subdistribution hazard models and Cox regression models were used to assess risk factors for AA and all-cause mortality, respectively.

RESULTS:

Among 2773 patients, 59% received palbociclib, 28% abemaciclib, and 14% ribociclib. New-onset AA occurred in 42, cumulative incidence at 5 years of 2.1% (95% CI 1.5-2.8%). No significant differences in 5-year AA incidence were observed between agents: 1.5% (95% CI 0.7-2.8%), 2.3 (95% CI 1.6-3.2%), 1.0 (95% CI 0.3-2.6%) (p = 0.49). Multivariable analysis identified age at treatment as the only independent predictor of AA (HR 1.07, 95% CI 1.04-1.09, p < 0.001). New-onset AA was associated with increased mortality (HR 1.56, 95% CI 1.10-2.20, p = 0.012).

CONCLUSIONS:

Patients who receive CDK4/6 inhibitors for breast cancer experience a low but measurable risk of new-onset atrial arrhythmias. There was no significant difference in new-onset AA risk between agents. Prospective studies are needed to define mechanisms and guide monitoring strategies.

460

News (Medical) associated with Ribociclib Succinate

02 Jun 2026

·www.fiercepharma.com

ASCO: Roche, head held high, details oral SERD's first-line flop in breast cancer

A glimmer of hope in Roche's failed persevERA trial has given the Swiss pharma confidence in launching a new phase 3 study of its giredestrant in combination with CDK4/6 inhibitor in early breast cancer. To Roche, a phase 3 flop in first-line breast cancer does not erase the megablockbuster potential of its oral SERD drug giredestrant even as competition mounts.In fact, results from the failed persevERA trial in first-line HR-positive, HER2-negative metastatic breast cancer have given Roche confidence in a new study that will test the combination of giredestrant with a CDK4/6 inhibitor for the adjuvant treatment of early-stage breast cancer, Roche’s deputy chief medical officer, Stefan Frings, M.D., Ph.D., told Fierce in an interview. “What we still see is a quite attractive separation of the curve […] You will clearly see there’s a treatment effect,” Frings said of progression-free survival (PFS) data from persevERA. “This convinces us, because in the adjuvant setting, we treat for five years, and if we move a few percentage points upwards, you would have already a positive treatment effect in the adjuvant setting.”Frings wouldn’t disclose any details of the upcoming new adjuvant study, saying it’s still in the design phase. Before the persevERA result, Roche already reported a positive readout from the lidERA trial of giredestrant monotherapy in the adjuvant setting. The surprise first-line flopAfter the lidERA hit in November, the persevERA miss came as a big surprise. According to results presented at the American Society of Clinical Oncology 2026 annual meeting, the combination of giredestrant and Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) showed a numerical 11% PFS improvement by investigator analysis compared with Novartis’ aromatase inhibitor Femara (letrozole) and Ibrance, failing to meet statistical significance.The giredestrant regimen’s 33.1-month median PFS was 4.9 months longer than that of the control arm. Because metastatic patients are treated until disease progression, half of them will receive giredestrant for less than three years, or just about half of the five-year duration intended for early-stage therapy.The PFS curve separation that Frings discussed started to emerge around 16 months. At two years, 59.7% of patients in the giredestrant arm and 57.3% in the control group remained progression-free. By three years, the PFS rates were 45.8% and 41.9%, respectively. In contrast, giredestrant struggled to show any overall survival advantage, as the hazard ratio logged at 1.03, meaning death risk was marginally higher for the Roche drug, although the data were immature with a median follow-up of about 52 months. Three-year OS rates were the same at 74.1% for the two arms, and median OS was not reached in either arm. “The reason why this may not have worked is that certainly CDK4/6 [inhibitors] are very potent agents,” Frings said, “and that you don’t see early on what is really an effect of an endocrine manipulation. A dead cell is dead, and you can’t kill it better when it’s already dead.”On the safety side, adverse events (AEs) were generally comparable between the two treatment groups but were more frequent for giredestrant. Serious AEs were recorded in 23.9% of giredestrant patients, versus 18.8% in the control arm. Treatment-related adverse events led to one (0.2%) death and two (0.4%) deaths between the groups, respectively. Roche has a second first-line study, pionERA, which is testing giredestrant alongside CDK4/6 inhibitor in a more endocrine-resistant population. Patients enrolled in that study would have relapsed on adjuvant endocrine therapy or have had a treatment-free interval of less than a year. Frings said Roche is far more confident in this trial because most of these patients bear ESR1 mutations, for whom oral SERDs are known to work better.Roche’s first FDA application for giredestrant, bearing a target decision date of Dec. 18, 2026, is in second-line, ESR1-mutated HR+/HER2- breast cancer. The limited pursuit of the ESR1 subgroup was somewhat expected, mirroring past oral SERD approvals; but it was still disappointing given how Roche had touted a benefit in a broad, all-comers population. “We knew that an [intent-to-treat label] would be an uphill battle, therefore we filed on purpose in ESR1-mutant [patients],” Frings said. But Roche “would leave the door open, depending on the evolution of the data,” to potentially seek a broader label regardless of ESR1 status, especially if more mature OS data are strong, he added. Eyes on the prizeThe FDA has accepted giredestrant for HR+ early-stage breast cancer, Roche announced Monday. After the company spent a priority review voucher, the FDA has set a target decision date of Nov. 30.At ASCO 2026, a subgroup analysis of the lidERA trial showed the benefit of adjuvant giredestrant regardless of a patient’s menopausal status. Compared with standard endocrine therapy, giredestrant improved invasive disease-free survival (iDFS) by 35% in pre-menopausal women and by 26% in post-menopausal patients. During the investor call in April, Roche Pharmaceuticals CEO Teresa Graham defended giredestrant’s potential—with a peak sales forecast “well north of” 3 billion Swiss francs—despite the first-line persevERA setback. That’s because the adjuvant setting is a much larger market “with three times more drug-treated patients than in first-line metastatic and a much longer treatment duration [of] around five years,” she said. However, critics have pointed out that the lidERA trial does not answer how giredestrant fares either against or in combination with CDK4/6 inhibitors, which has recently become a standard treatment for certain patients with early-stage HR+/HER2- breast cancer. By a cross-trial comparison, giredestrant’s 30% iDFS improvement was comparable to the CDK4/6 drugs, although the trial populations were different. While Verzenio’s and Kisqali’s adjuvant uses—which require combination with endocrine therapy—cover patients at high risk of recurrence, single-agent giredestrant may be an attractive option for low- and medium-risk patients, Frings said.For patients who want to maximize efficacy, giredestrant could be the best backbone for a combination because it’s the more potent oral SERD, Frings argued. For now, Roche is conducting a 100-patient substudy in lidERA, evaluating the safety of giredestrant in combination with Eli Lilly’s CDK4/6 drug Verzenio in the adjuvant setting. It also recently started a separate 200-patient study evaluating the safety of giredestrant with Novartis’ Kisqali. Other companies, including Lilly, AstraZeneca and Menarini, are conducting phase 3 trials to test their oral SERDs in patients who have already received a few years of adjuvant therapy, including a CDK4/6 drug.Frings argued that this trial design is “convoluted” and “more like a 2-by-2 design” because not all patients will be exposed to a CDK4/6 inhibitor. Besides, while lidERA showed a treatment effect for the oral SERD early on, that opportunity of early intervention is gone in the competitor design, the Roche exec said. Because those trials’ participants would have previously received two to five years of adjuvant therapy, adherence may be a challenge for continued treatment, too, he added. As for Roche’s upcoming adjuvant trial, “we must just design it well, get buy-in from authorities,” Frings said. “And then, once we are able to talk about it, we will announce what precisely we will do.”

Phase 3Clinical ResultASCOPriority ReviewDrug Approval

02 Jun 2026

·www.businesswire.com

Camizestrant Combination Delayed Time to First Progression by 55% and to Second Progression by 37% in Patients With Advanced HR-positive Breast Cancer With an Emergent ESR1 Tumor Mutation in SERENA-6 Trial

WILMINGTON, Del.--(BUSINESS WIRE)--Further positive results from the Phase III SERENA-6 trial showed AstraZeneca's camizestrant plus a cyclin-dependent kinase (CDK) 4/6 inhibitor – palbociclib, ribociclib or abemaciclib – maintained its progression-free survival (PFS) benefit with longer follow-up and delivered a statistically significant and clinically meaningful improvement in second progression-free survival (PFS2), demonstrating sustained benefit beyond initial treatment. Additionally, exploratory analyses showed that the camizestrant combination profoundly reduced total circulating tumor DNA (ctDNA) and enabled substantially more patients to achieve total ctDNA clearance. The trial evaluated switching to the camizestrant combination before progression in the 1st-line setting versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor following detection of an ESR1 mutation in patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer. SERENA-6 met its primary endpoint of PFS at the interim analysis, with results first presented at last year’s American Society of Clinical Oncology (ASCO) and simultaneously published in The New England Journal of Medicine.1 The updated results will be presented today during the 2026 ASCO Annual Meeting in Chicago, IL (abstract LBA1007). The updated results showed the camizestrant combination reduced the risk of disease progression or death by 55% versus an AI plus a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.45; 95% confidence interval [CI] 0.34-0.59; p<0.00001). Median PFS was 16.8 months for the camizestrant combination compared with 9.2 months for the AI combination, representing a median improvement of 7.6 months. Importantly, the PFS benefit observed with the camizestrant combination was sustained beyond initial progression. For the key secondary endpoint of PFS2, a measure of treatment durability beyond first progression, the final PFS2 analysis showed that the camizestrant combination reduced the risk of second disease progression or death by 37% versus the comparator arm (HR 0.63; 95% CI 0.46-0.86; p=0.00373), indicating that the benefit of switching to camizestrant plus a CDK4/6 inhibitor was maintained even after patients received subsequent therapies. Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination. The camizestrant combination also demonstrated substantially greater reductions in total ctDNA in blood than continued treatment with an AI plus a CDK4/6 inhibitor at week 4 and/or week 8 after randomization. Patients who switched to the camizestrant combination had a median 99% reduction in total ctDNA by week 8, with 51% achieving total ctDNA clearance, compared with a median 64% increase in total ctDNA by week 8, and 1.9% total ctDNA clearance among patients who remained on the AI combination. These results show the early effect of switching to camizestrant on ctDNA which is linked to tumor burden reduction. Clearance of total ctDNA during treatment has been associated with long-term clinical benefit including improved overall survival (OS) across tumor types, including in patients with HR-positive, HER2-negative advanced breast cancer receiving endocrine-based therapy plus a CDK4/6 inhibitor.2,3 In an exploratory analysis pooled across both arms in SERENA-6, total ctDNA clearance was associated with OS benefit (HR 0.39; 95% CI 0.19-0.73), consistent with other studies. Data for the key secondary endpoint of OS showed a numerical trend favoring the camizestrant combination (HR 0.87; CI 0.57-1.30) at 30% maturity. The trial will continue to final analysis to assess OS. François-Clément Bidard MD, PhD, Professor of Medical Oncology at Institut Curie & Versailles University (Paris/Saclay) France and co-principal investigator for the trial, said: “Optimizing outcomes for patients with HR-positive advanced breast cancer early in their treatment is critical because once the disease progresses, it becomes harder to treat and outcomes worsen. The updated SERENA-6 results support the paradigm of switching to a camizestrant-based combination in the first-line setting upon emergence of an ESR1 mutation and demonstrate durable improvements beyond initial treatment. These results should change how we approach treating patients with HR-positive disease in the first-line setting.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “More than half of patients who switched to the camizestrant combination completely cleared tumor DNA from their bloodstream compared to two percent with standard of care. This provides robust evidence that an early treatment switch has strong anti-tumor efficacy, and supports the potential for long-term clinical benefit. Switching to the camizestrant combination also extended the time patients lived without disease progression after first- and second-line treatment, delayed the need for more intensive therapies, and helped patients maintain their quality of life. Together, these results add to the growing data supporting the potential of the camizestrant combination to improve outcomes for these patients with advanced breast cancer.” Summary of results: SERENA-6 at ASCO 2026 Camizestrant + CDK4/6 inhibitor AI + CDK4/6 inhibitor PFSi Number of patients (n) 157 158 Median PFS (months) 16.8 (14.7-19.4) 9.2 (7.2-9.7) 24-month PFS rate 34.9% 14.2% Hazard ratio (95% CI) 0.45 (0.34-0.59) p-value p<0.00001 PFS2ii Number of patients (n) 157 158 Median PFS2 (months) 25.7 (20.4-30.3) 19.1 (16.8-21.0) 24-month PFS2 rate 50.8% 36.3% Hazard ratio (95% CI) 0.63 (0.46-0.86) p-value p=0.00373 OSiii Events, n (%) 46 (29.3) 49 (31.0) Hazard ratio (95% CI) 0.87 (0.57-1.30) Change in total ctDNA Median change from baseline at week 8 -99% +64% Total ctDNA clearanceiv Number of patients with clearance/total analyzed 50/98 2/108 Patients with total ctDNA clearance (%) 51.0 1.9 CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; PFS2, progression-free survival 2; OS, overall survival Additional analyses showed that the camizestrant combination delayed the need for more intensive subsequent treatment, including chemotherapy or antibody-drug conjugates (ADCs). Median chemotherapy/ADC-free survival was 22.6 months for the camizestrant combination versus 18.7 months for the AI combination (HR 0.64; 95% CI 0.47-0.87; p=0.00375). The camizestrant combination was also associated with delayed deterioration in patient-reported cancer symptoms such as pain, global health status and quality of life. The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified, and discontinuations were very low and similar in both arms. Camizestrant is approved in the United Arab Emirates and Saudi Arabia based on the SERENA-6 trial. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently adopted a positive opinion recommending approval of the camizestrant combination in the European Union based on the results of the SERENA-6 Phase III trial. Regulatory applications are also currently under review in the US, Japan and several other countries. The US Food and Drug Administration last week extended the Prescription Drug User Free Act date to review the updated results from the SERENA-6 trial. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.4 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.4 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.5 HR-positive breast cancer, characterized by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumors considered HR-positive and HER2-negative.5 More than 97% of HR-positive breast cancer tumors are estrogen receptor (ER)-positive. ERs often drive the growth of HR-positive breast cancer cells.6 Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.7-9 However, resistance to these therapies develops in many patients.9 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.5,9 Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.10,11 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.7 The optimization of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. SERENA-6 SERENA-6 is a Phase III, double-blind, randomized trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumors have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. SERENA-6 is the first global, registrational Phase III trial to use a circulating tumor DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumor scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. Camizestrant Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer. AstraZeneca’s broad, robust and innovative clinical development program, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer. Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus fulvestrant in the overall trial population, including in patients with ESR1 tumor mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumor profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment. With fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines fulvestrant and goserelin and aims to reshape the HR-positive space with first-in-class AKT inhibitor, capivasertib, the TROP-2-directed ADC, datopotamab deruxtecan-dlnk and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor olaparib is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with Merck & Co., Inc., known as MSD outside the US and Canada, continue to research olaparib in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of datopotamab deruxtecan-dlnk alone and in combination with immunotherapy durvalumab. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Bidard FC, et al. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer. N Engl J Med 2025; DOI: 10.1056/NEJMoa2502929. Chia SKL, et al. On-treatment (tx) dynamic circulating tumor DNA changes (∆ctDNA) associated with progression-free survival (PFS) and overall survival (OS) of patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA-3 (ML-3). J Clin Oncol 2024;42(16_suppl):1012. Fuentes-Antrás J, et al. Personalized ctDNA monitoring in metastatic HR+/HER2− breast cancer patients during endocrine and CDK4/6 inhibitor therapy. npj breast cancer 2025;11:74. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin . 2024; 1- 35. DOI:10.3322/caac.21834. National Cancer Institute. Cancer Stat facts: Female breast cancer subtypes. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html . Accessed June 2026. Scabia V, et al. Estrogen receptor positive breast cancers have patient specific hormone sensitivities and rely on progesterone receptor. Nat Commun . 2022; 10.1038/s41467-022-30898-0. Cerner CancerMPact database. Accessed June 2026. Lin M, et al. Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer. J Cancer . 2020; 10.7150/jca.48944. Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor–positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res . 2022; 28(5):821-30. Brett O, et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor‑positive breast cancer. Breast Cancer Res . 2021; 23:85. Zundelevich A, et al. ESR1 mutations are frequent in newly diagnosed metastatic and loco-regional recurrence of endocrine-treated breast cancer and carry worse prognosis. Breast Cancer Res . 2020; 22:16. US-113305

01 Jun 2026

·www.einpresswire.com

Sciensus & One Heart Clinic launch home-based ECG service for private cancer patients funded by private medical insurers

New partnership expands access to cardiac monitoring, enabling more patients to receive cancer treatment at home LONDON, UNITED KINGDOM, June 1, 2026 / EINPresswire.com / -- Sciensus , one of the UK’s largest private provider of systemic anticancer treatment at home (SACT), and One Heart Clinic , a cardiac specialty group comprised of world-class cardiologists from leading teaching hospitals across the UK, today announced a new partnership to deliver a home-based ECG service for private cancer patients, improving access to this critical diagnostic tool and enabling more patients to receive cancer treatment at home. The national service will launch in phases across selected regions in the UK, allowing patients to undergo ECG testing at home and avoid additional hospital visits during treatment and giving consultants access to nationwide cardiologist support via the One Heart Clinic. By embedding cardiac monitoring and support into a nurse-led homecare pathway, the service is designed to support informed treatment decisions and access to therapies that require routine ECG assessment as part of treatment initiation and continuation. The service is particularly relevant for patients receiving therapies, including newer cancer treatments such as those used in breast cancer, where ECG monitoring is required. Delivered as an extension of Sciensus’ established cancer care model, ECGs will be captured in the home by specialist cancer nurses using a small, non-invasive portable device and securely transmitted to One Heart Clinic for specialist interpretation. Consultant cardiology reports will be returned within 24 hours and shared with treating cancer consultants via Sciensus’ digital systems, enabling rapid escalation if any concerns are identified. Mark Hawken, Managing Director, Cancer Services at Sciensus, said: "This partnership strengthens our integrated model of cancer care closer to home. By combining specialist nursing support with timely access to ECG testing, we are enhancing patient protection and supporting access to a wider range of cancer treatments, like Ribociclib for breast cancer patients, that can be delivered in the home.” By bringing this capability into the home, Sciensus is helping remove a key barrier to treatment outside the hospital setting—supporting faster clinical decision-making, earlier detection of potential cardiac issues and enabling more patients to benefit from home-based care. Dr Sherif Raouf, Clinical Director of Cancer at Sciensus, said: “Cancer care should reflect the needs of the whole patient. By reducing the practical and emotional burden associated with hospital visits, while also enabling access to treatments that require closer monitoring, we are creating a more personalised and manageable care experience without compromising clinical quality.” Evidence from emerging digital home-based cancer care models suggests that remote monitoring, including home ECG and other safety checks, can detect treatment-related risks earlier, reduce unnecessary hospital visits and support better quality of life and survival through fewer treatment interruptions. This aligns with Sciensus’ approach, where specialist nurses and digital tools work together to improve adherence, persistence and overall health outcomes for patients treated at home. Dr Ravi Assomull, Consultant Cardiologist at One Heart Clinic, said: “Timely access to ECG assessment is essential for many cancer patients, particularly as newer therapies increasingly require cardiac monitoring. This partnership enables rapid, specialist interpretation through a clinically robust and patient-centred pathway, ensuring cancer teams have the information they need to support treatment decisions.” The ECG service supports Sciensus’ broader ambition to expand access to innovative treatments and supportive services through a proven homecare infrastructure, including medicine delivery, remote monitoring and digital care pathways. The collaboration also provides consultants with streamlined access to nationwide cardiology expertise via One Heart Clinic, supporting more connected, flexible and scalable cancer care delivery. About Sciensus Private Cancer Services Sciensus is redefining private cancer care as one of the UK’s largest private providers of SACT with nationwide coverage, delivering a comprehensive, end-to-end service that enables personalised, hospital-quality treatment at home. The model combines highly skilled integrated clinical teams made up of dedicated SACT nurses, specialty pharmacists and clinical nurse specialists with advanced compounding and a nationwide delivery infrastructure. Supported by digital tools that ensure safe, efficient and fully visible care pathways, patients and consultants also have access to a 24-hour support programme. About One Heart Clinic One Heart Clinic is a UK cardiac centre of excellence, bringing together leading cardiologists to deliver expert heart care and advanced non-invasive diagnostics through a nationwide network, with flagship sites on Harley Street and in the City of London. Please find more information at: https://www.oneheartclinic.com/ Media contacts Sciensus: Julie Reid marketing@sciensus.com One Heart Clinic: enquiries@oneheartclinic.com Julie Reid Sciensus email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

AHA

100 Deals associated with Ribociclib Succinate

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KEGG	Wiki	ATC	Drug Bank
-	Ribociclib Succinate	L01XE	DB11730

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Advanced breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	02 Mar 2018
Metastatic breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	02 Mar 2018
Hormone receptor positive HER2 negative breast cancer	United States	Novartis Pharmaceuticals Corp.	13 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced HER2-Positive Breast Carcinoma	Phase 3	United States	Novartis AG	28 Mar 2022
Advanced HER2-Positive Breast Carcinoma	Phase 3	Portugal	Novartis AG	28 Mar 2022
Advanced HER2-Positive Breast Carcinoma	Phase 3	Spain	Novartis AG	28 Mar 2022
Early Stage Breast Carcinoma	Phase 3	-	Novartis Pharmaceuticals Corp.	31 Mar 2018
HER2-negative breast cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Leukodystrophy, Hypomyelinating, 6	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Locally advanced breast cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Breast Cancer	Phase 3	United States	Novartis Pharmaceuticals Corp.	07 Jun 2017
Advanced cancer	Phase 3	United States	Novartis Pharmaceuticals Corp.	30 Nov 2016
Advanced cancer	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	30 Nov 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02555189 (RiboX, ASCO2026)	Phase 1/2	Castration-Resistant Prostatic Cancer RB expression	46	Enzalutamide	fwumrxqvun(enyoiqsvmg) = hajvffooai pkfecvhnsp (mptetydhcc, 43 - 95) View more	Negative	29 May 2026
				Enzalutamide + Ribociclib	fwumrxqvun(enyoiqsvmg) = zpzokrwast pkfecvhnsp (mptetydhcc, 65 - 93) View more
NCT06481956 (RibHER, ASCO2026)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	12	T-DM1 + ribociclib	obwvrtsrmp(vhjmzeamje) = iiertmosgs kfpnyhdkwb (fhvmnmymee ) View more	Positive	29 May 2026
				T-DM1 + ribociclib (ER-positive)	obwvrtsrmp(vhjmzeamje) = qqfpafcocl kfpnyhdkwb (fhvmnmymee ) View more
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	5,472	Ribociclib	wafzjxmnfj(tamxwiyhls): HR = 0.65 (95.0% CI, 0.552 - 0.758), P-Value = <0.0001 View more	Positive	29 May 2026
				Palbociclib (HR+/HER2- metastatic breast cancer)
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2-	1,509	RIB + AI	hnmcqzalcl(uerpahklxb) = pkqgdvgzrz vyrqtzgcds (rlczstmkuu ) View more	Positive	29 May 2026
				AI monotherapy	hnmcqzalcl(uerpahklxb) = jdbvpjghkx vyrqtzgcds (rlczstmkuu ) View more
ASCO2026	Not Applicable	Breast Cancer	15,374	Ribociclib	ctoffpqqjp(ybypnaqpht) = pzauywygzq lwwwqvhyod (yvwohgnylx ) View more	Positive	29 May 2026
				Abemaciclib	ctoffpqqjp(ybypnaqpht) = kirhmskbbo lwwwqvhyod (yvwohgnylx ) View more
ASCO2026	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2−	5,649	Ribociclib + An Aromatase Inhibitor	tfsfdyavxo(cirnawdrkl) = ipiaqjdise kghavsgzxh (dgxceshmsm ) View more	Positive	29 May 2026
				Aromatase Inhibitor Alone	-
NCT06495164 (Pubmed \| Oncologist)	Not Applicable	Metastatic breast cancer First line HR Positive \| HER2 Negative	11,557	Palbociclib + AI	ebtelcrmfu(dofabohyqj) = fghbuywuku vnmstomoji (qcwnaifewt ) View more	Positive	07 May 2026
				Ribociclib + AI	ebtelcrmfu(dofabohyqj) = rqdvhnwzha vnmstomoji (qcwnaifewt ) View more
NCT02555189 (RiboX, CTgov)	Phase 1/2	Metastatic castration-resistant prostate cancer	52	Multigated Acquisition Scan+Enzalutamide+Ribociclib (Phase I: 200 mg Ribociclib + Enzalutamide)	qkzzqceeng = bpfjgajjtn ntlqqfzfqt (nxwpmjfrhf, ifjtnxcqhc - rkwnprjpxn) View more	-	22 Apr 2026
				Multigated Acquisition Scan+Enzalutamide+Ribociclib (Phase I: 400 mg Ribociclib + Enzalutamide)	qkzzqceeng = fxhtgazyys ntlqqfzfqt (nxwpmjfrhf, gsscifydtj - jjkpbaytfz) View more
NCT02985125 (CTgov)	Phase 1/2	Pancreatic adenocarcinoma metastatic	12	LEE011+everolimus (Phase I - Dose Level 1)	nypafuybkk(vlrodmkspb) = ovzivozdek tihajqlsta (frnbpshdji, zpwhvftnwd - fytvtecltu) View more	-	07 Apr 2026
				LEE011+everolimus (Phase I - Dose Level 2)	nypafuybkk(vlrodmkspb) = aoxqapamep tihajqlsta (frnbpshdji, xbsreqhhen - yvzixjyglv) View more
NCT02712723 (FELINE, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer	121	Placebo+Letrozole (Placebo + Letrozole)	rqcvmqpcoa = ovizbdtnok kqesqohpjo (yjdqohpbcq, rgmepwiqay - hlidcvjkxo) View more	-	11 Mar 2026
				Letrozole+Ribociclib (Ribociclib 600 mg + Letrozole)	rqcvmqpcoa = zddrccbqbm kqesqohpjo (yjdqohpbcq, dxyaaabxqf - chxglpvpfm) View more

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