A phase III, randomized, open-label study evaluating efficacy and safety of Giredestrant compared with Fulvestrant, both combined with a CDK4/6 inhibitor, in patients with estrogen receptor-positive, HER2-negative advanced breast cancer with resistance to prior adjuvant endocrine therapy - PionERA

Start Date15 May 2024

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+1]

NCT05708235

/ Active, not recruitingPhase 2

A Proof of Concept Study to Evaluate Treatments' Efficacy by Monitoring Minimal Residual Disease Using ctDNA in HR-positive/HER2-negative Early Breast Cancer Population

This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease.
The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase).
After informed consent is obtained, a total of1,260 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature).
At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy:
Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10)
If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.

Start Date01 Apr 2024

Sponsor / Collaborator

Medica Scientia Innovation Research SL

NCT06259929

/ Not yet recruitingPhase 2IIT

NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer

The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC).
Primary objective:
● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2.
Secondary objectives:
To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2
To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response;
To evaluate the safety of abemaciclib and giredestrant.
Exploratory objectives:
To evaluate the mechanisms of response and resistance to therapy;
To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction;
To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

Start Date01 Apr 2024

Sponsor / Collaborator-

100 Clinical Results associated with Giredestrant

100 Translational Medicine associated with Giredestrant

100 Patents (Medical) associated with Giredestrant

Literatures (Medical) associated with Giredestrant

01 Nov 2024·CANCER TREATMENT REVIEWS

Oral SERDs changing the scenery in hormone receptor positive breast cancer, a comprehensive review

Review

Author: Gheysen, Mathilde ; Neven, Patrick ; Wildiers, Hans ; Punie, Kevin

BACKGROUND:

Primary and acquired endocrine resistance remains a major issue in the treatment of hormone receptor positive breast cancer. Acquired resistance often results from estrogen receptor 1 (ESR1) mutations leading to estrogen independent estrogen receptor activation. Selective estrogen receptor degraders (SERDs) induce degradation of this receptor, thereby overcoming this resistance. The intramuscular administration and modest efficacy of fulvestrant, the first SERD, triggered development of oral, more potent SERDs. This narrative review gives an overview of the current evidence regarding this new drug class.

METHODS:

Medline/PubMed and Embase database were screened using a systematic search strategy. We assessed the San Antonio Breast Cancer Symposium abstract reports, the European Society of Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) meeting resources by applying the following terms: 'SERD', 'giredestrant', 'elacestrant', 'imlunestrant', 'amcenestrant', 'camizestrant' and 'rintodestrant'.

CLINICALTRIALS:

gov was consulted to include ongoing trials.

RESULTS:

The search retrieved 1191 articles. After screening, 108 articles were retained. In the phase 3 EMERALD trial, elacestrant demonstrated benefit in progression free survival (PFS) in second line metastatic disease in postmenopausal women or men, leading to Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval for the ESR1 mutated population. This PFS advantage was more pronounced among patients who had priorly received at least 12 months of a cyclin-dependent kinases 4/6 inhibitor (CDK4/6i). In the phase 2 SERENA-2 trial, camizestrant improved PFS as second line treatment. However, trials of giredestrant and amcenestrant failed to show PFS benefit in second line metastatic setting. In the preoperative setting, several oral SERDs resulted in a significant reduction of tumoral proliferation. Furthermore, many trials are still in progress.

CONCLUSION:

Oral SERDs constitute an exciting new drug class. Ongoing and future research will further refine the role of these drugs next to standard endocrine treatments and targeted therapies.

01 Aug 2024·DRUG METABOLISM AND DISPOSITION

Mass Balance, Metabolic Pathways, Absolute Bioavailability, and Pharmacokinetics of Giredestrant in Healthy Subjects

Article

Author: Yu, Jiajie ; Tang, Yang Thomas ; Osaghae, Uyi ; Chen, Ya-Chi ; Zhao, Weiping ; Gates, Mary R ; Kawakatsu, Sonoko ; Khojasteh, S Cyrus ; Musib, Luna ; Zhang, Donglu ; De Bruyn, Tom ; Wang, Jing ; Kshirsagar, Smita ; Ma, Shuguang ; Malhi, Vikram ; Cho, Sungjoon

Giredestrant is a potent and selective small-molecule estrogen receptor degrader. The objectives of this study were to assess the absolute bioavailability (aBA) of giredestrant and to determine the mass balance, routes of elimination, and metabolite profile of [¹⁴C]giredestrant. In part 1 (mass balance), a single 30.8-mg oral dose of [¹⁴C]giredestrant (105 µCi) was administered to women of nonchildbearing potential (WNCBP; n = 6). The mean recovery of total radioactivity in excreta was 77.0%, with 68.0% of the dose excreted in feces and 9.04% excreted in urine over a 42-day sample collection period. The majority of the circulating radioactivity (56.8%) in plasma was associated with giredestrant. Giredestrant was extensively metabolized, with giredestrant representing only 20.0% and 1.90% of the dose in feces and urine, respectively. All metabolites in feces resulted from oxidative metabolism and represented 44.7% of the dose. In part 2 (aBA), WNCBP (n = 10) received an oral (30-mg capsule) or intravenous (30-mg solution) dose of giredestrant. The aBA of giredestrant after oral administration was 58.7%. Following the intravenous dose, giredestrant had a plasma clearance and volume of distribution of 5.31 L/h and 266 L, respectively. In summary, giredestrant was well tolerated, rapidly absorbed, and showed moderate oral bioavailability with low recovery of the dose as parent drug in excreta. Oxidative metabolism followed by excretion in feces was identified as the major route of elimination of giredestrant. SIGNIFICANCE STATEMENT: This study provides definitive insight into the absorption, distribution, metabolism, and excretion of giredestrant in humans. The results show that giredestrant exhibits low clearance, a high volume of distribution, and moderate oral bioavailability in humans. In addition, the data show that oxidative metabolism followed by excretion in feces is the primary elimination route of giredestrant in humans. These results will be used to further inform the clinical development of giredestrant.

01 Jul 2024·Cancer chemotherapy and pharmacology

UGT1A4 Polymorphism is not Associated with a Clinically Relevant Change in Giredestrant Exposure

Article

Author: Chen, Ya-Chi ; Nowicka, Malgorzata ; Yu, Jiajie ; Waldvogel, Marie ; Hafner, Marc ; Malhi, Vikram ; Lien, Yi Ting Kayla ; Moore, Heather M ; Agarwal, Priya ; Perez-Moreno, Pablo

Abstract:

Purpose:

Giredestrant is a potent, orally bioavailable, small-molecule selective estrogen receptor antagonist and degrader (SERD) that is being developed for the treatment of patients with estrogen receptor (ER)-positive breast cancer. In vitro, giredestrant was primarily metabolized by UGT1A4. The goal of this study was to investigate if UGT1A4 polymorphism had a clinically relevant impact on giredestrant exposure.

Methods:

Genotyping and pharmacokinetic data were obtained from 118 and 61 patients in two clinical studies, GO39932 [NCT03332797] and acelERA Breast Cancer [NCT04576455], respectively.

Results:

The overall allelic frequencies of UGT1A4*2 and UGT1A4*3 were 3.3% and 11%, respectively. Giredestrant exposure was consistent between patients with wild-type UGT1A4 and UGT1A4*2 and *3 polymorphisms, with no clinically relevant difference observed. In addition, haplotype analysis indicated that no other UGT1A4 variants were significantly associated with giredestrant exposure.

Conclusion:

Therefore, this study indicates that UGT1A4 polymorphism status is unlikely a clinically relevant factor to impact giredestrant exposure and giredestrant can be administered at the same dose level regardless of patients’ UGT1A4 polymorphism status.

News (Medical) associated with Giredestrant

10 Dec 2024

·endpts.com

Olema Oncology makes case for its oral SERD with fresh data cut from early breast cancer trial

Olema Oncology unveiled new data from a Phase 1b/2 breast cancer trial on Tuesday, as it strives to catch up with other companies with oral selective estrogen receptor degraders (SERDs). Olema’s vision is to co-administer palazestrant with front-line standard-of-care CDK4/6 inhibitors, such as Novartis’ Kisqali, in patients with advanced or metastatic ER-positive, HER2-negative breast cancer. The company says giving patients this combination could limit resistance to CDK4/6 inhibitors. Several companies, including Eli Lilly and Pfizer in partnership with Arvinas, are also at this year’s San Antonio Breast Cancer Symposium to report data from their respective oral SERDs. The new cut from Olema’s open-label trial focuses on 62 patients. After a year, the median progression-free survival had not been reached at the data cutoff of November 11, the company said. Among all patients, the six-month PFS rate was 73%, and 68% among those who received prior CDK4/6 plus endocrine therapy. The company said that palazestrant is a complete estrogen receptor antagonist as well as a SERD, and can thus treat both ESR1 mutated patients, in whom SERDs work best, and wild-type patients. Among ESR1-mutant patients, the six-month PFS rate was 81%. Importantly, it was 70% in wild-type patients, which is a “huge differentiator,” Olema CEO Sean Bohen told Endpoints News. “[We have shown] post CDK4/6, with the predominant population being wild type, what appears to be a very favorable PFS,” Bohen said. The palazestrant/Kisqali regimen could capture benefits across the whole patient population, which would be “a unique opportunity,” he said. Olema also disclosed two confirmed complete responses, eight confirmed partial responses and one unconfirmed partial response, giving an overall response rate of 27% among 37 response-evaluable patients with measurable disease. Patients in the trial had received palazestrant at increasing doses of up to 120 mg once daily, plus Kisqali. Bohen said 48 patients (77%) were second-, third- or later-line, and the rest were “previously untreated in the advanced or metastatic setting.” Perhaps the best comparators for Olema’s Tuesday data are those from the academic MAINTAIN trial. That study recruited patients with prior CDK4/6 treatment, 82% of whom were given AstraZeneca’s Faslodex, an endocrine therapy, plus Kisqali. In the overall MAINTAIN population, the six-month PFS rate was 41% and the mPFS was 5.3 months. Olema’s data clearly beat these. “The median follow-up [for Olema’s SERD] was 12 months and we’re still not at the median PFS,” Bohen said. “When do we hit that? We don’t know.” An earlier cut from this Phase 1b/2 trial, up to September 25, will be presented at the San Antonio Breast Cancer Symposium on Wednesday. Next year, Olema will kick off the pivotal OPERA-2 trial of the palazestrant/Kisqali combo in the first-line setting, and last week secured a supply of Novartis’s drug. However, other SERDs are already well into Phase 3 development in frontline disease. Expectations are particularly high for Roche’s giredestrant, whose PersevERA trial in combination with Pfizer’s CDK4/6 inhibitor Ibrance could report next year. Elsewhere, Olema is currently conducting a Phase 3 study, OPERA-1, of palazestrant monotherapy in second-line ER-positive, HER2-negative breast cancer, which Bohen said could lead to the monotherapy’s approval as second- and third-line therapy.

Phase 3Clinical ResultASCO

30 Sep 2024

·www.fiercebiotech.com

Roche celebrates Pharma Day by buying Regor's CDK inhibitors, regenerative med-focused AntlerA

Buying RGT-419B continues Roche’s push into HR-positive breast cancer. Genentech is paying $850 million upfront for Regor Pharmaceuticals’ portfolio of CDK inhibitors, taking ownership of a breast cancer candidate that has shown signs of single-agent efficacy in patients failed by existing options. The deal was announced on Roche's Pharma Day, where the Swiss Big Pharma—which owns Genentech—also disclosed (PDF) the acquisition of Wnt signaling-focused biotech AntlerA Therapeutics.Regor, a Chinese-American biotech, presented phase 1a results on its next-generation CDK inhibitor late last year. The biotech designed the drug candidate to have high potency against CDK4, additional activity versus CDK2 and selectivity against CDK6. Those features are intended to overcome resistance to CDK4/6 inhibition and reduce hematologic toxicity.The biotech is testing the molecule, which is called RGT-419B, in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients who progressed on prior CDK4/6 inhibitors. All 12 of the women in the analysis had previously received Pfizer’s CDK4/6 inhibitor Ibrance. Two patients had also taken Novartis’ Kisqali or Eli Lilly’s Verzenio, other approved CDK inhibitors.Regor saw (PDF) two confirmed and one unconfirmed partial responses during dose escalation. The monotherapy’s 28.6% confirmed partial response rate in seven patients with measurable disease, plus absence of grade 3 or higher adverse events, led Regor to plan dose expansions of RGT-419B as a single agent and in combination with endocrine therapy. The biotech will manage two ongoing phase 1 trials of RGT-419B to completion. After that, Genentech will be responsible for clinical development, manufacturing and commercialization worldwide. As the CDK inhibitors advance, Genentech could pay development, regulatory and commercial milestones of undisclosed size.Buying RGT-419B continues Roche’s push into HR-positive breast cancer, which represents around 70% of all cases. The Swiss drugmaker is developing giredestrant, a selective endocrine receptor degrader, and inavolisib, a PI3K inhibitor, in HR-positive disease. Roche sees giredestrant as a potential replacement for endocrine therapies that combines tolerably with CDK inhibitors. The ability to combine inavolisib with CDK inhibitors is central to Roche’s attempt to differentiate the PI3K inhibitor.To date, Roche has paired its candidates with CDK inhibitors from Lilly, Novartis and Pfizer. Genentech’s acquisition of the Regor portfolio, which is expected to close in the fourth quarter, will give Roche its own CDK inhibitors.After selling the CDK inhibitor portfolio, Regor will focus on its remaining oncology, metabolic disease and autoimmune assets. The pipeline is led by an oral GLP-1 receptor agonist that is in clinical development in diabetes and obesity. Lilly partnered with the biotech to work on metabolic disorders in 2021. Meanwhile, the acquisition of AntlerA, which Roche called a leader in Wnt signaling, gives the pharma ownership of a library of anti-FZD/LRP drug candidates. Roche sees AntlerA’s preclinical lead asset as a potential best-in-class treatment for neovascular age-related macular degeneration and diabetic macular edema.Roche wouldn't disclose the financial details of the deal, but a spokesperson told Fierce Biotech that the biotech's pipeline is “a strong fit with our interest in ophthalmology and ... the Wnt pathway could be very promising for the treatment of other diseases.”Today's oncology and eye-focused deals strengthen Roche’s pipeline in two of the five priority areas for its new pharma strategy, which the company reaffirmed at its Pharma Day in London this morning. Roche’s 10-year ambition is to deliver 20 transformative medicines addressing diseases with the highest societal burden, executives explained to attendees at the event.

Phase 1AcquisitionClinical Result

14 Feb 2024

·www.biospace.com

Carrick Therapeutics Announces First Patient Dosed in Phase 1b/2 Clinical Trial of Samuraciclib in Combination with Vepdegestrant in Patients with Advanced Breast Cancer

BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics, Ltd., an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor (ER) degrader, being jointly developed by Arvinas (Nasdaq: ARVN) and Pfizer (NYSE: PFE) in women with ER+, HER2- metastatic breast cancer who have previously received a CDK4/6 inhibitor. “We’re excited to expand clinical development of samuraciclib with our Phase 1b/2 clinical trial evaluating the combination of samuraciclib and vepdegestrant, another step forward in addressing an important need for patients with advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “We believe there is great potential for this combination treatment, based on the encouraging initial clinical trial data for vepdegestrant and Pfizer’s deep expertise in developing treatments for breast cancer.” The Phase 1b/2 clinical trial has two parts. In Phase 1b, escalating doses of samuraciclib and vepdegestrant will be tested to determine appropriate doses of each therapy to be used in combination. In Phase 2, additional patients will be enrolled to further explore the safety and efficacy of the selected doses. This clinical trial evaluating the novel combination of samuraciclib and vepdegestrant is being conducted as part of the TACTIVE-U study in collaboration with Arvinas and Pfizer under a clinical trial collaboration and supply agreement. Clinical trial details can also be found on under study ID: NCT06125522. For additional information on the clinical trial, please contact hello@carricktherapeutics.com. About Vepdegestrant (ARV-471) Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits. Ongoing and planned clinical trials will continue to monitor and evaluate the safety and anti-tumor activity of vepdegestrant. About Samuraciclib (CT7001) Samuraciclib is the most advanced CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and promotes resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety pro encouraging efficacy in early clinical studies. In addition to the above studies, samuraciclib has further potential in prostate, pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer. Carrick is collaborating with Roche, Menarini Group and Arvinas/Pfizer to evaluate novel combinations of samuraciclib with Roche’s oral SERD giredestrant, Menarini Group’s oral SERD elacestrant, and Arvinas/Pfizer’s proteolysis targeting chimera (PROTAC) Estrogen Receptor degrader vepdegestrant (ARV-471) in late-stage CDK4/6i resistant HR+, HER2- metastatic breast cancer. About Carrick Therapeutics Carrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel CDK7 inhibitor currently in Phase 2 clinical trials for HR+ breast cancer. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is expected to enter a Phase 1 clinical trial in mid-2024. For more information about Carrick Therapeutics, please visit Carrick Contacts Carrick Therapeutics Jenny Horsfield, Chief Business Officer jenny.horsfield@carricktherapeutics.com Investors and Media Luke Heagle, Real Chemistry lheagle@realchemistry.com

Phase 2Fast TrackPhase 1

100 Deals associated with Giredestrant

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	Phase 3	US	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	JP	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	AR	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	DE	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	GR	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	IT	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	SG	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	ZA	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	KR	Genentech, Inc.	03 Aug 2022
Estrogen receptor positive breast cancer	Phase 3	ES	Genentech, Inc.	03 Aug 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04802759 (MORPHEUS- BREAST CANCER, ESMO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer HER2 Negative \| ER Positive	33	Giredestrant 30 mg PO daily	hfokmwtsmv(wsnfkqacuf) = pyhapxrcgx dobcxpfamw (gwcgypdwtt ) View more	Positive	16 Sep 2024
				Giredestrant 30 mg PO daily + Samuraciclib 360 mg PO daily	hfokmwtsmv(wsnfkqacuf) = swhpdbvxox dobcxpfamw (gwcgypdwtt ) View more
NCT04576455 (acelERA BC, Pubmed) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Estrogen Receptor-Positive \| HER2-Negative	303	Giredestrant	gnftazilzz(rxiuuptfxf): HR = 0.81 (95% CI, 0.6 - 1.1), P-Value = 0.1757 View more	Positive	20 Jun 2024
				fulvestrant choice of endocrine monotherapy
NCT04802759 (ASCO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer HER2 Negative	15	Giredestrant (G) + Everolimus (EVERO)	ngcodublge(bvsjbzmemq) = hohydfmqcv iwlyptkzvq (lknjgxzkii ) View more	Positive	24 May 2024
NCT03332797 (GO39932, Pubmed)	Phase 1	ER+ \| HER2-negative \| ESR1-mutated tumors	175	Giredestrant 10 mg	auxcxrmqah(rkztcffupr) = oaesjyzbxb yqougyxlhf (nfgsfvcpgw )	Positive	23 Jan 2024
				Giredestrant 30 mg	auxcxrmqah(rkztcffupr) = grfnybkijq yqougyxlhf (nfgsfvcpgw )
NCT03332797 (phase Ia/Ib dose-escalation/-expansion study, Pubmed)	Phase 1	Advanced breast cancer	-	Giredestrant 10 mg	dgyzsbpbde(kodglrsaop) = tmgnohxsba titxmajjdd (olbnnjbmky )	Positive	15 Dec 2023
				Giredestrant 30 mg	dgyzsbpbde(kodglrsaop) = fxdqdniaok titxmajjdd (olbnnjbmky )
NCT04436744 (coopERA Breast Cancer, Pubmed \| Lancet Oncol)	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant oestrogen receptor-positive \| HER2-negative \| Ki67 score	221	Giredestrant 30 mg	rqccozncjx(msmsceqheg) = vehmpfjvfa kjvylmvdqj (foonxjbgci, -80 to -70)	Positive	01 Sep 2023
				Anastrozole 1 mg	rqccozncjx(msmsceqheg) = zylfuzfcbw kjvylmvdqj (foonxjbgci, -73 to -59)
NCT04436744 (coopERA BC, ASCO 12023 \| ASCO 22023) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant ER Positive \| HER2 Negative	-	Palbociclib+Giredestrant	rbvugdpvhd(whqjvpocsm) = qotopdshsm ckgxqpijdd (luukawhkle ) View more	Positive	26 May 2023
				Palbociclib+anastrozole	rbvugdpvhd(whqjvpocsm) = tistyweiph ckgxqpijdd (luukawhkle ) View more
NCT04802759 (MORPHEUS BC, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER Positive \| HER2 Negative	40	Abemaciclib+Giredestrant	uscvuenpel(hvpxvfwfhl) = nzwzlijoic igvrqkezap (xhgmjqjjqy ) View more	Positive	26 May 2023
				ribociclib +Giredestrant	uscvuenpel(hvpxvfwfhl) = hoibxidxwp igvrqkezap (xhgmjqjjqy ) View more
NCT03916744 (CTgov)	Phase 1	Estrogen receptor positive breast cancer	75	Surgery+Giredestrant (Giredestrant 10 mg)	jmfmrnzxhk(tstwqllyxd) = pxamjgvouc sowjqxouga (gwmkknxbcm, htmomkzbbp - lomkpbzmck) View more	-	10 Mar 2023
				Surgery+Giredestrant (Giredestrant 30 mg)	jmfmrnzxhk(tstwqllyxd) = jhsmyphrju sowjqxouga (gwmkknxbcm, khuzhtoebr - yjlmvrjmjl) View more
NCT04436744 (coopERA \| coopERA BC \| coopERA Breast Cancer, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Early Stage Breast Carcinoma	221	Surgery+Giredestrant+palbociclib (Giredestrant + Palbociclib)	fkwvfiusml(fhxudualnv) = oedcjcyykf ueqlkraweq (zofpnccyes, nnfjetozrm - zbzjhjunem) View more	-	02 Feb 2023
				Surgery+palbociclib+anastrozole (Anastrozole + Palbociclib)	fkwvfiusml(fhxudualnv) = nvjsvoqiny ueqlkraweq (zofpnccyes, zrwnzdgsuj - pbtanehdya) View more

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