This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Start Date31 Dec 2025

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

NCT06291064

/ Not yet recruitingPhase 2IIT

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).
All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Chicago

NCT06525766

/ Not yet recruitingPhase 2IIT

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer

This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.

Start Date15 Oct 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Capecitabine

100 Translational Medicine associated with Capecitabine

100 Patents (Medical) associated with Capecitabine

12,498

Literatures (Medical) associated with Capecitabine

01 Dec 2025·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

Author: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Dihydropyrimidine enzyme activity and its effect on chemotherapy toxicity: importance of genetic testing

Article

Author: Villano, John L ; Pandey, Deepali ; Roberts, Danielle ; Williams, Abby ; Shamaei Zadeh, Alexia

PURPOSE:

Patients with partial or complete DPD deficiency have decreased capacity to degrade fluorouracil and are at risk of developing toxicity, which can be even life-threatening.

CASE:

A 43-year-old man with moderately differentiated rectal adenocarcinoma on capecitabine presented to the emergency department with complaints of nausea, vomiting, diarrhea, weakness, and lower abdominal pain for several days. Laboratory findings include grade 4 neutropenia (ANC 10) and thrombocytopenia (platelets 36,000). Capecitabine is used as a component of first-line adjuvant therapy by approximately 2 million patients worldwide each year. Capecitabine is metabolized to fluorouracil via the enzyme dihydropyrimidine dehydrogenase (DPD). With worsening pancytopenia and diarrhea, genetic testing for DPD deficiency was sent. Prompt treatment with uridine triacetate was initiated for presumed DPD deficiency. Unfortunately, he passed away from an infectious complication and was later confirmed to have a heterozygous DPYD*2A mutation.

DISCUSSION:

Our case demonstrates uneven testing guidelines for DPD prior to initiating 5-FU chemotherapy, appropriateness of treating with uridine triacetate, and analysis of next-generation sequencing (NGS) on tumor samples and co-incidentally obtaining germline DPD deficiency status. Our case also highlights the severe clinical impact of having DPD deficiency even with early uridine triacetate therapy.

CONCLUSION:

It is our recommendation to perform DPD deficiency in curative intent cancer treatment and this information can increasingly be obtained in standard tumor NGS profiling, a growing norm in medical oncology.

01 Dec 2025·Journal of Gastrointestinal Cancer

Nivolumab Combined with Chemotherapy in FGFR2 and PD-L1 Co-Expressing Metastatic Gastric Cancer: A Prospective Phase 2 NIVOFGFR2 Study

Article

Author: Guliyev, Fuad ; Otkhozoria, Nana ; Musayeva, Gunel ; Mahmudova, Samira ; Kahharov, Alisher ; Abbasov, Bahadur ; Tsimafeyeu, Ilya

BACKGROUND:

Immunotherapy is increasingly significant in treating metastatic gastric cancer. This prospective phase 2 study investigates the efficacy and safety of combining nivolumab with chemotherapy in patients with metastatic gastric cancer co-expressing FGFR2 and PD-L1.

METHODS:

Eligible patients were aged 18 years or older, with previously untreated HER-2 negative, PD-L1 positive, and FGFR2 positive metastatic gastric adenocarcinoma. Patients received nivolumab (360 mg every 3 weeks) in combination with chemotherapy (CAPOX: capecitabine 1000 mg/m² twice daily on days 1-14 and oxaliplatin 130 mg/m² on day 1, every 3 weeks). Tumor assessments were conducted using RECIST v1.1 every 8 weeks for 48 weeks, then every 12 weeks. The primary endpoint was the 1-year progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), objective response rate (ORR), and grade ≥ 3 adverse events (AEs).

RESULTS:

From June 2022 to October 2023, 194 patients were assessed for eligibility, with 23 patients enrolled and treated. At a median follow-up of 17.3 months, the 1-year PFS rate was 30.4%, with a median PFS of 6.0 months (95% CI, 4.3-7.7). The median OS was 15.1 months (95% CI, 13.2-16.8). The ORR was 21.7%, with one complete response and four partial responses. Grade 3 or higher TRAEs were reported in 34.8% of patients, primarily associated with chemotherapy. No treatment-related deaths occurred.

CONCLUSIONS:

While the primary endpoint of improved 1-year PFS rate was not met, the study offers valuable insights into the potential benefits of combining nivolumab with chemotherapy in FGFR2 and PD-L1 co-expressing metastatic gastric cancer. Future research should optimize patient selection, assess combined immunotherapy and targeted anti-FGFR2 therapy, and further investigate the role of subsequent treatments to maximize therapeutic benefits.

375

News (Medical) associated with Capecitabine

19 Mar 2025

·www.fda.gov

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).Pembrolizumab previously received accelerated approval for this indication on May 5, 2021, based on interim analysis of the trial described below.Full prescribing information for Keytruda will be posted on Drugs@FDA. Efficacy and SafetyEfficacy was evaluated in KEYNOTE-811 (NCT03615326), a multicenter, randomized, double-blind, placebo-controlled trial enrolling 698 patients with HER2-positive advanced gastric or GEJ adenocarcinoma not previously treated with systemic therapy for metastatic disease. Among the 698 patients, 594 (85%) had tumors expressing PD-L1 with a CPS ≥1 using the PD-L1 IHC 22C3 pharmDx kit. Patients were randomized (1:1) to pembrolizumab 200 mg or placebo, in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.The major efficacy outcome measures assessed in patients were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). Additional outcome measures included overall response rate (ORR) and duration of response (DOR). A statistically significant improvement in OS and PFS was demonstrated in patients randomized to pembrolizumab in combination with trastuzumab and chemotherapy compared with placebo in combination with trastuzumab and chemotherapy. In patients with tumors that were PDL1 CPS≥1, median PFS was 10.9 months (95% CI: 8.5, 12.5) in the pembrolizumab arm and 7.3 months (95% CI: 6.8, 8.4) in the placebo arm (Hazard ratio [HR] 0.72 [95% CI: 0.60, 0.87]). Median OS was 20.1 months (95% CI: 17.9, 22.9) and 15.7 months (95% CI: 13.5, 18.5) in the respective arms (HR 0.79 [95% CI: 0.66, 0.95]. ORR was 73% (95% CI: 68, 78) and 58% (95% CI: 53, 64) and median DOR was 11.3 months (95% CI: 9.9, 13.7) and 9.6 months (95% CI: 7.1, 11.2).The adverse reaction profile observed in patients receiving pembrolizumab was consistent with the known pembrolizumab safety profile.The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks in combination with trastuzumab and chemotherapy.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This drug development program was consistent with Project FrontRunner, an FDA Oncology Center of Excellence (OCE) initiative to encourage sponsors to develop cancer drugs for advanced or metastatic disease in an earlier line of treatment. This application was granted orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.

Drug ApprovalOrphan DrugClinical ResultAccelerated Approval

12 Mar 2025

·www.drugs.com

ASTRO Issues Clinical Guideline for Use of Radiation Therapy in Anal Cancer

WEDNESDAY, March 12, 2025 -- In a clinical practice guideline issued by the American Society for Radiation Oncology and published online Feb. 27 in Practical Radiation Oncology , evidence-based recommendations are presented to address indications for definitive treatment of primary squamous cell carcinoma of the anal canal and anal margin. Mary Feng, M.D., from the University of California in San Francisco, and colleagues recommend multidisciplinary evaluation and decision-making for all patients. For most patients, definitive treatment with combined modality therapy is recommended using concurrent 5-fluorouracil or capecitabine plus mitomycin, with cisplatin as a conditional alternative to mitomycin with radiation therapy (RT). Local excision alone may be considered for select patients with early-stage disease. The primary tumor/anal canal and rectum and mesorectal, presacral, internal and external iliac, obturator, and inguinal lymph nodes should be included in RT target volumes. The authors also present a recommendation for intensity-modulated RT-based treatment approaches. Depending on disease stage and RT approach and adapted for risk, the primary tumor should receive doses of 4,500 to 5,940 cGy in 25 to 33 fractions, and clinically involved lymph nodes should receive 5,040 to 5,400 cGy in 28 to 30 fractions. To minimize acute and chronic treatment-related toxicity, dose guidance for normal tissues and measures are provided by the guideline. Treatment breaks should be kept to a minimum. "Radiation therapy plays a central role in managing anal cancer , offering patients an effective, organ-preserving definitive treatment," Feng said in a statement. Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Radiation TherapyClinical Study

28 Feb 2025

·www.astrazeneca.com

AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the DESTINY-Breast06 Phase III trial, which were presented at the 2024 American Society of Clinical Oncology (ASCO) Meeting and published in The New England Journal of Medicine. In the trial, Enhertu showed a 38% reduction in the risk of disease progression or death versus chemotherapy (hazard ratio [HR] 0.62; confidence interval [CI] 0.52-0.75; p<0.0001) in patients with chemotherapy-naïve HR-positive, HER2-low metastatic breast cancer with a median progression-free survival (PFS) of 13.2 months versus 8.1 months. In the overall trial population (patients with HER2-low or HER2-ultralow metastatic breast cancer), the median PFS was 13.2 months in patients randomised to Enhertu compared to 8.1 months in those randomised to chemotherapy (HR 0.64; 95% CI 0.54-0.76; p<0.0001). In an exploratory analysis, results were seen to be consistent between patients with HER2-low expression and HER2-ultralow expression. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Endocrine therapy is typically used in the initial treatment of HR-positive metastatic breast cancer but as the disease progresses the benefit of continued endocrine therapy is limited, and subsequent standard-of-care chemotherapy is associated with poor outcomes. Enhertu has the potential to be the first HER2-directed treatment for patients in the EU with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer directly following endocrine therapy, which would mark an important shift in how patients in this setting are treated.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “Enhertu is the first HER2-directed treatment and antibody drug conjugate to show a progression-free survival of more than one year in patients with HER2-low or HER2-ultralow metastatic breast cancer following endocrine therapy. The CHMP recommendation is encouraging and supports our goal of further developing and advancing the way breast cancer is classified and treated.” HER2 status in the trial was confirmed by a central laboratory and was performed on a tumour sample obtained at the time of initial metastatic diagnosis or later. Approximately 85-90% of patients with HR-positive, HER2-negative metastatic breast cancer were determined to be HER2-low or HER2-ultralow.1 The safety profile of Enhertu in DESTINY-Breast06 was consistent with previous clinical trials of Enhertu in breast cancer with no new safety concerns identified. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Enhertu was recently approved in the US for patients with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer that has progressed on one or more endocrine therapies in the metastatic setting. In addition to the EU, regulatory applications are under review in Japan and several other countries based on the DESTINY-Breast06 results. Enhertu is already approved in more than 75 countries, including the EU, for patients with HER2-low metastatic breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Notes Breast cancer and HER2 expression Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.2 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.2 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually.3 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.4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.5 Patients with high levels of HER2 expression (IHC 3+ or 2+/ISH+) are classified as HER2-positive and treated with HER2-directed therapies, representing approximately 15-20% of all breast cancers.6 Historically, tumours that were not classified as HER2-positive were classified as HER2-negative.7 HR-positive, HER2-negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.4 Endocrine therapies are widely given consecutively in the early lines of treatment for HR-positive metastatic breast cancer. However, after initial treatment, further efficacy from endocrine therapy is often limited.8 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.8-11 Despite being classified as HER2-negative, many of these tumours may still carry some level of HER2 expression.7 In the DESTINY-Breast06 trial, approximately 85-90% of patients with HR-positive, HER2-negative metastatic breast cancer were determined to be HER2-low or HER2-ultralow.1 Prior to the approval of Enhertu in HER2-low metastatic breast cancer based on the DESTINY-Breast04 trial, there were no targeted therapies specifically approved for patients with HER2-low expression. There are no targeted therapies specifically approved in the EU for patients with HER2-ultralow expression.12,13 DESTINY-Breast06 DESTINY-Breast06 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) advanced or metastatic breast cancer. Patients in the trial had no prior chemotherapy for advanced or metastatic disease and received at least two lines of prior endocrine therapy in the metastatic setting. Patients were also eligible if they had received one prior line of endocrine therapy combined with a CDK4/6 inhibitor in the metastatic setting and experienced disease progression within six months of starting 1st-line treatment or received endocrine therapy as an adjuvant treatment and experienced disease recurrence within 24 months. The primary endpoint is PFS in the HR-positive, HER2-low patient population as measured by blinded independent central review (BICR). Key secondary endpoints include PFS by BICR in the overall trial population (HER2-low and HER2-ultralow), overall survival (OS) in the HER2-low patient population and OS in the overall trial population. Other secondary endpoints include objective response rate, duration of response, time to first subsequent treatment or death, time to second subsequent treatment or death and safety. DESTINY-Breast06 enrolled 866 patients (n=713 for HER2-low and n=153 for HER2-ultralow) in Asia, Europe, Australia, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4 mg/kg) is approved in the US for adult patients with unresectable or metastatic HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic settingbased on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population. Enhertu (5.4mg/kg) is approved in the US, Russia, Israel and Brazil for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on the results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. 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 tumour environment. With Enhertu, 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 Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. 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 Datroway alone and in combination with immunotherapy Imfinzi (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 catalyse 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/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation 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.com and follow the Company on social media @Astraeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. Salgado RF, et al. LBA21 - Human epidermal growth factor receptor 2 (HER2)-low and HER2-ultralow status determination in tumors of patients (pts) with hormone receptor–positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). Annals of Oncology. (2024) 35 (suppl_2): 1-72. 10.1016/annonc/annonc1623. 2. 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 Apr 4. doi: 10.3322/caac.21834. 3. WHO. International Agency of Cancer Research. Cancer Today. Breast. 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/20-breast-fact-sheet.pdf. Accessed February 2025. 4. National Cancer Institute. Surveillance, Epidemiology and End Results Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed February 2025. 5. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;852748. 6. Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med. 2020;54(1):34-44. 7. Sajjadi E, et al. Improving HER2 testing reproducibility in HER2-low breast cancer. Cancer Drug Resist. 2022;5(4):882-888. 8. Manohar P, et al. Updates in endocrine therapy for metastatic breast cancer. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. 9. Cortes J, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377:914-923. 10. Yuan P, et al. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019;112:57–65. 11. Jerusalem G, et al. Everolimus Plus Exemestane vs Everolimus or Capecitabine Monotherapy for Estrogen Receptor–Positive, HER2-Negative Advanced Breast Cancer. JAMA Oncol. 2018;4(10):1367–1374. 12. Modi S, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022;387:9-20. 13. Bardia A, et al. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer. N Eng J Med. 2024; 391:2110-2122. Adrian Kemp Company Secretary AstraZeneca PLC Oncology Corporate and financial

Phase 3Clinical ResultASCODrug ApprovalImmunotherapy

100 Deals associated with Capecitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D01223	Capecitabine	L01BC06	DB01101

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrooesophageal junction cancer	United States	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Pancreatic Cancer	United States	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Rectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	19 Sep 2016
Esophageal Carcinoma	Australia	Dr. Reddy's Laboratories (Australia) Pty Ltd.	24 Jun 2013
Locally advanced breast cancer	European Union	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	European Union	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	European Union	KRKA dd	20 Apr 2012
Locally advanced breast cancer	Iceland	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	Iceland	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Iceland	KRKA dd	20 Apr 2012
Locally advanced breast cancer	Liechtenstein	KRKA dd	20 Apr 2012
Locally advanced breast cancer	Liechtenstein	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	Liechtenstein	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Norway	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Norway	KRKA dd	20 Apr 2012
Locally advanced breast cancer	Norway	Accord Healthcare SLU	20 Apr 2012
Stomach Cancer	China	Chugai Pharmaceutical Co., Ltd.	17 Oct 2008
Breast cancer recurrent	Japan	CHEPLAPHARM Arzneimittel GmbH	12 Dec 2007
Colonic Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	30 Apr 2003
Advanced gastric carcinoma	European Union	CHEPLAPHARM Arzneimittel GmbH	02 Feb 2001

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	France	UNICANCER	11 Jun 2020
GRPR Positive/ER Positive/HER2 Negative Breast Cancer	Phase 3	France	UNICANCER	11 Jun 2020
Metastatic gastric adenocarcinoma	Phase 3	United States	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Japan	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Argentina	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Belgium	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Canada	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Czechia	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Denmark	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Finland	Eli Lilly & Co.	20 Jan 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01972919 (CTgov)	Phase 2	Pancreatic carcinoma non-resectable	23	Radiation Therapy+Gemcitabine+Capecitabine	qgpfivbjuj = fpltyzkdnt irecarqipw (eyfqqsabki, bivwfbzmfr - cdawlmtowq) View more	-	25 Mar 2025
NCT04380337 (SHORT-FOX, CTgov)	Phase 2	Rectal Cancer \| Rectal Adenocarcinoma	38	IMRT+LEUCOVORIN CALCIUM+irinotecan+oxaliplatin+capecitabine+Fluorouracil	sjvvrtsnqh = dhhggwxohl xlvkcxfcqq (parpxifwwt, mbggfazvcq - vausckouor) View more	-	25 Mar 2025
NCT03383679 (UCBG 3-06 START, Pubmed \| Lancet Oncol)	Phase 2	Advanced Triple-Negative Breast Carcinoma AR positivity	94	Darolutamide 600 mg	rxotcpeoyj(fsbikzldru) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) nmnjikcadx (pqspsduvop ) View more	Negative	01 Mar 2025
				Capecitabine minimum 1000 mg/m2
PRODIGE83-ACABi-PRONOBIL (ASCO_GI2025)	Not Applicable	Biliary Tract Neoplasms Adjuvant	324	Capecitabine	zrzfpgjsbc(mhxqedsbss) = 27% of grade 3-4 ilcpvkivwy (ihidnpriuy ) View more	Positive	23 Jan 2025
				capecitabine (No adjuvant treatment)
NCT02451553 (Phase I/Ib study of afatinib with capecitabine, ASCO_GI2025)	Phase 1	Solid tumor \| Neoplasms EGFR amplified \| EGFR/HER2/HER3 pathway alterations	41	Afatinib 20 mg	vkakvxouqi(pnejeyhgwu) = gvabtksjxf doltrbkmuk (ztxzhtisdf ) View more	Negative	23 Jan 2025
				Afatinib 30 mg	vkakvxouqi(pnejeyhgwu) = dccgcbxfmj doltrbkmuk (ztxzhtisdf ) View more
NCT02767661 (MECCA, Pubmed \| Literature) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Hormone Receptor Positive \| HER2 Negative	254	metronomic capecitabine + an aromatase inhibitor	jaqcmphsmh(gvkfpgyrxf) = mnumtclyho idczvycqmi (dctseyrhdk ) View more	Positive	02 Jan 2025
				An aromatase inhibitor	jaqcmphsmh(gvkfpgyrxf) = orhpkpduoc idczvycqmi (dctseyrhdk ) View more
NCT04324476 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	52	CAPOX/CAPIRI plus bevacizumab	anjeegldkq(jzhryusjjv) = jszshywztm hofxgvzbmm (ltfdvnrpcs, 9.0 - 12.4) View more	Positive	11 Dec 2024
ESMO_ASIA2024	Not Applicable	Head and Neck Neoplasms	101	Capecitabine 2000 mg + Cyclophosphamide 100 mg	lgxidsyfgs(igpufwkole) = most patients experiencing manageable Grade 1 mucositis xvormrnfag (rnxhtbjfel )	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Colorectal Cancer	214	capecitabine (Age ≥60 years)	rmfbmhavev(pofharlcso) = ubhcxnxmky impspdrhbk (hwaadbbepw )	-	07 Dec 2024
				Capecitabine monotherapy	rmfbmhavev(pofharlcso) = oljovrmuub impspdrhbk (hwaadbbepw )

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