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

NCT06780787

/ Not yet recruitingPhase 2IIT

Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer

This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, 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. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.

Start Date30 Jun 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Capecitabine

100 Translational Medicine associated with Capecitabine

100 Patents (Medical) associated with Capecitabine

12,271

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·CANCER CHEMOTHERAPY AND PHARMACOLOGY

DPYD genotype should be extended to rare variants: report on two cases of phenotype / genotype discrepancy

Article

Author: Goldwirt, Lauriane ; Teixeira, Luis ; Thomas, Fabienne ; Jacqz-Aigrain, Evelyne ; Vilquin, Paul ; Mourah, Samia ; Medard, Yves

The enzyme dihydropyrimidine dehydrogenase (DPD) is the primary catabolic pathway of fluoropyrimidines including 5 fluorouracil (5FU) and capecitabine. Cases of lethal toxicity have been reported in cancer patients with complete DPD deficiency receiving standard dose of 5FU or capecitabine. DPD is encoded by the pharmacogene DPYD in which more than 200 variants have been identified. Different approaches have been developed for screening DPD-deficiency, including DPYD genotyping and phenotyping. Plasma uracil ([U]) and dihydrouracil ([UH₂]) concentrations are routinely used as surrogate markers for systemic DPD activity: [U] ≥ 16 ng/ml and < 150 ng/ml, and [U] ≥ 150 ng/mL indicate partial and complete DPD deficient phenotype, respectively, while values of 5 or 10 for [UH2]/([U] ratio are often cited. Four clinically relevant DPYD defective variants (DPYD*13, DPYD*2A, p.Asp949Val and haplotype B3), are targeted in genetic testing via PCR. In practice, pretreatment [U], alone or combined with these 4 recommended DPYD alleles guides individual dosage selection, though this approach has limitations. This is illustrated by two cases showing discrepancy between DPD deficient phenotype and normal standard genotype. In these two cases, DPYD exome sequencing with Next Generation Sequencing identified rare inactive variants, establishing concordance between phenotype and genotype. In patient 1, [U] levels of 21.1 and 25.5 ng/mL, indicated partial deficiency though the targeted genotype was normal and 5FU dose was adjusted based on the phenotype. In patient 2, [U] levels of 16.2 and 15.2 ng/mL were near the 16 ng/ml threshold. With a normal genotype, he as considered non-deficient as targeted genotype was normal and the standard dose was administered. These two cases underscore the need to pair DPD phenotyping with whole DPYD gene sequencing, due to the frequent discrepancies between these pharmacogenetic tools, the burden of rare variants and ethnic differences in variant frequencies.

337

News (Medical) associated with Capecitabine

11 Feb 2025

·www.prnewswire.com

New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Approved in Thailand

NERLYNX® (neratinib) has been approved as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer[1] Approval coincides with the first appointment of field force employees, signifying the growth of Specialised Therapeutics in Thailand SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3] NERLYNX® (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."[1] In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.[4] In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.[5,6] NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company. "We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease." Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7] Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025. "We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible. "As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them." Ends. About NERLYNX NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12] NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong. About HER2-Positive (HER2+) Breast Cancer Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14] While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14] About the ExteNET Study[2-4,15] The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation. The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab. The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. About the NALA Study[5,6] The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia. The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086). The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA). Additional information can be found at . References: SOURCE Specialised Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalOrphan Drug

06 Feb 2025

·www.fda.gov

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer

On January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (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 setting.FDA also approved the Ventana’s PATHWAY anti-HER-2 (4B5) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic device to identify patients with HER2-ultralow (IHC 0 with membrane staining) breast cancer for treatment with Enhertu. This assay was previously approved to identify patients with HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer for treatment with Enhertu. Full prescribing information for Enhertu will be posted on Drugs@FDA. Efficacy and SafetyEfficacy was evaluated in DESTINY-Breast06 (NCT04494425), a randomized, multicenter, open-label trial in 866 adult patients with advanced or metastatic HR-positive breast cancer with HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) expression as determined by Ventana’s PATHWAY anti-HER-2 (4B5) Rabbit Monoclonal Primary Antibody assay and evaluated at a central laboratory. The trial excluded patients with prior chemotherapy for advanced or metastatic disease. Patients were randomized (1:1) to receive either fam-trastuzumab deruxtecan-nxki 5.4 mg/kg (N=436) by intravenous infusion every three weeks or physician’s choice of single agent chemotherapy (N=430, capecitabine 60%, nab-paclitaxel 24%, or paclitaxel 16%).The major efficacy outcome measure was progression-free survival (PFS) in patients with HER2-low breast cancer assessed by blinded independent central review (BICR) based on RECIST v1.1. Additional efficacy outcome measures were PFS assessed by BICR based on RECIST v1.1 in the overall population, overall survival (OS) in patients with HER2-low breast cancer, and OS in the overall population. The trial demonstrated a statistically significant improvement in PFS in patients with HER2-low breast cancer (n=713). Median PFS was 13.2 months in the fam-trastuzumab deruxtecan-nxki arm and 8.1 months in the chemotherapy arm (Hazard ratio [HR] 0.62 [95% CI: 0.52, 0.75]; p-value <0.0001). The trial also demonstrated a statistically significant improvement in PFS in the overall population. Median PFS was 13.2 and 8.1 months in the fam-trastuzumab deruxtecan-nxki and chemotherapy arms, respectively (HR 0.64 [95% CI: 0.54, 0.76]; p-value <0.0001). At the time of the PFS final analysis, OS data was immature, and a total of 335 (39%) patients had died across both trial arms in the overall population. In exploratory analyses in the HER2-ultralow subgroup (n=153 patients), median PFS was 15.1 months in the fam-trastuzumab deruxtecan-nxki arm and 8.3 months in the chemotherapy arm with a HR of 0.76 (95% CI: 0.49, 1.17). In patients with measurable disease at baseline, confirmed objective response rate (ORR) assessed by BICR was 65.7% and 30.8% in the fam-trastuzumab deruxtecan-nxki and chemotherapy arms, respectively. The most common adverse reactions (≥20%), including laboratory abnormalities, were decreased white blood cell count, decreased neutrophil count, nausea, decreased hemoglobin, decreased lymphocyte count, fatigue, decreased platelet count, alopecia, increased alanine aminotransferase, increased blood alkaline phosphatase, increased aspartate aminotransferase, decreased blood potassium, diarrhea, vomiting, constipation, decreased appetite, COVID-19 infection, and musculoskeletal pain.The recommended fam-trastuzumab deruxtecan-nxki dosage is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted priority review and breakthrough 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.

Clinical ResultPriority ReviewDrug ApprovalAccelerated Approval

03 Feb 2025

·www.pharmaceutical-technology.com

Pfizer’s colon cancer combo approval further supported by Phase III win

The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Credit: Shutterstock / NMK-Studio. Pfizer ’s metastatic colorectal cancer (mCRC) combination therapy has met one of the primary endpoints of improving progression-free survival (PFS) in a Phase III trial, further supporting a full approval. The company’s active-controlled, open-label BREAKWATER trial (NCT05217446) evaluating a combination of Pfizer’s Braftovi (encorafenib), Eli Lilly’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) met one of its dual primary endpoints, improving PFS. The trial investigated the combination in mCRC patients living with a BRAF V600E mutation who are treatment-naive. The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Additionally, the company has added that no new safety signals have been observed. In December 2024, the US Food and Drug Administration (FDA) granted accelerated approval to the combination therapy of Braftovi, Erbitux and mFOLFOX6. Although it is waiting on full analysis of the final results, Pfizer intends to present its findings in a meeting with the FDA to support full approval. Speaking ahead of World Cancer Day on 4 February, Pfizer’s chief oncology officer Roger Dansey said: “We are extremely pleased with the clinically meaningful PFS and OS results from the BREAKWATER study, which have the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes. “The Braftovi regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation.” The multi-centre BREAKWATER trial is also the first trial to be launched under the regulatory body’s Project FrontRunner, an initiative aimed at encouraging sponsors to seek approval for drugs for patients in an earlier stage of clinical treatment. This is as opposed to seeking approval for treatments designed for patients who have already undergone several therapies or treatment options. In the BREAKWATER trial patients were randomised to receive either 300mg of Braftovi and Erbitux alone or in combination with mFOLFOX6. The active control group received mFOLFOX6, FOLFOXIRI (Folinic acid, fluorouracil, oxaliplatin and irinotecan), or CAPOX (capecitabine and oxaliplatin) with or without bevacizumab. A BRAF mutation is a form of cancer in which the BRAF gene begins to cause certain cells to continue dividing without ever receiving a signal to stop. The V600E variant is one of the more common forms of BRAF mutation with the name defining the location and nature of the condition. While some BRAF mutations are susceptible to different forms of targeted therapy, other BRAF mutations are not. Elsewhere in the treatment of mCRC, Tizona Therapeutics has expanded its ongoing Phase Ib clinical trial of TTX-080, a novel antibody targeting human leukocyte antigen-G (HLA-G), in patients with the condition. Meanwhile, Johnson & Johnson has reported a 49% overall response rate in a colorectal cancer study with RYBREVANT.

Clinical ResultPhase 3Phase 1Accelerated ApprovalDrug Approval

100 Deals associated with Capecitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D01223	Capecitabine	L01BC06	DB01101

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Gastrooesophageal junction cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Pancreatic Cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Rectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	19 Sep 2016
Esophageal Carcinoma	AU	Dr. Reddy's Laboratories (Australia) Pty Ltd.	24 Jun 2013
Locally advanced breast cancer	EU	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	EU	KRKA dd	20 Apr 2012
Locally advanced breast cancer	EU	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	IS	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	IS	KRKA dd	20 Apr 2012
Locally advanced breast cancer	IS	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	LI	KRKA dd	20 Apr 2012
Locally advanced breast cancer	LI	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	LI	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	KRKA dd	20 Apr 2012
Locally advanced breast cancer	NO	Accord Healthcare SLU	20 Apr 2012
Stomach Cancer	CN	Chugai Pharmaceutical Co., Ltd.	17 Oct 2008
Breast cancer recurrent	JP	CHEPLAPHARM Arzneimittel GmbH	12 Dec 2007
Colonic Cancer	JP	Chugai Pharmaceutical Co., Ltd.	30 Apr 2003
Advanced gastric carcinoma	EU	CHEPLAPHARM Arzneimittel GmbH	02 Feb 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	FR	UNICANCER	11 Jun 2020
GRPR Positive/ER Positive/HER2 Negative Breast Cancer	Phase 3	FR	UNICANCER	11 Jun 2020
Metastatic gastric adenocarcinoma	Phase 3	US	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	JP	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	AR	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	BE	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CA	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CZ	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	DK	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	FI	Eli Lilly & Co.	20 Jan 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01972919 (CTgov)	Phase 2	Pancreatic carcinoma non-resectable	23	Radiation Therapy+Gemcitabine+Capecitabine	qftehcutef(ifwozyamhb) = wqiftnhwqw yvjdlhqzko (njqstoumhl, eghljiuexz - cxfjcdzqpa) View more	-	10 Feb 2025
PRODIGE83-ACABi-PRONOBIL (ASCO_GI2025)	Not Applicable	Biliary Tract Neoplasms Adjuvant	324	Capecitabine	ddptqazztr(dppjlvwifi) = 27% of grade 3-4 fvdbwrxicc (xzxmmxxwyi ) 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	scxvowjkbs(fceanyqjag) = xtsksifjms gphzaejykn (oiogaxbxgw ) View more	Negative	23 Jan 2025
				Afatinib 30 mg	scxvowjkbs(fceanyqjag) = vsxlbtgqzy gphzaejykn (oiogaxbxgw ) 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	cgeznemgms(ilvaihzwtt) = yzthrhukba xgwqsnxrcp (iqabwbywkz ) View more	Positive	02 Jan 2025
				An aromatase inhibitor	cgeznemgms(ilvaihzwtt) = eedmvaxdcw xgwqsnxrcp (iqabwbywkz ) View more
NCT04324476 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	52	CAPOX/CAPIRI plus bevacizumab	pqyudrzfdb(awjcrwfrak) = duaytndzhi cinosphzqj (nlikopfzcj, 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	senugusgkg(xdkecsxmop) = most patients experiencing manageable Grade 1 mucositis rshaqalplj (clxoqhjjgd )	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Colorectal Cancer	214	capecitabine (Age ≥60 years)	hfuhnacebo(stszrobytu) = ntvrgokhwh zifregxsmy (rhbujurbpn )	-	07 Dec 2024
				Capecitabine monotherapy	hfuhnacebo(stszrobytu) = hbzbbinvsu zifregxsmy (rhbujurbpn )
NCT03487666 (CTgov)	Phase 2	Triple Negative Breast Cancer	45	Nivolumab (Arm A- Nivolumab)	fuceoicphy(zsqrceaqkp) = asqmidcjyj uhdmctszyk (zhjydzygql, rddreixkpa - iigzvvzqdv) View more	-	03 Dec 2024
				Capecitabine (Arm B- Capecitabine)	fuceoicphy(zsqrceaqkp) = kbfpxeaist uhdmctszyk (zhjydzygql, denbcvkfhg - wwlfybukmv) View more
NCT03259035 (CCTG CO.28 \| NEO \| CO.28, CTgov)	Phase 2	Rectal Cancer	58	folinic acid+oxaliplatin+capecitabine+fluorouracil	golmiisdza(vcxaoehexw) = xgwvydujzx ihvwscgftq (mydhgdbthj, kvjwcgbspe - lsykodqpdk) View more	-	10 Oct 2024
NCT03691051 (PERMEATE, Pubmed \| EClinicalMedicine) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	78	Pyrotinib plus capecitabine	hfnztkihqi(grmyhqmfuj) = suoctsxnop niebpxuzaw (yrmdrlndqd, 24.4 - not reached) View more	Positive	01 Oct 2024
				Pyrotinibcapecitabine (Radiotherapy-naïve brain metastases)	hfnztkihqi(grmyhqmfuj) = pdxzhjgupc niebpxuzaw (yrmdrlndqd, 12.6 - 33.3) View more

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