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Platinum-based Chemotherapy

Platinum Chemotherapy for Triple-Negative Breast Cancer

Phase 3

Waitlist Available

Led By Ingrid Mayer

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have completed neoadjuvant taxane +/- anthracycline; cisplatin, carboplatin, or capecitabine not received as part of neoadjuvant therapy regimen

Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 6 months after randomization

Awards & highlights

Study Summary

This trial is comparing two types of chemotherapy drugs to see which is more effective in treating patients with residual triple negative basal-like breast cancer.

Who is the study for?

This trial is for adults with triple-negative breast cancer that remains after initial chemotherapy and surgery. Participants must have completed neoadjuvant taxane +/- anthracycline therapy, not received cisplatin, carboplatin, or capecitabine as part of this regimen, and meet certain health criteria like specific blood cell counts and liver function.Check my eligibility

What is being tested?

The study compares the effectiveness of platinum-based chemotherapy (cisplatin or carboplatin) versus capecitabine in patients with residual basal-like triple-negative breast cancer post-surgery. It aims to determine which treatment better stops tumor growth by killing cells or preventing their spread.See study design

What are the potential side effects?

Common side effects may include nausea, fatigue, hair loss, nerve damage leading to numbness or tingling sensations (neuropathy), low blood cell counts increasing infection risk and bleeding problems, kidney issues from platinum drugs; hand-foot syndrome and diarrhea from capecitabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I completed a specific chemotherapy regimen without cisplatin, carboplatin, or capecitabine.

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I have not received any chemotherapy after surgery that is not listed in this study.

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I had surgery to remove my cancer completely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 6 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 6 months after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 6 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients

Secondary outcome measures

3-year Overall Survival (OS) Rate in Basal-Subtype Patients

3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients

Health-related Quality of Life (HRQL) at 15-month Assessment

+2 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Ischaemic stroke

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (cisplatin or carboplatin)Experimental Treatment2 Interventions

Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (observation) (closed to accrual 05/16/2016)Active Control1 Intervention

Patients undergo observation.

Group III: Arm C (capecitabine)Active Control1 Intervention

Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Cisplatin

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,507 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,738 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Ingrid MayerPrincipal InvestigatorECOG-ACRIN Cancer Research Group

2 Previous Clinical Trials

142 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02445391 — Phase 3

Breast Cancer Research Study Groups: Arm A (observation) (closed to accrual 05/16/2016), Arm B (cisplatin or carboplatin), Arm C (capecitabine)

Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02445391 — Phase 3

Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02445391 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

On how many hospital campuses is this research being conducted?

"There are plenty of places where you can receive this treatment as there are 100 sites. Some include Palo Alto Medical Foundation-Camino Division in Mountain View, Memorial Medical Center in Modesto, and Norwalk Hospital in Norwalk."

Answered by AI

What treatments or procedures is this clinical trial testing?

"The key aim of this study, as measured by the 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients, is to assess the efficacy of the intervention over a 86 month period. Additionally, researchers will collect data on health-related quality of life at 6 and 15 months (as measured by the Functional Assessment of Cancer Therapy Breast Symptom Index Treatment Side Effects subscale score) and rate of basal-like gene expression using PAM50 analysis by digital mRNA quantification."

Answered by AI

What is the current status of capecitabine in regards to government regulation?

"There is some evidence from past clinical trials to support the efficacy of capecitabine, as well as numerous rounds of data collected on its safety. For these reasons, it receives a score of 3."

Answered by AI

Are there any previous cases of research with capecitabine?

"At present, there are 1529 clinical trials underway that involve capecitabine. 513 of those active trials are in Phase 3. While the many studies for Capecitabine are based in Guangzhou, Guangdong, there are 74194 locations running trials for this treatment globally."

Answered by AI

How many willing participants are being registered for this research?

"This study is no longer admitting new patients. It was originally posted on 4/29/2015, and the last update was on 9/7/2022. However, there are presently 4721 trials actively recruiting participants with breast cancer and 1529 trials for Capecitabine that are still enrolling patients."

Answered by AI

What is the main condition that capecitabine has been shown to alleviate?

"While capecitabine is most often used to treat non-hodgkin lymphoma, it can also offer benefits to patients with advanced sarcoma, duke's c colon cancer, and neoplasm metastasis."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Randomized Phase III Postoperative Trial of Platinum-based Chemotherapy Versus Capecitabine in Patients with Residual Triple-negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131

Mayer, Ingrid A., Fengmin Zhao, Carlos L. Arteaga, William F. Symmans, Ben H. Park, Brian L. Burnette, Amye J. Tevaarwerk, et al.. 2021. “Randomized Phase III Postoperative Trial of Platinum-based Chemotherapy Versus Capecitabine in Patients with Residual Triple-negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00976.

clinicaltrials.govStudy

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

2015. "Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02445391.

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