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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
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening
Female and male patients with histologically confirmed invasive breast cancer meeting specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 6 months after randomization
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

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 am fully active or restricted in physically strenuous activity but can do light work.
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I have been diagnosed with invasive breast cancer.
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I completed a specific chemotherapy regimen without cisplatin, carboplatin, or capecitabine.
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I had surgery to remove my cancer completely.
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I have a preserved tissue sample from my surgery available for analysis.
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I have not received any chemotherapy after surgery that is not listed in this study.
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My tumor sample is ready to be sent for analysis within 21 weeks after surgery.
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I can receive radiotherapy before or after the trial treatment as per standard guidelines.

Timeline

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
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
114 Previous Clinical Trials
175,647 Total Patients Enrolled
4 Trials studying Breast Cancer
3,528 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,586 Previous Clinical Trials
41,241,784 Total Patients Enrolled
938 Trials studying Breast Cancer
1,542,336 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
~44 spots leftby Feb 2025