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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
Must not have
History of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 6 months after randomization
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had triple-negative breast cancer within the last 5 years and no other cancers.

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%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
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)

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
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
13,748 Previous Clinical Trials
40,958,986 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 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
~43 spots leftby Jul 2025
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