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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

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

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.

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.

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:

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I had triple-negative breast cancer within the last 5 years and no other cancers.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met