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

Conditions

• Estrogen Receptor Negative
• HER2/Neu Negative
• Invasive Breast Carcinoma
• Progesterone Receptor Negative
• Stage II Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage III Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
  Given PO
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV

Study Details

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin 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. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.

Key Dates

First listed

May 15, 2015

Start date

Oct 20, 2015

Status verified

Jul 2026

Primary completion

Apr 7, 2021

Completion

Mar 29, 2031

Study Design

Enrollment

415 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Arm A (observation) (closed to accrual 05/16/2016)
  Patients undergo observation.
• Experimental: Arm B (cisplatin or carboplatin)
  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.
• Active Comparator: Arm C (capecitabine)
  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.

Primary Outcome Measure

3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients [ Time Frame: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years. ]

Locations (1023)

Find similar trials in Mobile, AL

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