Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Cyclophosphamide; Epirubicin; Pirarubicin

Criteria

Inclusion Criteria:

• Patients with histologically confirmed invasive adenocarcinoma of the breast.

• Triple negative breast cancer: hormone receptor negative (ER < 10% and PgR < 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.

• Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.

• Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.

• Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.

• Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.

• ECOG Performance Status: 0-1.

• Patients without severe heart, lung, liver and kidney disease.

• Adequate hematologic and end-organ function.

• No more than 6 weeks may elapse between definitive breast surgery and randomization.

Exclusion Criteria:

• Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).

• Previous neoadjuvant chemotherapy with platinum or taxanes alone.

• Patients have received other adjuvant therapy.

• Comprehensive medical examinations have revealed distant metastases before randomization.

• Patients who are not suitable for anthracycline evaluated by investigators.

• Prior history of other malignancy (except carcinoma in situ).