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Recruiting Phase 2

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

NCT04437160 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2020-02-01
Last updated
2020-06-18

Condition(s) studied

Triple Negative Breast Cancer

Investigational drug(s) / intervention(s)

Epirubicin or PirarubicinAll Epirubicin trials (50) →All Pirarubicin trials (5) →Cyclophosphamide →

Epirubicin or Pirarubicin: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\*4cycls

Cyclophosphamide: Cyclophosphamide 600mg/m2 IV, q21d\*4cycls

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • RFS — median 5 years
    RFS defined as the time from randomization to the first recurrence event or death through the end of study

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS) Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04437160 on ClinicalTrials.gov ↗ ← All trials in China