Status:
RECRUITING
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Triple Negative Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT04437160
Start Date
February 1 2020
End Date
December 1 2027
Last Update
June 18 2020
Active Locations (1)
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1
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, China, 100021