Actively Recruiting
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
Led by Chinese Academy of Medical Sciences · Updated on 2020-06-18
286
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed invasive breast adenocarcinoma
- Triple negative breast cancer (ER < 10%, PgR < 10%, HER2 negative)
- Clinical stage T1-4, N0-3, M0, eligible for neoadjuvant chemotherapy
- Completed at least 4 cycles of platinum and taxane neoadjuvant chemotherapy without tumor progression
- Underwent surgery to remove tumor and lymph nodes after neoadjuvant chemotherapy
- Residual invasive disease ≥1 cm in breast and/or positive axillary lymph nodes after chemotherapy
- ECOG performance status 0-1
- No severe heart, lung, liver, or kidney disease
- Adequate blood counts and organ function
- Randomization within 6 weeks after definitive breast surgery
You will not qualify if you...
- Previous neoadjuvant chemotherapy with anthracycline or drugs other than platinum and taxanes
- Neoadjuvant chemotherapy using platinum or taxanes alone
- Received other adjuvant therapy
- Evidence of distant metastases before randomization
- Unsuitable for anthracycline treatment as judged by investigators
- History of other cancers except carcinoma in situ
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
P
Pin ZHANG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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