Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
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- STATUS
- Recruiting
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- End date
- Dec 5, 2027
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- participants needed
- 286
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- sponsor
- Chinese Academy of Medical Sciences
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.
Description
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
Details
| Condition | Breast Cancer, Breast Cancer, Breast Cancer - HER2 Positive, Chronic Shoulder Pain |
|---|---|
| Age | 18-75 years |
| Treatment | Cyclophosphamide, Epirubicin or Pirarubicin |
| Clinical Study Identifier | NCT04437160 |
| Sponsor | Chinese Academy of Medical Sciences |
| Last Modified on | 19 February 2024 |
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