TCb vs EC-T in High Risk ER+/HER2- Breast Cancer

Recruiting Phase 3 Interventional Study
Hormone Receptor Positive HER-2 Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,736 (estimated)
Sponsor
Fudan University · Other
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About This Trial

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Women aged 18-70 2. Unilateral invasive carcinoma confirmed by histology (regardless of pathological type) 3. The initial diagnosis condition can be directly operated, without absolute surgical contraindications 4. No gross or microscopic tumor remains after surgical resectio…
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