TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
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.
Eligibility criteria
Qualifiers
Women aged 18-70
Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)
The initial diagnosis condition can be directly operated, without absolute surgical contraindications
No gross or microscopic tumor remains after surgical resection
Disqualifiers
Have a history of invasive cancer
T4 clinical tumors as specified in the Union for International Cancer Control/American Joint Committee on Cancer tumor (UICC/AJCC) Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer
For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer radiotherapy (RT), except for treatments planned under this study condition
Previous treatment with anthracyclines or taxane for any malignant tumor
Trial design
Treatments tested in this trial
- Docetaxel
- Carboplatin
- Epirubicin
- Cyclophosphamide
Treatment groups
1,736 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov