A Phase 3 interventional study of Docetaxel and Carboplatin in Hormone Receptor Positive HER-2 Negative Breast Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Chemotherapy: Intensive intravenous dose of docetaxel (75 mg/m2) + intravenous (IV) carboplatin \[area under the curve (AUC) =5-6\] repeated administration of Q3W for a total of 6 doses
Drug: Docetaxel · Drug: Carboplatin
Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q3W for a total of 4 doses, followed by (IV) docetaxel (80 mg/m2) (Q3W) for 4 doses
Drug: Docetaxel · Drug: Epirubicin · Drug: Cyclophosphamide
Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer
Carboplatin is a deoxyribonucleic acid (DNA) synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.
Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like doxorubicin, exerts its antitumor effects by interference with the synthesis and function of DNA and is most active during the S phase of the cell cycle.
Cyclophosphamide is a nitrogen mustard that exerts its anti-neoplastic effects through alkylation.
invasive disease-free survival (iDFS)
invasive disease-free survival
Time frame: 5 years
distant relapse free survival (DRFS)
distant relapse free survival
Time frame: 5 years
overall survival (OS)
overall survival
Time frame: 5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0
Time frame: through study completion, an average of 1 year
Quality of life measured by EORTC QLQ C30
Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fudan University