A Phase 3 interventional study of Epirubicin plus Cyclophosphamide and Taxanes in Breast Neoplasm, sponsored by Shanghai Jiao Tong University School of Medicine. Active, not recruiting at 27 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment
To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.
This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 786 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
Drug: Epirubicin plus Cyclophosphamide · Drug: Taxanes
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
Drug: Epirubicin plus Cyclophosphamide · Drug: Taxanes plus Carboplatin
Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4
Also known as: EC
Paclitaxel: 80mg/m2, d1, qw\*12 or Docetaxel: 80-100mg/m2,d1,q3w\*4
Paclitaxel: 80mg/m2, d1,d8,d15, q4w\*4 Carboplatin AUC=2, d1,d8,d15, q4w\*4 or Docetaxel: 75mg/m2,d1,q3w\*4 plus Carboplatin AUC=5-6, d1, q3w\*4
Disease-free survival
The time from randomization to local or regional recurrence, distant metastases, other non-breast secondary primary malignancies, contralateral breast cancer, or death due to any cause, whichever occurs first.
Time frame: From time of randomization to 5 years after enrollment.
Distant disease-free survival
The time from randomization to distant metastases, other non-breast secondary primary malignancies, or death due to any cause, whichever occurs first.
Time frame: From time of randomization to 5 years after enrollment.
Overall Survival
The time from randomization to death due to any cause.
Time frame: From time of randomization to 5 years after enrollment.
Incidence of adverse events
To compare the grade 3-5 adverse events among two treatment arms according to the NCI-CTCAE v4.0 criteria.
Time frame: From randomization to four weeks after end of study treatment
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine