Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003)

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2006
INTERVENTION: 5‐fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel (T) 5‐fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel, capecitabine (TX) CONDITION: Operable breast cancer PRIMARY OUTCOME: Pathologic response (pCR rate) SECONDARY OUTCOME: Toxicity; Clinical response; Frequency of breast conservation surgery; Frequency of axillary lymph node conservation surgery ; Disease‐free survival; Overall survival INCLUSION CRITERIA: T1C‐3 N0 M0(>1cm) / T1‐3 N1 M0} No prior treatment for breast cancer ECOG performance status (PS) 0‐1 Adequate organ funtion signed a Patients Informed Consent Form
Epistemonikos ID: d44a8753b338a66f710fa3475209e9e7228f29b0
First added on: Aug 21, 2024