A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast

PHASE1RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Breast Cancer
Interventions
DRUG

Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate

Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30\~60 days before surgery:cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.

DRUG

cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)

Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30\~60 days before surgery:cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.

DRUG

Placebo

Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.

Trial Locations (3)

130033

RECRUITING

China-Japan Union Hospital, Jilin University, Changchun

200072

RECRUITING

Shanghai 10th People's Hospital, Tongji University School of Medicine, Shanghai

341000

RECRUITING

Ganzhou City People's Hospital, Ganzhou

All Listed Sponsors
collaborator

Shanghai 10th People's Hospital

OTHER

collaborator

China-Japan Union Hospital, Jilin University

OTHER

collaborator

Ganzhou City People's Hospital

OTHER

lead

Shanghai Jiao Tong University School of Medicine

OTHER