NCT01503905

Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.

Conditions

• Breast Cancer Nos Premenopausal

Interventions

Type	Name	Description
DRUG	Docetaxel	75mg/m2, iv injection, day1, every 21 days
DRUG	epirubicin	80mg/ m2, iv injection, day1, every 21 days
DRUG	cyclophosphamide	500 mg/m2, iv injection, day1, every 21 days
PROCEDURE	Modified radical mastectomy or breast-conserving Surgery	Two weeks after four cycles of neoadjuvant chemotherapy
DRUG	Docetaxel (post-operative)	Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
DRUG	Epirubicin (post-operative)	Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
DRUG	Cyclophosphamide (post-operative)	Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
RADIATION	Radiation therapy	Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
DRUG	Herceptin （post-operative)	Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
DRUG	Tamoxifen (post-operative)	After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.

Timeline

• Start date: 2011-12-01
• Primary completion: 2018-05-01
• Completion: 2021-12-01
• First posted: 2012-01-04
• Last updated: 2016-05-24

Locations

17 sites across 1 country: China