Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

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

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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  lead OTHER

Principal Investigators

• Fengxi Su, M.D. · Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2018-05-31

Completion

2021-12-31

Countries

• China

Study Locations