Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

This study is currently recruiting participants.
Verified December 2011 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01503905
First received: December 29, 2011
Last updated: January 3, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention
Breast Cancer Nos Premenopausal
Drug: Docetaxel
Drug: epirubicin
Drug: cyclophosphamide
Procedure: Modified radical mastectomy or breast-conserving Surgery
Drug: Docetaxel (post-operative)
Drug: Epirubicin (post-operative)
Drug: Cyclophosphamide (post-operative)
Radiation: Radiation therapy
Drug: Herceptin (post-operative)
Drug: Tamoxifen (post-operative)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:

Primary Outcome Measures:
  • Progression-free survival of patients. [ Time Frame: within 10 years after diagnosis ] [ Designated as safety issue: No ]
  • Overall survival of the patients [ Time Frame: within 10 years after diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The pathological remission rate of patients after neoadjuvant chemotherapy. [ Time Frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy) ] [ Designated as safety issue: No ]
  • The clinical remission rate of patients after neoadjuvant chemotherapy [ Time Frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy) ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: December 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel plus epirubicin Drug: Docetaxel
75mg/m2, iv injection, day1, every 21 days
Drug: epirubicin
80mg/ 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
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.
Active Comparator: docetaxel plus epirubicin plus cyclophosphamide 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patients signed the written informed consent.
  2. The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
  3. The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
  4. The patients have normal cardiac functions by echocardiography.
  5. The patients' ECOG scores are ≤ 0-2.
  6. The age of patient is ≥ 18 years old; And the patients are premenopausal females.
  7. The patients are disposed to practice contraception during the whole trial.
  8. The results of patients' blood tests are as follows:

    • Hb ≥ 90 g/L
    • WBC ≥ 4.0×109/L
    • Plt ≥ 100×109/L
    • Neutrophils ≥ 1.5×109/L
    • ALT and AST ≤ triple of normal upper limit.
    • TBIL ≤ 1.5 times of normal upper limit.
    • Creatinine ≤ 1.25 times of normal upper limit.

Exclusion Criteria:

  1. The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
  2. The patients have active infections that were not suitable for chemotherapy.
  3. The patients have severe non-cancerous diseases.
  4. The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
  5. The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
  6. The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
  7. The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
  8. The patients have allergic history of the chemotherapeutic agents.
  9. The patients have bilateral breast cancers.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503905

Contacts
Contact: Fengxi Su, M.D. 86-20-34071156 fengxisu@vip.163.com

Locations
China, Guangdong
The first People's Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Jie Yang    86-13902805191      
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Siyu Wang    86-18688464714      
The First Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Zhuanghong Wu    86-13602722502      
The Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Renbin Liu    86-13570073298      
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Fengxi Su       fengxisu@vip.163.com   
Nanfang Hospital of Nanfang Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Changsheng Ye    86-13802954097      
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510100
Contact: Pengxi Liu    86-13560333752      
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Lehong Zhang    86-13719150959      
The First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Ningxia Wang       Twnx@Jnu.edu.cn   
Guangdong Women and Children Hospital Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Antai Zhang    86-13925115929      
Guangzhou Women and Children Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Hongmin Ma    86-13922723808      
Guangzhou Army General Hospital Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Chenfang Zhang    86-13889908978      
Zhujiang Hospital of Nanfang Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Aiguo Wu       wagtyz@sina.com   
The first People's Hospital of Guangzhou Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Li Zhao       gdzhaoli@163.com   
Tumor Hospital of Guangzhou Recruiting
Guangzhou, Guangdong, China, 510095
Contact: Hongsheng Li    86-13725111258      
The first Affiliated Hospital of Shenzhen University Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Xianming Wang    86-13500056238      
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: Dongxian Zhou    86-13510363636      
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Study Chair: Fengxi Su, M.D. Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Fengxi Su, Director of Department of Breast Tumor Centre, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01503905     History of Changes
Other Study ID Numbers: BCSCO001
Study First Received: December 29, 2011
Last Updated: January 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
breast cancer
neoadjuvant chemotherapy
amenorrhea

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Trastuzumab
Epirubicin
Tamoxifen
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on April 16, 2014