Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients - Full Text View

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

Drug Information available for: Cyclophosphamide Tamoxifen Tamoxifen citrate Epirubicin hydrochloride Epirubicin Docetaxel Trastuzumab

U.S. FDA Resources

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.

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:

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

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.
The patients have active infections that were not suitable for chemotherapy.
The patients have severe non-cancerous diseases.
The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
The patients have allergic history of the chemotherapeutic agents.
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 May 16, 2013