Back to resultsNeoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
Primary Purpose
Breast Cancer Nos Premenopausal
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Docetaxel
epirubicin
cyclophosphamide
Modified radical mastectomy or breast-conserving Surgery
Docetaxel (post-operative)
Epirubicin (post-operative)
Cyclophosphamide (post-operative)
Radiation therapy
Herceptin （post-operative)
Tamoxifen (post-operative)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Nos Premenopausal focused on measuring breast cancer, neoadjuvant chemotherapy, amenorrhea
Eligibility 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.
Sites / Locations
- The first People's Hospital of FoshanRecruiting
- Guangdong Women and Children HospitalRecruiting
- Guangzhou Army General HospitalRecruiting
- Sun Yat-Sen University Cancer CenterRecruiting
- The First Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
- Tumor Hospital of GuangzhouRecruiting
- The Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineRecruiting
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
- Guangzhou Women and Children HospitalRecruiting
- The first People's Hospital of GuangzhouRecruiting
- The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- Zhujiang Hospital of Nanfang Medical UniversityRecruiting
- Nanfang Hospital of Nanfang Medical UniversityRecruiting
- The First Affiliated Hospital of Jinan UniversityRecruiting
- The Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
- Shenzhen People's HospitalRecruiting
- The first Affiliated Hospital of Shenzhen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Docetaxel plus epirubicin
docetaxel plus epirubicin plus cyclophosphamide
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival of patients.
Overall survival of the patients
Secondary Outcome Measures
The pathological remission rate of patients after neoadjuvant chemotherapy.
The clinical remission rate of patients after neoadjuvant chemotherapy
Full Information
NCT ID
NCT01503905
First Posted
December 29, 2011
Last Updated
May 23, 2016
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01503905
Brief Title
Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Nos Premenopausal
Keywords
breast cancer, neoadjuvant chemotherapy, amenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel plus epirubicin
Arm Type
Active Comparator
Arm Title
docetaxel plus epirubicin plus cyclophosphamide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75mg/m2, iv injection, day1, every 21 days
Intervention Type
Drug
Intervention Name(s)
epirubicin
Intervention Description
80mg/ m2, iv injection, day1, every 21 days
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
500 mg/m2, iv injection, day1, every 21 days
Intervention Type
Procedure
Intervention Name(s)
Modified radical mastectomy or breast-conserving Surgery
Intervention Description
Two weeks after four cycles of neoadjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel (post-operative)
Intervention Description
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Intervention Type
Drug
Intervention Name(s)
Epirubicin (post-operative)
Intervention Description
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (post-operative)
Intervention Description
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
Intervention Type
Drug
Intervention Name(s)
Herceptin （post-operative)
Intervention Description
Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen (post-operative)
Intervention Description
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
Primary Outcome Measure Information:
Title
Progression-free survival of patients.
Time Frame
within 10 years after diagnosis
Title
Overall survival of the patients
Time Frame
within 10 years after diagnosis
Secondary Outcome Measure Information:
Title
The pathological remission rate of patients after neoadjuvant chemotherapy.
Time Frame
within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
Title
The clinical remission rate of patients after neoadjuvant chemotherapy
Time Frame
within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengxi Su, M.D.
Phone
86-20-34071156
Email
fengxisu@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengxi Su, M.D.
Organizational Affiliation
Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The first People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yang
Phone
86-13902805191
Facility Name
Guangdong Women and Children Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antai Zhang
Phone
86-13925115929
Facility Name
Guangzhou Army General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenfang Zhang
Phone
86-13889908978
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siyu Wang
Phone
86-18688464714
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuanghong Wu
Phone
86-13602722502
Facility Name
Tumor Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsheng Li
Phone
86-13725111258
Facility Name
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengxi Liu
Phone
86-13560333752
Facility Name
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengxi Su
Email
fengxisu@vip.163.com
Facility Name
Guangzhou Women and Children Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmin Ma
Phone
86-13922723808
Facility Name
The first People's Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhao
Email
gdzhaoli@163.com
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lehong Zhang
Phone
86-13719150959
Facility Name
Zhujiang Hospital of Nanfang Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiguo Wu
Email
wagtyz@sina.com
Facility Name
Nanfang Hospital of Nanfang Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changsheng Ye
Phone
86-13802954097
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ningxia Wang
Email
Twnx@Jnu.edu.cn
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renbin Liu
Phone
86-13570073298
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongxian Zhou
Phone
86-13510363636
Facility Name
The first Affiliated Hospital of Shenzhen University
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianming Wang
Phone
86-13500056238
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
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