Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
NCT ID: NCT01503905
Last Updated: 2016-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2011-12-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel plus epirubicin
Docetaxel
75mg/m2, iv injection, day1, every 21 days
epirubicin
80mg/ m2, iv injection, day1, every 21 days
Modified radical mastectomy or breast-conserving Surgery
Two weeks after four cycles of neoadjuvant chemotherapy
Docetaxel (post-operative)
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Epirubicin (post-operative)
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Radiation therapy
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
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.
Tamoxifen (post-operative)
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
docetaxel plus epirubicin plus cyclophosphamide
Docetaxel
75mg/m2, iv injection, day1, every 21 days
epirubicin
80mg/ m2, iv injection, day1, every 21 days
cyclophosphamide
500 mg/m2, iv injection, day1, every 21 days
Modified radical mastectomy or breast-conserving Surgery
Two weeks after four cycles of neoadjuvant chemotherapy
Docetaxel (post-operative)
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Epirubicin (post-operative)
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Cyclophosphamide (post-operative)
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Radiation therapy
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
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.
Tamoxifen (post-operative)
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
Interventions
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Docetaxel
75mg/m2, iv injection, day1, every 21 days
epirubicin
80mg/ m2, iv injection, day1, every 21 days
cyclophosphamide
500 mg/m2, iv injection, day1, every 21 days
Modified radical mastectomy or breast-conserving Surgery
Two weeks after four cycles of neoadjuvant chemotherapy
Docetaxel (post-operative)
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Epirubicin (post-operative)
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Cyclophosphamide (post-operative)
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Radiation therapy
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
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.
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 Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Fengxi Su
Director of Department of Breast Tumor Centre
Principal Investigators
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Fengxi Su, M.D.
Role: STUDY_CHAIR
Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
Locations
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The first People's Hospital of Foshan
Foshan, Guangdong, China
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Guangzhou Army General Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Tumor Hospital of Guangzhou
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou Women and Children Hospital
Guangzhou, Guangdong, China
The first People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital of Nanfang Medical University
Guangzhou, Guangdong, China
Nanfang Hospital of Nanfang Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The first Affiliated Hospital of Shenzhen University
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jie Yang
Role: primary
Antai Zhang
Role: primary
Chenfang Zhang
Role: primary
Siyu Wang
Role: primary
Zhuanghong Wu
Role: primary
Hongsheng Li
Role: primary
Pengxi Liu
Role: primary
Hongmin Ma
Role: primary
Lehong Zhang
Role: primary
Changsheng Ye
Role: primary
Renbin Liu
Role: primary
Dongxian Zhou
Role: primary
Xianming Wang
Role: primary
Other Identifiers
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BCSCO001
Identifier Type: -
Identifier Source: org_study_id
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