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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel plus epirubicin | Active Comparator |
| |
| docetaxel plus epirubicin plus cyclophosphamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75mg/m2, iv injection, day1, every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival of patients. | within 10 years after diagnosis | |
| Overall survival of the patients | within 10 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| The pathological remission rate of patients after neoadjuvant chemotherapy. | within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy) | |
| The clinical remission rate of patients after neoadjuvant chemotherapy | within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy) |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengxi Su, M.D. | Contact | 86-20-34071156 | fengxisu@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengxi Su, M.D. | Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first People's Hospital of Foshan | Recruiting | Foshan | Guangdong | 528000 | China |
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| epirubicin | Drug | 80mg/ m2, iv injection, day1, every 21 days |
|
| cyclophosphamide | Drug | 500 mg/m2, iv injection, day1, every 21 days |
|
| Modified radical mastectomy or breast-conserving Surgery | Procedure | Two weeks after four cycles of neoadjuvant chemotherapy |
|
| Docetaxel (post-operative) | Drug | Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally. |
|
| Epirubicin (post-operative) | Drug | Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally |
|
| Cyclophosphamide (post-operative) | Drug | Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally. |
|
| Radiation therapy | Radiation | Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline. |
|
| Herceptin (post-operative) | Drug | 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) | Drug | After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive. |
|
| Guangdong Women and Children Hospital | Recruiting | Guangzhou | Guangdong | 510010 | China |
|
| Guangzhou Army General Hospital | Recruiting | Guangzhou | Guangdong | 510010 | China |
|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The First Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Tumor Hospital of Guangzhou | Recruiting | Guangzhou | Guangdong | 510095 | China |
|
| The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510100 | China |
|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
|
| Guangzhou Women and Children Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
|
| The first People's Hospital of Guangzhou | Recruiting | Guangzhou | Guangdong | 510180 | China |
|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
|
| Zhujiang Hospital of Nanfang Medical University | Recruiting | Guangzhou | Guangdong | 510282 | China |
|
| Nanfang Hospital of Nanfang Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
|
| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | 510630 | China |
|
| The Third Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | 518020 | China |
|
| The first Affiliated Hospital of Shenzhen University | Recruiting | Shenzhen | Guangdong | 518035 | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D015411 | Mastectomy, Modified Radical |
| D015412 | Mastectomy, Segmental |
| D011184 | Postoperative Period |
| D011878 | Radiotherapy |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D015409 | Mastectomy, Radical |
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D059035 | Perioperative Period |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D013812 | Therapeutics |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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