Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments docetaxel cyclophosphamide, cyclophosphamide fluorouracil epirubicin docetaxel, epirubicin cyclophosphamide paclitaxel
Phase phase 3
Sponsor Fudan University
Collaborator Chinese Anti-Cancer Association
Start date June 2010
End date June 2010
Trial size 3200 participants
Trial identifier NCT01314833, Fudan BC Adjuvant CT1

Summary

In recent years, the increasing number of breast cancer patients shows the fact breast cancer is one of the most common cancers in women in China. However, the mortality rate has seen a dramatic decline mainly due to early detection of breast cancer and the use of effective multimodel treatment. Recent studies suggest breast cancers are heterogeneous and recognized by biological subtypes, which lead to markedly different clinical outcome.

Adjuvant chemotherapy is widely used in the treatment for primary breast cancer patients. Different types of breast cancer cells are sensitive to different types of drugs.There is no data to support the information about the adjuvant chemotherapy regimens for different subtypes breast cancer patients, especially for Chinese women.

The investigators hypothesized to confirm the possibility of finding the adjuvant chemotherapy aimed to different subtypes of breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cyclophosphamide 600 mg/m² D1 Docetaxel 75 mg/m² D1 1 cycle = 21 days TC*6 cycles
docetaxel cyclophosphamide FUDANCT1SH
Docetaxel 75 mg/m² D1 Cyclophosphamide600 mg/m² D1 1 cycle = 21 days TC*6
(Experimental)
1st~3rd cycles 5-fluorouracil 500 mg/m2 Epirubicin 90 mg/m2 Cyclophosphamide 500 mg/m2 1 cycle=21 days 4th~6th cycles Docetaxel 100mg/m2 1 cycle=21 days CEF*3-T*3
cyclophosphamide fluorouracil epirubicin docetaxel FUDANCT1SH
1st -3rd Cycle: Fluorouracil 500 mg/m² D1 Epirubicin 100 mg/m² D1 Cyclophosphamide 500 mg/m² D1 1 cycle = 21 days 4th-6th Cycle: Docetaxel 100mg/m² D1 1 cycle = 21 days CEF*3-T*3
(Experimental)
1st~4th cycles: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days 5th-8th cycles: Paclitaxel 80mg/m² D1,D8,D15 1 cycle = 21 days EC*4-P*4
epirubicin cyclophosphamide paclitaxel FUDANCT1SH
1st -4th Cycle: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days 5th-8th Cycle: Paclitaxel 80mg/m² D1,8,15 1 cycle = 21 days EC*4-P*4

Primary Outcomes

Measure
Disease Free Survival
time frame: 5 years

Secondary Outcomes

Measure
Overall Survival
time frame: 10 years
Recurrence Free Survival
time frame: 5 years
Adverse Events
time frame: 5 years

Eligibility Criteria

Female participants from 40 years up to 65 years old.

Inclusion Criteria: 1. Women aged from 40 to 65 years old; 2. Histologically proven invasive unilateral breast cancer (regardless of the type); 3. Initial clinical condition compatible with complete initial resection; 4. No residual macro or microscopic tumor after surgical excision; 5. Beginning of chemotherapeutic treatment no later than day 42 after the initial surgery; 6. Node positive disease (positive sentinel node or positive axillary clearance) (N+) or node negative disease (N-) with the following criteria : SBR II / III and pT > 20 mm; 7. Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):Luminal A, Luminal B,Her-2 overexpressed Hormone receptor negativity is defined as ER<10%, PR<10% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative]. 8. No clinically or radiologically detectable metastases (M0); 9. No peripheral neuropathy > 1; 10. WHO Performance status (ECOG) of 0 or 1; 11. Adequate recovery from recent surgery (at least one week must have elapsed from the time of a minor surgery (excluding breast biopsy); at least three weeks for major surgery); 12. Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl); 13. Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN; 14. Adequate renal function: serum creatinine £ 1.5 ULN; 15. Patients accepting contraception intake during the overall length of treatment if of childbearing potential; 16. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography; 17. Signed written informed consent. Exclusion Criteria: 1. Bilateral breast cancer or patient with controlateral DCIS; 2. Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type; 3. Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer); 4. Triple negative (ER-PR-Her-2-) 5. Any clinically or radiologically suspect and non-explored damage to the controlateral breast; 6. Any chemotherapy, hormonal therapy or radiotherapy before surgery; 7. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive controlateral breast cancer; 8. Patients already included in another therapeutic trial involving an experimental drug; 9. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study; 10. LEVF < 50% (MUGA scan or echocardiography); 11. Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (> 150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to randomization; 12. Known prior severe hypersensitivity reactions to agents containing Cremophor EL; 13. Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 8 weeks after treatment completion; 14. Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase; 15. Women with a positive pregnancy test en enrollment or prior to study drug administration; 16. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; 17. Individual deprived of liberty or placed under the authority of a tutor.

Additional Information

Official title A Randomized Prospective Open Multicentric Phase III Clinical Trial Compared TC, FEC100 Followed by Docetaxel and EC90 Followed by Paclitaxel as Adjuvant Chemotherapy for Chinese Primary Breast Cancer Patients
Description Eligibility Female adults(> 18 years old) are eligible if they had histologically confirmed primary breast cancer. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1, absolute neutrophil count (ANC)> 1500/mm3, hemoglobin > 8.0g/dL, and platelet count > 100,000/mm3, creatinine < 2.5 times the upper limit of normal(ULN)), transaminases < 2.5 times ULN or alkaline phosphatase < 4 times ULN if transaminases was normal, and total bilirubin < 2.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous carcinoma of the skin), any documented distant metastasis and uncontrolled systemic diseases. This study protocol was approved by institutional ethic review boards and conducted according to guidelines for good clinical practice and the Helsinki Declaration. All patients provided written informed consent. Outcome Measures Primary Endpoint:5 year Disease Free Survival(DFS) Second Endpoints:5 year distant disease free survival (DDFS) 5year event free survival (EFS) 5year overall survival (OS)
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Fudan University.