Status:
AVAILABLE
Efficacy and Safety Study of Neoadjuvant Chemotherapy for Local Advanced Triple Negative Breast Cancer Patients
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Chinese Anti-Cancer Association
Conditions:
Triple Negative Local Advanced Breast Cancer
Eligibility:
FEMALE
18-65 years
Brief Summary
The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is based on three s...
Detailed Description
Eligibilty Female adults(\>18 years old) were eligible if they had histologically or cytologically confirmed stage IIIb or IIIc TNLABC that had not been treated with any systemic treatment. Patients a...
Eligibility Criteria
Inclusion
- Women aged from 18 to 65 years;
- Histologically or cytologically proven invasive unilateral breast cancer (regardless of the type);
- Initial clinical condition compatible with complete initial resection;
- No residual macro or microscopic tumor after surgical excision;
- Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):
- Triple Negative(ER-PR-Her-2-) Hormone receptor negativity is defined as ER\<10%, PR\<10% (IHC), HER2 negativity is defined as IHC 0-1+, or \[IHC 2+ and FISH or CISH negative\].
- No clinically or radiologically detectable metastases (M0);
- No peripheral neuropathy \> 1;
- WHO Performance status (ECOG) of 0 or 1;
- Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin \> 9 g/dl);
- Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN;
- Adequate renal function: serum creatinine £ 1.5 ULN;
- Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
- Adequate cardiac function, LEVF value \> 50% by Muga scan or echocardiography;
- Signed written informed consent.
Exclusion
- Bilateral breast cancer or patient with controlateral DCIS;
- Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type;
- Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
- Luminal A, Luminal B and Her-2 overexpression
- Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
- Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive controlateral breast cancer;
- Patients already included in another therapeutic trial involving an experimental drug;
- Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
- LEVF \< 50% (MUGA scan or echocardiography);
- 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;
- Known prior severe hypersensitivity reactions to agents in this study
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01216124
Last Update
October 7 2010
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