Comparison Study of Neoadjuvant Paclitaxel Plus Carboplatin/Epirubicin Treatment in Triple-negative Breast Cancer
NCT ID: NCT01276769
Last Updated: 2011-11-16
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
PHASE2
80 participants
INTERVENTIONAL
2008-01-31
2012-07-31
Brief Summary
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Detailed Description
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According to the results of some retrospective studies, platinum-based chemotherapy regimens showed a promising sensitive to Triple negative breast cancer patients compared with regimens without platinum.
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ET
The control arm receive the paclitaxel plus epirubicin
Paclitaxel and epirubicin
Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v.
1 cycle = 21days
2-6cycles
PC
the experimental arm which receive the paclitaxel combined with carboplatin
Paclitaxel plus carboplatin
Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v.
1 cycle = 21days 2-6cycles
Interventions
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Paclitaxel plus carboplatin
Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v.
1 cycle = 21days 2-6cycles
Paclitaxel and epirubicin
Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v.
1 cycle = 21days
2-6cycles
Eligibility Criteria
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Inclusion Criteria
* WHO Performance status (ECOG) of 0 or 1
* Core biopsy histologically proven Ⅱa-Ⅲc phase breast cancer (regardless of the type);
* Immunohistochemisty（IHC）：ER-，PR-，CerB2-；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 \[IHC 2+ and FISH or CISH negative\]；
* 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;
* Adequate cardiac function, LEVF value \> 50% by Muga scan or echocardiography，and electrocardiogram doe not show specific abnormality；
* Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
* Signed written informed consent.
Exclusion Criteria
* ER+ or PR+ or Her-2 overexpression
* Any chemotherapy, hormonal therapy or radiotherapy before
* Previous cancer in the preceding 10 years;
* 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 chemotherapy;
* Known prior severe hypersensitivity reactions to agents that will be received;
* Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase;
* Women with a positive pregnancy test en enrollment or prior to study drug administration;
* 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;
* Individual deprived of liberty or placed under the authority of a tutor.
18 Years
70 Years
FEMALE
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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ZHANG Pin
Medicine Oncology Department
Principal Investigators
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ZHANG Pin, BD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer institute &Hospital，Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC2010A03
Identifier Type: -
Identifier Source: org_study_id