Comparison Study of Neoadjuvant Paclitaxel Plus Carboplatin/Epirubicin Treatment in Triple-negative Breast Cancer

NCT01276769 | Unknown Phase 2 DMC

• 1 other identifier: LC2010A03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer; Neoadjuvant chemotherapy; Platinum

Outcome Measures

Primary Outcomes (1)

• Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery

  After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ，and compare the pCR（pathological complete remission）rates of two amrs

  One week after the surgery

Secondary Outcomes (1)

• follow-up the patient every 3-6 months to obtain the 3 year-DFS(disease free survival ) and OS(overall survival )

  we follow up the patients every 6 month ,up to 3 years

Study Arms (2)

ET

ACTIVE COMPARATOR

The control arm receive the paclitaxel plus epirubicin

Drug: Paclitaxel and epirubicin

PC

EXPERIMENTAL

the experimental arm which receive the paclitaxel combined with carboplatin

Drug: Paclitaxel plus carboplatin

Interventions

Paclitaxel plus carboplatin DRUG

Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v. 1 cycle = 21days 2-6cycles

PC

Paclitaxel and epirubicin DRUG

Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v. 1 cycle = 21days 2-6cycles

ET

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged from 18 to 70 years;
• 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.

You may not qualify if:

• Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer institute &Hospital，Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Paclitaxel; Carboplatin; Epirubicin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• ZHANG Pin, BD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHANG Pin, BD

CONTACT

+861087788120; zhang_pin@sina.com

YIN Yi, BD

CONTACT

elovf1@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Oncology Department

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: January 13, 2011
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

CN (1)