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

Triple Negative Breast Cancer Clinical Trial

Official title:

Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01276769
• Other study ID #: LC2010A03
• Status: Recruiting
• Phase: Phase 2
• First received: December 10, 2010
• Last updated: November 15, 2011
• Start date: January 2008
• Est. completion date: July 2012

Study information

• Verified date: November 2011
• Source: Chinese Academy of Medical Sciences
• Contact: ZHANG Pin, BD
• Phone: +861087788120
• Email: zhang_pin[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple negative breast cancer in both pathological features and clinical prognosis,and there is no standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs is considered as a strong arrangement and therefore,is common used in Triple negative breast cancer patients because of its poor prognosis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Women aged from 18 to 70 years;

• WHO Performance status (ECOG) of 0 or 1

• Core biopsy histologically proven ?a-?c 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:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Cancer institute &Hospital,Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Cancer Institute and Hospital, Chinese Academy of Medical Sciences