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

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

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.

Study Overview

• Status: Unknown
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Paclitaxel and epirubicin; Drug: Paclitaxel plus carboplatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer institute &Hospital，Chinese Academy of Medical Sciences
      • Contact: YIN Yi, BD; Email: elovf1@163.com
      • Contact: ZHANG Pin, BD; Phone Number: +861087788120; Email: zhang_pin@163.com
      • Principal Investigator: ZHANG Pin, BD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ET; The control arm receive the paclitaxel plus epirubicin	Drug: Paclitaxel and epirubicin; Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v. 1 cycle = 21days 2-6cycles
Experimental: PC; the experimental arm which receive the paclitaxel combined with carboplatin	Drug: Paclitaxel plus carboplatin; Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v. 1 cycle = 21days 2-6cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: ZHANG Pin, BD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: December 10, 2010
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 15, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Platinum; Triple Negative Breast Cancer; Neoadjuvant chemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Carboplatin; Paclitaxel; Epirubicin; Albumin-Bound Paclitaxel
• Other Study ID Numbers: LC2010A03