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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Chinese Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
ZHANG Pin, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01276769
First received: December 10, 2010
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Triple Negative Breast Cancer
Drug: Paclitaxel plus carboplatin
Drug: Paclitaxel and epirubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery [ Time Frame: One week after the surgery ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • follow-up the patient every 3-6 months to obtain the 3 year-DFS(disease free survival ) and OS(overall survival ) [ Time Frame: we follow up the patients every 6 month ,up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276769

Contacts
Contact: ZHANG Pin, BD +861087788120 zhang_pin@sina.com
Contact: YIN Yi, BD elovf1@163.com

Locations
China, Beijing
Cancer institute &Hospital,Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: ZHANG Pin, BD    +861087788120    zhang_pin@163.com   
Contact: YIN Yi, BD       elovf1@163.com   
Principal Investigator: ZHANG Pin, BD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: ZHANG Pin, BD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: ZHANG Pin, Medicine Oncology Department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01276769     History of Changes
Other Study ID Numbers: LC2010A03
Study First Received: December 10, 2010
Last Updated: November 15, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
Triple Negative Breast Cancer
Neoadjuvant chemotherapy
Platinum

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Epirubicin
Paclitaxel
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014