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

Primary Purpose

Triple Negative Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel plus carboplatin

Paclitaxel and epirubicin

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple Negative Breast Cancer, Neoadjuvant chemotherapy, Platinum

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Cancer institute &Hospital，Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

The control arm receive the paclitaxel plus epirubicin

the experimental arm which receive the paclitaxel combined with carboplatin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01276769

First Posted

December 10, 2010

Last Updated

November 15, 2011

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01276769

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer, Neoadjuvant chemotherapy, Platinum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

The control arm receive the paclitaxel plus epirubicin

Arm Title

Arm Type

Experimental

Arm Description

the experimental arm which receive the paclitaxel combined with carboplatin

Intervention Type

Drug

Intervention Name(s)

Paclitaxel plus carboplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel and epirubicin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

One week after the surgery

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ZHANG Pin, BD

Phone

+861087788120

zhang_pin@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

YIN Yi, BD

elovf1@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ZHANG Pin, BD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer institute &Hospital，Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ZHANG Pin, BD

Phone

+861087788120

zhang_pin@163.com

First Name & Middle Initial & Last Name & Degree

YIN Yi, BD

elovf1@163.com

First Name & Middle Initial & Last Name & Degree

ZHANG Pin, BD

12. IPD Sharing Statement

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

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