Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer

NCT ID: NCT01969032

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.

Detailed Description

Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated.

One of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 consequent anthracycline-taxane based chemotherapy regimens

Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks

Group Type: EXPERIMENTAL

Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

Intervention Type: DRUG

Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks

Interventions

Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patients, age ≥18 years≤75
• Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast
• Stages Т2-4 N 2-3 M0
• Signed inform consent

Exclusion Criteria

• Previous treatment for this breast cancer
• History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease
• Pregnancy or breast-feeding
• Serious concurrent diseases or conditions that may alter chemotherapy conduction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Russian Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mona Frolova

Senior Research Associate of Department of Clinical Pharmacology and Chemotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Russian Cancer Research Center named after N.N.Blokhin RAMS

Moscow, , Russia

Countries

Russia

Related Links

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

http://www.ncbi.nlm.nih.gov/pubmed

Triple Negative Locally Advanced Breast Cancer, Induction Chemotherapy

Other Identifiers

LATN-2ICR

Identifier Type: -

Identifier Source: org_study_id