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

Phase 2

Completed

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

• Registration Number: NCT01969032
• Lead Sponsor: Russian Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-24
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2 consequent anthracycline-taxane based chemotherapy regimens	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

Primary Outcome Measures

Name	Time	Method
The pathological complete response rate to two consequent induction preoperative chemotherapy regimens	After 18 weeks of induction chemotherapy

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Trial Locations

Locations (1)

Russian Cancer Research Center named after N.N.Blokhin RAMS; 🇷🇺 Moscow, Russian Federation