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

Russian Academy of Medical Sciences (RAMS)

Status and phase: Completed; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01969032

LATN-2ICR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

2 consequent anthracycline-taxane based chemotherapy regimens

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine