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

Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115478
    • Russian Cancer Research Center named after N.N.Blokhin RAMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The pathological complete response rate to two consequent induction preoperative chemotherapy regimens	After 18 weeks of induction chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	3 years

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens	After 18 weeks os induction chemotherapy

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences

Publications and helpful links

Helpful Links

• Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine
• Triple Negative Locally Advanced Breast Cancer, Induction Chemotherapy

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (ESTIMATE): October 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Carboplatin; Paclitaxel; Capecitabine; Doxorubicin
• Other Study ID Numbers: LATN-2ICR