Skip to main content
OpenTrials
Completed

NCT Number: NCT01969032

Induction Preoperative Chemotherapy 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Moscow, 115478, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine

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

Primary outcomes

  1. The pathological complete response rate to two consequent induction preoperative chemotherapy regimens

    Time frame: After 18 weeks of induction chemotherapy

Secondary outcomes

  1. Disease-free survival

    Time frame: 3 years

Other outcomes

  1. Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens

    Time frame: After 18 weeks os induction chemotherapy

Sponsors and collaborators

Lead sponsor

Russian Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2013
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.