Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer

SCRI Development Innovations, LLC0 sites32 target enrollmentMarch 2004

ConditionsBreast Cancer

DrugsDocetaxel Doxorubicin Cyclophosphamide

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: SCRI Development Innovations, LLC
Enrollment: 32
Primary Endpoint: Treatment-related toxicities
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

Detailed Description

Upon determination of eligibility, patients will receive: Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

January 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

SCRI Development Innovations, LLC

Eligibility Criteria

Inclusion Criteria

•To be included in this study, you must meet the following criteria:
•Histologically proven breast cancer
•Females, age greater than 18 years
•Ability to perform activites of daily living with minimal assistance
•Normal cardiac function
•Adequate bone marrow, liver and kidney
•Signed informed consent prior to beginning specific protocol procedures

Exclusion Criteria

•You cannot participate in this study if any of the following apply to you:
•Prior systemic anticancer therapy for breast cancer
•Prior anthracycline or taxane based chemotherapy for any malignancy
•Pregnant or breast-feeding women.
•Pre-existing moderate to severe motor or sensory neurotoxicity
•Other serious illness or medical condition
•Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.