Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00193115
• Lead Sponsor: SCRI Development Innovations, LLC

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2010-08-03
• Last Update Posted: 2010-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment-related toxicities

Secondary Outcome Measures

Name	Time	Method
Overall response rate
Overall survival