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

• Sponsor: SCRI Development Innovations, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT00193115
• Collaborator: Aventis Pharmaceuticals (Industry)
• Enrollment: 32
• Duration (Months): 58.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jan 1, 2009

Outcome Measures

Primary Outcome Measures

1. Treatment-related toxicities []

Secondary Outcome Measures

1. Overall response rate []

2. Overall survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• SCRI Development Innovations, LLC
• Aventis Pharmaceuticals

Investigators

• Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Published article in Clinical Breast Cancer

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00193115
• Other Study ID Numbers: SCRI BRE 69; 11251
• First Posted: Sep 19, 2005
• Last Update Posted: Aug 4, 2010
• Last Verified: Jan 1, 2009

• Additional relevant MeSH terms: Breast Neoplasms; Cyclophosphamide; Docetaxel; Doxorubicin

Study Results

No Results Posted as of Aug 4, 2010