Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer
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
2 other identifiers
interventional
32
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Mar 2004
Typical duration for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedAugust 4, 2010
January 1, 2009
1.3 years
September 12, 2005
August 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-related toxicities
Secondary Outcomes (2)
Overall response rate
Overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Aventis Pharmaceuticalscollaborator
Related Publications (1)
Yardley DA, Burris HA 3rd, Farley CP, Barton JH, Peacock NW, Spigel DR, Greco FA, Hainsworth JD. A phase II feasibility trial of dose-dense docetaxel followed by doxorubicin/cyclophosphamide as adjuvant or neoadjuvant treatment for women with node-positive or high-risk node-negative breast cancer. Clin Breast Cancer. 2008 Jun;8(3):242-8. doi: 10.3816/CBC.2008.n.027.
PMID: 18650154RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise A. Yardley, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
March 1, 2004
Primary Completion
June 1, 2005
Study Completion
January 1, 2009
Last Updated
August 4, 2010
Record last verified: 2009-01