- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193115
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Treatment-related toxicities
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Overall response rate
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Doxorubicin
Other Study ID Numbers
- SCRI BRE 69
- 11251 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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