Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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 | Breast Cancer |
| Intervention | Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide |
| Phase | Phase 2 |
| Sponsor | SCRI Development Innovations, LLC |
| Responsible Party | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier | NCT00193115 |
| First Received | September 12, 2005 |
| Last Updated | August 3, 2010 |
| Last verified | January 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 12, 2005 |
|---|---|
| Last Updated Date | August 3, 2010 |
| Start Date | March 2004 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures | Treatment-related toxicities |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer |
|---|---|
| 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 |
| 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 Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Cancer |
| Intervention | Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 32 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | June 2005 |
| 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00193115 |
|---|---|
| Other Study ID Numbers | SCRI BRE 69 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | SCRI Development Innovations, LLC |
| Study Sponsor | SCRI Development Innovations, LLC |
| Collaborators | Aventis Pharmaceuticals |
| Investigators | Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC |
| Verification Date | January 2009 |