Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Treatment-related toxicities
- Overall response rate
- Overall survival
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2004 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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 More Information
Additional Information:
Publications:
| Responsible Party: | Denise A. Yardley, M.D., Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193115 History of Changes |
| Other Study ID Numbers: | SCRI BRE 69, 11251 |
| Study First Received: | September 12, 2005 |
| Last Updated: | August 3, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Doxorubicin Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on June 17, 2013