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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00278109 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain.
PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy |
| Estimated Enrollment: | 42 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for approximately 10 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 39 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and eosin (H&E) staining
Primary tumor ≤ 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2, pathologic N0-N1, M0)
Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy within the past 14 weeks
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent hormonal therapy except the following:
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Richard C. Zellars, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Richard C. Zellars ) |
| Study ID Numbers: | CDR0000446085, JHOC-J0381, JHOC-04032201 |
| Study First Received: | January 16, 2006 |
| Last Updated: | February 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00278109 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer |
|
Anti-Bacterial Agents Immunologic Factors Skin Diseases Adjuvants, Immunologic Breast Neoplasms Antineoplastic Agents, Alkylating |
Cyclophosphamide Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Doxorubicin Breast Diseases |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
