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The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy Clinical research trials and The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy. The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy clinical trial. Human subjects often receive the most effective healthcare possible for their The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy  The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy
The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy
For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.
Details: Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Female patients of any age with a dominant breast mass meeting the following requirements are eligible for this protocol: On clinical evaluation the tumor must be confined to the breast and axillary lymph nodes (stage I and II). Biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin. Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI. Patient must be mentally competent to understand and give informed consent for the protocol. EXCLUSION CRITERIA: Patients will be excluded from this protocol for the following reasons: Advanced local disease or distant metastases (stage III and IV); Inflammatory cancer; Chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which may render the patient a poor operative risk; History of another cancer other than skin cancer (non-melanoma); Concurrent pregnancy or lactation; Non-palpable lesions manifested only by nipple discharge or skin rash (Paget's disease); Previous therapy to the breast cancer other than excisional biopsy; Multiple masses or multiple suspicious areas on mammogram unless all but one are proven histologically benign; and Bilateral breast carcinoma, either invasive or in-situ.
Total Enrollment: 520
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 790111; 79-C-0111
Study Start Date: September 13, 1979
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026845
Other Breast Cancer Studies:
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2. Allogeneic (Donor) Bone Marrow Transplant to Treat Breast Cancer
3. Treatment with Zometa in patients with breast cancer, multiple myeloma, and prostate cancer with cancer related bone lesions
4. Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients with Chest Wall Recurrence or Stage IV Disease with Locally Advanced Breast Cancer
5. Combination Chemotherapy (FLAC) Combined with Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer
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The Treatment of Stage I and II Breast Cancer with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy
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