Comparing Radiation and Endocrine Therapy with Endocrine Therapy (Tamoxifen, for stage i breast cancer

Exclusion

• −Psychiatric or addictive disorders or other conditions that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
• −• Definitive clinical or radiologic evidence of metastatic disease.
• −pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
• −Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
• −Patient had a mastectomy.
• −Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
• −Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
• −Non-epithelial breast malignancies such as sarcoma or lymphoma.
• −Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
• −Paget's disease of the nipple.
• −Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
• −Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
• −Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)
• −History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1.
• −Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention.
• −\*\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if:
• −the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND
• −the patient had not initiated endocrine therapy prior to core biopsy tissue collection.
• −Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
• −Prior breast or thoracic RT for any condition.
• −Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
• −Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
• −Use of any investigational product within 30 days prior to pre-entry/Step 1.
• −Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.)
• −Treatment plan that includes regional nodal irradiation.
• −Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1.
• −\*\*\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1).