Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

Stanford is now accepting new patients for this trial. Please contact Amy Isaacson at 650-723-0501 for more information.

Investigator(s):

Intervention(s):

  • procedure : therapeutic conventional surgery
  • radiation : whole breast irradiation

Phase: Phase 2

Eligibility

Ages Eligible For Study:

40 Years - N/A

Inclusion Criteria

1. Age ? 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation. 2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration) 3. Female Gender - Men are excluded from this study. Male breast cancer is a rare event. Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC. 4. Foci of Breast Cancer - Upon clinical exam and pre-operative imaging by both MRI and mammogram, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue. Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS). No more than 2 quadrants with biopsy proven breast cancer. Note: Patient is eligible for study if lesion is not visualized on both imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI). Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only. Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion. 5. Mammogram Imaging - Bilateral mammogram ? 60 days prior to registration 6. MRI Imaging - Bilateral breast MRI ? 60 days prior to registration 7. Staging of Cancer - cN0 or cN1 disease 8. ECOG Performance Status (PS) - 0, 1, or 2. Note: An ECOG PS scale is available on the Cancer Trial Support Unit (CTSU) website. 9. Hemoglobin and Platelet Count - The following laboratory values obtained ? 21 days prior to registration: - Hemoglobin (Hgb) ? 8 g/dL - Peripheral platelet count (PLT) ? 50,000/mm3 10. Pregnancy for Women of Childbearing Potential - Negative urine or serum pregnancy test result ? 7 days prior to registration for women of childbearing potential only. 11. Ability to Complete Questionnaires by themselves or with assistance. 12. Ability to Provide Written Informed Consent 13. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution. Registration

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Contact information

Primary Contact:

Amy Isaacson 650-723-0501

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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