While these retrospective data from the modern era described above are encouraging, the safety of BCT in MiBC has not been documented in a prospective fashion. a multicenter study with a uniform and consistent follow-up schedule, defined criteria for recurrence, and strict statistical analysis is necessary to definitively ascertain the safety of breast conservation in the MiBC population. although an ideal trial design would be a randomized study comparing BCT with mastectomy for women with MiBC, this is felt not to be feasible due to increasing appreciation for shared decision making in the breast cancer population. Discussion with american College of Surgeons oncology Group (aCoSoG) breast investigators, patient advocates and the Breast oncology Local Disease (BoLD) taskforce have all indicated that a randomized trial design would not be well supported by patients or physicians. Both patient and surgeon bias would negatively impact timely patient accrual. Therefore, a prospective single arm Phase ii trial to address the incidence of local recurrence in women undergoing breast conservation surgery and radiation therapy for MiBC is proposed.
3.11 Age 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.
3.12 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)
Note: 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.
3.14 Foci of Breast Cancer
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 3 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.
3.15 Bilateral mammogram <= 60 days prior to registration
3.16 MRI Imaging
Bilateral breast MRI <= 60 45 days prior to registration
3.17 cN0 or cN1 disease
3.18 ECOG Performance Status (PS) 0, 1, or 2.
The following laboratory values obtained <= 21 days prior to registration:
* Hemoglobin (Hgb) >= 8 g/dL
* Peripheral platelet count (PLT) >= 50,000/mm3
3.19b Negative serum or urine pregnancy test done <= 7 days prior to registration for women of childbearing potential only.
3.19c Ability to complete questionnaire(s) by themselves or with assistance.
3.19d Provide informed written consent.
3.19e Willing to Return to Enrolling Institution
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.
3.19f Willing to Provide Tissue Samples
Willing to provide tissue samples for correlative research purposes (see Sections 6.0 and 14.0) Note: Patients are eligible for study if there was insufficient tissue obtained for the site to be able to submit tissue. Sites must document this in writing and submit a copy with the required operative and pathology reports.