Ensayos clínicos

Registration 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 Exclusion Criteria:

1. Pregnancy, Nursing and Requirement for Contraception Any of the following because this study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects:
   • Pregnant women
   • Nursing women
   • Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
2. Size of Single Focus of Disease - Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1centimeter of the index lesion.
3. Prior Staging Procedure - Surgical axillary staging procedure prior to study entry. Note: FNA or core needle biopsy of axillary node is permitted.
4. Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease
5. Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]
6. Staging of Cancer - cNX, cN2, or cN3 disease
7. Breast Implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible.
8. Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).
9. Uncontrolled Intercurrent Illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
10. Bilateral Breast Cancer Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).
11. Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to registration.
12. Chemotherapy or Endocrine Therapy Prior to Surgery - Neoadjuvant chemotherapy or neoadjuvant endocrine therapy (in other words, no chemotherapy or endocrine therapy prior to surgery) for this cancer.
13. Partial Breast Radiation - Planned partial breast radiation.
14. Investigational Agents - Administration of any investigational agent ≤ 30 days prior to registration.
15. Known BRCA Mutations - Patients with known BRCA mutations.
16. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

Exceptions:

Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.