Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer
Currently the standard of care is to treat early stage invasive breast cancer or ductal
 carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as
 "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a
 lumpectomy is to the whole breast.

 However the investigators do not know if the whole breast needs to be receive radiation to
 better control your cancer or only a more limited area of the breast surrounding the tumor.
 The purpose of this study is to see the side effects of delivering partial breast irradiation
 (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the
 area of the breast where the cancer was removed. Another purpose of this study is to look
 long term at the rate at which cancer comes back in the same breast after PBI.

 WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial
 breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The
 investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a
 day, five days a week, for 2 weeks.

 In this study the investigators will learn about the good and bad effects of PBI radiation
 therapy. In this study, the investigators will also learn about how the breast looks after
 surgery and radiation therapy.
Inclusion Criteria:

 -  Female

 -  Age ≥ 18 years

 -  Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS
 measuring <2 cm on pathology and/or mammogram that is histologically confirmed at
 MSKCC

 -  Histologically negative tumor margin 2 mm or more from any inked edges or no tumor in
 a re-excision specimen or final shaved specimen

 -  ECOG Performance Status of 0 or 1

 -  Granulocytes ≥1,500/μl and platelet count must be ≥100,000/μl at the beginning of
 therapy for patients treated with adjuvant chemotherapy

 -  Women >70 years or older with T1 invasive ductal carcinoma who are estrogen-receptor
 positive (ER+) with clinically negative axillary nodes and do not undergo surgical
 lymph node evaluation are eligible if patient will take hormonal therapy.

 -  Patients with T1N0(i+) tumors on sentinel lymph node mapping or dissection (i.e., if
 tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by
 immunohistochemistry or hematoxylin and eosin staining) will also be eligible.

 -  Clips must be placed in the lumpectomy cavity at the time of final excision in order
 to aid in the delineation of the tumor cavity at the time of simulation and radiation
 delivery.

 Exclusion Criteria:

 -  Patients with distant metastasis.

 -  Patients who are pregnant or breastfeeding.

 -  Patients with diffuse (>1 quadrant or >5 cm) suspicious microcalcifications.

 -  Prior radiation therapy to the ipsilateral or contralateral breast or thorax.

 -  Histological evidence of lymphovascular invasion (LVI). Cases termed focally
 suspicious for LVI but where no definitive LVI is found are eligible.

 -  Histologic evidence of EIC, defined as the presence of intraductal carcinoma both
 within the primary infiltrating ductal tumor (comprising at least 25% of the tumor
 area) and intraductal carcinoma present clearly beyond the edges of the invasive
 tumor, or as a predominantly intraductal tumor with one or more areas of focal
 invasion.

 -  Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests
 in order to enroll on the study. However, in the event a patient is tested and is
 found to be a mutation carrier, she would be excluded from the study. It would be an
 extremely rare/unlikely scenario for patients to be discovered BRCA positive after the
 completion of PBI, as all patients with risk factors for BRCA mutations (positive
 family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu negative receptor status)
 are usually tested prior to radiation. Should such a situation exist, these patients
 will not receive additional RT and the patient will be replaced in the trial.

 -  History of cosmetic or reconstructive breast surgery.

 -  Psychiatric illness that would prevent the patient from giving informed consent.

 -  Patients for whom the delivery of PBI is not feasible

 -  Medical condition such as uncontrolled infection (including HIV), uncontrolled
 diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other
 collagen vascular diseases) that, in the opinion of the treating physician, would make
 this protocol unreasonably hazardous for the patient.

 -  Patients with a "currently active" second malignancy other than non-melanoma skin
 cancers. Patients are not considered to have "currently active" malignancies if they
 have completed therapy and are considered by their physicians to be at <5% risk of
 relapse within 3 years.

 -  Patients who are already enrolled in or planning to enroll in other adjuvant systemic
 therapy protocols for both non-invasive or invasive breast cancer.