Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
The purpose of this study is to determine if the dose of radiation therapy that is effective
 in producing a treatment response, delivered over a shorter treatment period, is a safe
 approach that causes few or mild side effects in women with newly diagnosed breast cancer or
 DCIS who have had a lumpectomy procedure.
Inclusion Criteria:

 -  Female

 -  Age >/= 45 years

 -  Unicentric pathological stage I (pT1 or T2 pN0_M0) invasive ductal breast cancer or
 DCIS measuring <3 cm in longest diameter on pathology and/or mammogram that is
 histologically confirmed. If T2, the tumor must be less than 3cm in longest diameter.
 Note: 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 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

 -  Histologically negative tumor margin or no tumor in a re-excision specimen on final
 shaved specimen.

 -  ECOG Performance Status of 0 or 1.

 -  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.

 -  Negative serum pregnancy test within 14 days prior to study treatment if a woman has
 child-bearing potential. Subjects of child bearing potential are those who have not
 been surgically sterilized or have not been free from menses for > 1 year

 -  Written informed consent obtained from subject and ability for subject or comply with
 the requirements of the study

 -  Female subjects of childbearing potential should be willing to use 2 methods or birth
 control or be surgically sterile or abstain from heterosexual activity for the
 duration of study participation. Should a woman become pregnant while participating on
 study, she should inform the treating physician immediately.

 Inclusion Criteria for intermediate risk substudy:

 -  Post-NAC cohort patients: clinical T1 or T2 (less than or equal to 5cm in longest
 diameter on available imaging) and clinical N0 (on exam and imaging) with pathological
 pT0 or pTis and pN0 (any regimen of neoadjuvant chemotherapy agents is allowed)

 OR

 -  Oncotype RS score of 26 or higher

 OR

 -  PAM50 ROR scored as "HIGH"

 OR

 -  Presence or LVI (focal, limited or "not otherwise specified") in the lumpectomy
 specimen

 OR

 -  Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign
 breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant
 or prior LCIS in either breast, 4) no family history of breast cancer in first degree
 relatives)

 OR

 -  Invasive lobular carcinoma

 OR

 -  Women 70 or older with tumors 2.0 cm or less in size and with clinically or
 pathologically negative nodes who decline or are ineligible for hormonal therapy OR
 discontinue hormonal therapy within 3 months of initiating treatment.

 Exclusion Criteria:

 -  Patients with distant metastasis

 -  Patients who are pregnant or breastfeeding

 -  Patients with diffuse (>1 quadrant or >5cm) suspicious microcalcifications or patients
 with known multicentric OR multifocal disease. (microscopic multifocal disease that
 may be unifocal and/or appear multifocal due to sectioning is allowed after review
 with PI).

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

 -  Histological evidence of extensive lymphovascular invasion (LVI)

 -  Histological evidence of extensive intraductal component (EIC), defined as the
 presence of intraductal carcinoma both within the primary infiltrating ductal tumor
 (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly
 beyond the edges of the invasive tumor.

 -  Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests
 in order to enroll on the study. Note: 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 be given the option of remaining on the breast conservation paradigm or opting
 for mastectomy (as is done in this rare scenario is standard of care practice). The
 patient will be replaced on the trial.

 -  History of cosmetic or reconstructive breast surgery.

 -  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

 -  Expecting to conceive within the projected duration of the trials, starting with
 screening visit through 180 days after the last dose of trial treatment

 -  Concomitant anti-neoplastic treatment is not allowed during protocol treatment and
 should be completed at least 2 weeks prior to commencement of protocol treatment, with
 resolution of associated acute toxicities. Bisphosponates are permitted without
 restriction even during protocol treatment. Note: This does not apply to hormonal
 therapies such as tamoxifen or AIs, which are permitted. This does not apply to
 anti-Her2 therapies such as trastuzumab or TDM-1, which are also permitted.

 -  Ongoing therapy with other investigational agents. Patients may not be receiving any
 other investigational agents.