The investigators proposed approach allows them to deliver a low total dose of radiation to
patients with low-risk, early-stage breast cancer which would further minimize the impact of
adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by
allowing it to take place at many radiation oncology centers with minimal specialized
equipment beyond that commonly available. The investigators first step is this proposed
single institution phase I/II study designed primarily to evaluate the tolerance of this
approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).
Inclusion Criteria:
- AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed
carcinoma of the breast, treated with partial mastectomy. Axillary sampling is
required only for cases of invasive cancers. Tumor size is determined by the
pathologist. Clinical size may be used if the pathologic size is indeterminate.
Patients with invasive cancer must have no positive axillary lymph nodes with at least
6 axillary lymph nodes sampled or a negative sentinel node.
- Negative histologic margins of partial mastectomy or re-excision specimen. Margins
generally are positive if there is invasive or noninvasive tumor at the inked
resection margin, close but negative if the tumor is within 2 mm of the inked margin
and negative if the tumor is at least 2 mm away from the inked edge.
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular
histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone
receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma
in situ (lesions ≤ 2 cm).
- Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to
TRI-APBI, but adjuvant hormone therapy may have been started after surgery. Planned
chemotherapy or biologic therapy must not start for at least 4 weeks after the
completion of TRI-APBI.
- Good candidate for treatment per protocol in the judgment of the PI and/or treating
physician following simulation.
- Postmenopausal status.
- Age ≥ 50 years at diagnosis.
- Able to understand and willing to sign IRB-approved written informed consent document.
- English speaker.
- All radiation therapy must be planned for delivery at BJH. External beam patients will
be treated at BJH on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit.
Brachytherapy cases will be treated in the BJH brachytherapy center. Pre and post
treatment care is allowed at any Siteman center.
Exclusion Criteria:
- Presence of distant metastases.
- Nonepithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors
separated by at least 4 cm) with other clinically or radiographically suspicious areas
in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable
or radiographically suspicious contralateral axillary, supraclavicular,
infraclavicular, or internal mammary nodes, unless there is histologic confirmation
that these nodes are negative for tumor.
- Prior non-hormonal therapy for the present breast cancer, including radiation therapy
or chemotherapy.
- Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
- History of other malignancy ≤ 5 years previous with the exception of basal cell or
squamous cell carcinoma of the skin which were treated with local resection only or
carcinoma in situ of the cervix.
- Paget's disease of the nipple.
- Skin involvement, regardless of tumor size.
- Unsatisfactory breast for TRI-APBI as determined by the treating physician. For
example, if there is little breast tissue remaining between the skin and pectoralis
muscle after surgery, treatment with TRI-APBI is technically problematic.
- Partial mastectomy so extensive that the cosmetic result is fair or poor prior to
TRI-APBI as determined by the treating physician.
- Surgical margins which cannot be microscopically assessed or are positive at
pathological evaluation.
- Time between final definitive breast procedures to TRI-APBI simulation is greater than
8 weeks.
