External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks

Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01581619 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-351


Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed"). The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients. The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.


Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:
Abram Recht, MD, Beth Israel Deaconess Medical Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography - Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen - 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: - No distant metastasis - Not pregnant or breastfeeding - No diffuse suspicious microcalcifications - No prior radiation therapy to the ipsilateral or contralateral breast or thorax - No histologic evidence of lymphovascular invasion (LVI) - No histologic evidence of EIC - No history of cosmetic or reconstructive breast surgery - No psychiatric illness that would prevent the patient from giving informed consent - No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient - No other currently active second malignancy other than non-melanoma skin cancers
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