Status:
COMPLETED
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Ductal Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
Detailed Description
* In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation". * Participants wi...
Eligibility Criteria
Inclusion
- Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
- Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT
- 18 years of age or older
- ECOG Performance Status 0
- Required laboratory data as outlined in the protocol
Exclusion
- Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
- Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
- Tumor \> 2.0cm, nodal involvement, or metastatic involvement
- Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma
- Known mutation carrier, including BRCA1 and BRCA2
- History of cosmetic or reconstructive breast surgery
- Psychiatric illness which would prevent the patient from giving informed consent
- Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
- Participants with a "currently active" second malignancy other than non-melanoma skin cancers
- Patients with diffuse (\> 1 quadrant or \>5cm) suspicious microcalcifications
- Women who are pregnant
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00694577
Start Date
September 1 2003
End Date
June 1 2021
Last Update
November 14 2022
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214