N/A
N=324
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
Ductal Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00694577 ↗Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion. — 98; 101; 124 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Partial Breast Irradiation using 32 Gy / 8 fractions (Radiation); Partial Breast Irradiation using 36 Gy / 9 fractions (Radiation); Partial Breast Irradiation using 40 Gy /10 fractions (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion. |
98; 101; 124 | — |
| PRIMARY Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy |
6; 4; 1 | — |
| SECONDARY Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint |
46; 67; 100 | — |
| SECONDARY Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation |
37; 52; 83 | — |
| SECONDARY Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation |
21; 36; 56 | — |
| SECONDARY To Evaluate Patient Satisfaction |
94; 94; 110 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00694577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.