Ductal Breast Cancer Clinical Trial
Official title:
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
| NCT number | NCT00694577 |
| Other study ID # | 03-179 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2003 |
| Est. completion date | June 2021 |
| Verified date | October 2022 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
| Status | Completed |
| Enrollment | 324 |
| Est. completion date | June 2021 |
| Est. primary completion date | June 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital | Beth Israel Deaconess Medical Center, Boston Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion. | Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility. | 10 years | |
| Primary | Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy | Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy | 10 years | |
| Secondary | Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint | Number of patients who presented with moderate to severe composite toxicity as an endpoint | 8 years | |
| Secondary | Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation | Rate of moderate to severe breast fibrosis determined by number of patients who developed moderate to severe breast fibrosis after partial breast irradiation according to radiation dose level | 8 years | |
| Secondary | Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation | Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes. | 8 years | |
| Secondary | To Evaluate Patient Satisfaction | A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance. | 8 years |