Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer

Study Overview
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Brief Summary
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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
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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 will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments. Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy. We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial. Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.

Official Title
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Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study

Conditions
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Ductal Breast Cancer

Intervention / Treatment
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* Radiation: 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irradiation using 32 Gy / 8 fractions<br>Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week | Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions<br>* 32 Gy-8 Treatments, 4 Treatment Days<br>* Other names: PBI;Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions<br>* 36 Gy- 9 Treatments, 4 1/2 Treatment Days<br>* Other names: PBI;Radiation: Partial Breast Irradiation using 40 Gy /10 fractions<br>* 40 Gy-10 Treatments, 5 Treatment days<br>* Other names: PBI;|
| Experimental: Irradiation using 36 Gy / 9 fractions<br>Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week | Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions<br>* 32 Gy-8 Treatments, 4 Treatment Days<br>* Other names: PBI;Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions<br>* 36 Gy- 9 Treatments, 4 1/2 Treatment Days<br>* Other names: PBI;Radiation: Partial Breast Irradiation using 40 Gy /10 fractions<br>* 40 Gy-10 Treatments, 5 Treatment days<br>* Other names: PBI;|
| Experimental: Irradiation using 40 Gy / 10 fractions<br>Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week | Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions<br>* 32 Gy-8 Treatments, 4 Treatment Days<br>* Other names: PBI;Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions<br>* 36 Gy- 9 Treatments, 4 1/2 Treatment Days<br>* Other names: PBI;Radiation: Partial Breast Irradiation using 40 Gy /10 fractions<br>* 40 Gy-10 Treatments, 5 Treatment days<br>* Other names: PBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation, non-invasive breast cancer, early invasive breast cancer, PBI