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

Not Applicable

Completed

Conditions: Ductal Breast Cancer

Interventions: 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

Registration Number: NCT00694577

Lead Sponsor: Massachusetts General Hospital

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 324

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Irradiation using 40 Gy / 10 fractions	Partial Breast Irradiation using 40 Gy /10 fractions	Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Irradiation using 36 Gy / 9 fractions	Partial Breast Irradiation using 32 Gy / 8 fractions	Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Irradiation using 40 Gy / 10 fractions	Partial Breast Irradiation using 36 Gy / 9 fractions	Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Irradiation using 36 Gy / 9 fractions	Partial Breast Irradiation using 36 Gy / 9 fractions	Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Irradiation using 36 Gy / 9 fractions	Partial Breast Irradiation using 40 Gy /10 fractions	Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Irradiation using 40 Gy / 10 fractions	Partial Breast Irradiation using 32 Gy / 8 fractions	Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Irradiation using 32 Gy / 8 fractions	Partial Breast Irradiation using 40 Gy /10 fractions	Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Irradiation using 32 Gy / 8 fractions	Partial Breast Irradiation using 32 Gy / 8 fractions	Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Irradiation using 32 Gy / 8 fractions	Partial Breast Irradiation using 36 Gy / 9 fractions	Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week

Primary Outcome Measures

Name	Time	Method
Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.	10 years	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.
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy	10 years	Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy

Secondary Outcome Measures

Name	Time	Method
To Evaluate Patient Satisfaction	8 years	A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance.
Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint	8 years	Number of patients who presented with moderate to severe composite toxicity as an endpoint
Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation	8 years	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
Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation	8 years	Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes.

Trial Locations

Locations (4): Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Boston Medical Center
🇺🇸
Boston, Massachusetts, United States