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

Mass General Brigham

Status: Completed

Conditions: Ductal Breast Cancer

Treatments: Radiation: Partial Breast Irradiation using 40 Gy /10 fractions; Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions

Study type: Interventional

Funder types: Other

Identifiers

NCT00694577

03-179

Details and patient eligibility

About

The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.

Full 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.

Enrollment: 324 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

324 participants in 3 patient groups

Irradiation using 32 Gy / 8 fractions

Experimental group

Description:

Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week

Treatment:

Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions

Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions

Radiation: Partial Breast Irradiation using 40 Gy /10 fractions

Irradiation using 36 Gy / 9 fractions

Experimental group

Description:

Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week

Treatment:

Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions

Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions

Radiation: Partial Breast Irradiation using 40 Gy /10 fractions

Irradiation using 40 Gy / 10 fractions

Experimental group

Description:

Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week

Treatment:

Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions

Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions

Radiation: Partial Breast Irradiation using 40 Gy /10 fractions