Overview

This trial is active, not recruiting.

Condition ductal breast cancer
Treatments partial breast irradiation
Phase phase 1
Sponsor Massachusetts General Hospital
Collaborator Dana-Farber Cancer Institute
Start date September 2003
End date October 2010
Trial size 330 participants
Trial identifier NCT00694577, 03-179

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Study Participants 1-100
partial breast irradiation PBI
32 Gy-8 Treatments, 4 Treatment Days
partial breast irradiation PBI
36 Gy- 9 Treatments, 4 1/2 Treatment Days
partial breast irradiation PBI
40 Gy-10 Treatments, 5 Treatment days
(Experimental)
Study Participants 101-200
partial breast irradiation PBI
32 Gy-8 Treatments, 4 Treatment Days
partial breast irradiation PBI
36 Gy- 9 Treatments, 4 1/2 Treatment Days
partial breast irradiation PBI
40 Gy-10 Treatments, 5 Treatment days
(Experimental)
Study Participants 201-330
partial breast irradiation PBI
32 Gy-8 Treatments, 4 Treatment Days
partial breast irradiation PBI
36 Gy- 9 Treatments, 4 1/2 Treatment Days
partial breast irradiation PBI
40 Gy-10 Treatments, 5 Treatment days

Primary Outcomes

Measure
To evaluate the feasibility of PBI directed XRT in selected stages 0 and 1 female breast cancer patients within each dose level.
time frame: 10 years

Secondary Outcomes

Measure
To evaluate the rate and severity of cutaneous toxicity
time frame: 10 years
To evaluate the risk of breast fibrosis and fat necrosis
time frame: 10 years
To evaluate cosmetic outcome
time frame: 10 years
To evaluate patient satisfaction
time frame: 10 years
To evaluate local and distant control rates
time frame: 10 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
Principal investigator Alphonse Taghian, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.