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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00694577
• Collaborator: Dana-Farber Cancer Institute (Other), Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Boston Medical Center (Other)
• Enrollment: 330
• Locations: 4
• Arms: 3
• Duration (Months): 213
• Patients Per Site: 82.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ductal Breast Cancer	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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 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; 32 Gy-8 Treatments, 4 Treatment Days; Other Names: PBI ; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions; 36 Gy- 9 Treatments, 4 1/2 Treatment Days; Other Names: PBI ; Radiation: Partial Breast Irradiation using 40 Gy /10 fractions; 40 Gy-10 Treatments, 5 Treatment days; Other Names: PBI
Experimental: Group 2 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; 32 Gy-8 Treatments, 4 Treatment Days; Other Names: PBI ; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions; 36 Gy- 9 Treatments, 4 1/2 Treatment Days; Other Names: PBI ; Radiation: Partial Breast Irradiation using 40 Gy /10 fractions; 40 Gy-10 Treatments, 5 Treatment days; Other Names: PBI
Experimental: Group 3 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; 32 Gy-8 Treatments, 4 Treatment Days; Other Names: PBI ; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions; 36 Gy- 9 Treatments, 4 1/2 Treatment Days; Other Names: PBI ; Radiation: Partial Breast Irradiation using 40 Gy /10 fractions; 40 Gy-10 Treatments, 5 Treatment days; Other Names: PBI

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. To evaluate the rate and severity of cutaneous toxicity [10 years]

2. To evaluate the risk of breast fibrosis and fat necrosis [10 years]

3. To evaluate cosmetic outcome [10 years]

4. To evaluate patient satisfaction [10 years]

5. To evaluate local and distant control rates [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	Boston Medical Center	Boston	Massachusetts	United States	02118
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02214

Sponsors and Collaborators

• Massachusetts General Hospital
• Dana-Farber Cancer Institute
• Brigham and Women's Hospital
• Beth Israel Deaconess Medical Center
• Boston Medical Center

Investigators

• Principal Investigator: Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alphonse Taghian, MD, PhD, Professor of Radiation Oncology, Harvard Medical School, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00694577
• Other Study ID Numbers: 03-179
• First Posted: Jun 10, 2008
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alphonse Taghian, MD, PhD, Professor of Radiation Oncology, Harvard Medical School, Massachusetts General Hospital: non-invasive breast cancer; early invasive breast cancer; radiation; PBI
• Additional relevant MeSH terms: Breast Neoplasms; Carcinoma, Ductal, Breast

Study Results

No Results Posted as of Aug 24, 2021