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

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

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

Study Overview

• Status: Completed
• Conditions: Ductal Breast Cancer
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Irradiation using 32 Gy / 8 fractions; 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: Irradiation using 36 Gy / 9 fractions; 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: Irradiation using 40 Gy / 10 fractions; 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

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Pashtan IM, Recht A, Ancukiewicz M, Brachtel E, Abi-Raad RF, D'Alessandro HA, Levy A, Wo JY, Hirsch AE, Kachnic LA, Goldberg S, Specht M, Gadd M, Smith BL, Powell SN, Taghian AG. External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e271-7. doi: 10.1016/j.ijrobp.2012.04.019. Epub 2012 May 30.
• Recht A, Ancukiewicz M, Alm El-Din MA, Lu XQ, Martin C, Berman SM, Hirsch AE, Kachnic LA, Katz A, MacDonald S, Nedea EA, Stevenson MA, Powell SN, Taghian AG. Lung dose-volume parameters and the risk of pneumonitis for patients treated with accelerated partial-breast irradiation using three-dimensional conformal radiotherapy. J Clin Oncol. 2009 Aug 20;27(24):3887-93. doi: 10.1200/JCO.2008.20.0121. Epub 2009 Jul 20.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (ESTIMATE): June 10, 2008

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: radiation; PBI; non-invasive breast cancer; early invasive breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Breast Neoplasms; Carcinoma, Ductal, Breast
• Other Study ID Numbers: 03-179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO