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

Primary Purpose

Ductal Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partial Breast Irradiation using 32 Gy / 8 fractions
Partial Breast Irradiation using 36 Gy / 9 fractions
Partial Breast Irradiation using 40 Gy /10 fractions
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Breast Cancer focused on measuring non-invasive breast cancer, early invasive breast cancer, radiation, PBI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Boston Medical Center
  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Irradiation using 32 Gy / 8 fractions

Irradiation using 36 Gy / 9 fractions

Irradiation using 40 Gy / 10 fractions

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
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
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.
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.

Full Information

First Posted
June 6, 2008
Last Updated
October 19, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00694577
Brief Title
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
Official Title
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Breast Cancer
Keywords
non-invasive breast cancer, early invasive breast cancer, radiation, PBI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irradiation using 32 Gy / 8 fractions
Arm Type
Experimental
Arm Description
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Arm Title
Irradiation using 36 Gy / 9 fractions
Arm Type
Experimental
Arm Description
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Arm Title
Irradiation using 40 Gy / 10 fractions
Arm Type
Experimental
Arm Description
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Intervention Type
Radiation
Intervention Name(s)
Partial Breast Irradiation using 32 Gy / 8 fractions
Other Intervention Name(s)
PBI
Intervention Description
32 Gy-8 Treatments, 4 Treatment Days
Intervention Type
Radiation
Intervention Name(s)
Partial Breast Irradiation using 36 Gy / 9 fractions
Other Intervention Name(s)
PBI
Intervention Description
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Intervention Type
Radiation
Intervention Name(s)
Partial Breast Irradiation using 40 Gy /10 fractions
Other Intervention Name(s)
PBI
Intervention Description
40 Gy-10 Treatments, 5 Treatment days
Primary Outcome Measure Information:
Title
Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
Description
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.
Time Frame
10 years
Title
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy
Description
Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint
Description
Number of patients who presented with moderate to severe composite toxicity as an endpoint
Time Frame
8 years
Title
Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation
Description
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
Time Frame
8 years
Title
Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation
Description
Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes.
Time Frame
8 years
Title
To Evaluate Patient Satisfaction
Description
A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance.
Time Frame
8 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alphonse Taghian, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22652104
Citation
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.
Results Reference
derived
PubMed Identifier
19620489
Citation
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.
Results Reference
derived

Learn more about this trial

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

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