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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Boston Medical Center
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00694577
First received: June 6, 2008
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Ductal Breast Cancer
 Radiation: Partial Breast Irradiation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the rate and severity of cutaneous toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • To evaluate the risk of breast fibrosis and fat necrosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To evaluate cosmetic outcome [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To evaluate patient satisfaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To evaluate local and distant control rates [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: September 2003
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Study Participants 1-100
 Radiation: Partial Breast Irradiation
32 Gy-8 Treatments, 4 Treatment Days
Other Name: PBI
Radiation: Partial Breast Irradiation
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Other Name: PBI
Radiation: Partial Breast Irradiation
40 Gy-10 Treatments, 5 Treatment days
Other Name: PBI
Experimental: Group 2
Study Participants 101-200
 Radiation: Partial Breast Irradiation
32 Gy-8 Treatments, 4 Treatment Days
Other Name: PBI
Radiation: Partial Breast Irradiation
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Other Name: PBI
Radiation: Partial Breast Irradiation
40 Gy-10 Treatments, 5 Treatment days
Other Name: PBI
Experimental: Group 3
Study Participants 201-330
 Radiation: Partial Breast Irradiation
32 Gy-8 Treatments, 4 Treatment Days
Other Name: PBI
Radiation: Partial Breast Irradiation
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Other Name: PBI
Radiation: Partial Breast Irradiation
40 Gy-10 Treatments, 5 Treatment days
Other Name: PBI

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694577

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

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alphonse Taghian, MD, PhD, Professor of Radiation Oncology, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00694577     History of Changes
Other Study ID Numbers: 03-179
Study First Received: June 6, 2008
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
non-invasive breast cancer
early invasive breast cancer
radiation
PBI

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 23, 2013