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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Boston Medical Center |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00694577 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study |
Estimated Enrollment: | 300 |
Study Start Date: | September 2003 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Experimental
Study Participants 1-100
|
Radiation: Partial Breast Irradiation
32 Gy-8 Treatments, 4 Treatment Days
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Group 2: Experimental
Study Participants 101-200
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Radiation: Partial Breast Irradiation
36 Gy- 9 Treatments, 4 1/2 Treatment Days
|
Group 3: Experimental
Study Participants 201-300
|
Radiation: Partial Breast Irradiation
40 Gy-10 Treatments, 5 Treatment days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alphonse Taghian, MD, PhD | 617-726-6050 | |
Contact: Jeanette Gentile | 617-643-0056 |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02214 | |
Principal Investigator: Alphonse Taghian, MD, PhD | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Jay Harris, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Abram Recht, MD | |
Boston Medical Center | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Lisa kachnic, MD 617-638-7070 |
Principal Investigator: | Alphonse Taghian, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Alphonse Taghian, MD, PhD ) |
Study ID Numbers: | 03-179 |
Study First Received: | June 6, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00694577 |
Health Authority: | United States: Institutional Review Board |
non-invasive breast cancer early invasive breast cancer radiation PBI |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |