External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks
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Official title
A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed"). The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients. The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.
Study identification
- NCT ID
- NCT01581619
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2012 (Type not available)
- Primary completion
- Aug 2016 (Actual)
- Completion
- Aug 2019 (Actual)
- Last update posted
- Nov 2, 2020
2012 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Beth Isreal Deaconness Medical Center | Boston | Massachusetts | 02215 | — |
| Brigham and Women's Hosptial | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01581619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2020 · Synced Nov 11, 2026
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