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NCT01766297 · ClinicalTrials.gov registry record · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
A Phase 2 study of Breast Cancer and Breast Neoplasm, sponsored by Proton Collaborative Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 9
- Study locations
NCT01766297: Recruiting Phase 2 study of Breast Cancer and Breast Neoplasm, sponsored by Proton Collaborative Group.
NCT01766297 is a Phase 2 study of Breast Cancer and Breast Neoplasm that is actively recruiting participants, run by Proton Collaborative Group. The registered enrollment target is 132 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01766297, a Phase 2 study of Breast Cancer and Breast Neoplasm, is actively recruiting participants, sponsored by Proton Collaborative Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
Primary Outcome
Freedom from failure (FFF): The events for FFF will be the first ipsilateral breast cancer recurrence. It is expected that less than 3% of patients will experience an ipsilateral breast cancer recurrence (FFF ≥ 97%). A recurrence rate of ≥ 10% (FFF ≤ 90%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 90% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher.
Conditions Studied
Interventions
- RADIATION Proton Radiotherapy
Study Locations (9)
Virginia
- Inova Schar Cancer Institute - Fairfax
- Hampton University Proton Therapy Institute - Hampton
Arizona
- Mayo Clinic - Scottsdale
California
- California Protons Cancer Therapy Center - San Diego
Illinois
- Northwestern Medicine Chicago Proton Center - Warrenville
Maryland
- Maryland Proton Treatment Center - Baltimore
Michigan
- McLaren Proton Therapy Center - Flint
New York
- New York Proton Center - New York
Oklahoma
- Oklahoma Proton Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2013-02 |
| Est. Completion | 2035-01 |
| Phase | Phase 2 |
What NCT01766297 shows while recruiting
NCT01766297 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Proton Radiotherapy is the first listed.
NCT01766297 lists 9 locations in 8 states (Virginia, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT01766297 about?
NCT01766297 is a clinical study titled "Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer". The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to co...
What is the current status of trial NCT01766297?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2013-02. Estimated completion is 2035-01.
What conditions does trial NCT01766297 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasm, Cancer of the Breast, Breast Tumor.
What interventions are being tested in trial NCT01766297?
The interventions under investigation include: Proton Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT01766297?
This trial is sponsored by Proton Collaborative Group, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01766297 being conducted?
This trial has 9 study locations across Arizona, California, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01766297's enrollment target sits among peer trials
132 485th of 1224 higher than 738 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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