CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 132 target
Drug / intervention
Proton Radiotherapyradiation
Likely dose
Not stated in record
Key inclusion· 15
  • ✓Female, age ≥50 years
  • ✓Life expectancy of at least 5 years based on age and co-morbidities
  • ✓Pathology proven invasive ductal carcinoma or ductal carcinoma in situ (DCIS); lobular not allowed
  • ✓Microscopically multifocal tumors must be 3.0 cm or less in total aggregate size within a single scar, or no multifocal tumor
Key exclusion· 15
  • ✕Previous history of ipsilateral invasive breast cancer or DCIS
  • ✕Clinical or radiographically suspicious nodes unless biopsy proven benign
  • ✕Non-epithelial malignancies such as sarcoma or lymphoma
  • ✕Suspicious residual microcalcifications on mammography unless negative for malignancy on pathology

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01766297
NCT01766297Phase 2RecruitingOn TrackUpdated 9mo ago
Long Recruiting
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Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Proton Collaborative Group·interventional·Posted Jan 11, 2013·Updated Sep 9, 2025

In Brief

A Phase 2 clinical trial evaluating Proton Radiotherapy for Breast Cancer and 3 related conditions. Currently recruiting, targeting 132 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
20132014201520162017201820192020202120222023202420252026202720282029203020312032203320342035
First PostedJan 11, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJan 1, 2027
Study CompletionJan 1, 2035
TodayJul 2, 2026
Enrollment to primary: 13.9 yearsPosted 13.5 years agoPrimary completion in 6 months

Interventions

Proton Radiotherapyradiation