Percentage of Participants With Grade 2 or 3 Fibrosis
Primary
· 60 months
| Group | Value | 95% CI |
|---|---|---|
| PBI Radiotherapy 6 Gy | 18.30 | |
| PBI Radiotherapy 8 Gy | 12.30 |
Last reviewed · How we verify
NCT02276885
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Active, enrolled
NA
Results posted
Last updated 30 December 2025
What this trial tests
NA trial testing PBI Radiotherapy 6 Gy in Breast Cancer in 284 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
28 October 2014
Primary endpoint
7 December 2023
7 December 2023
7 December 2026
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 284 |
| Start date | 28 October 2014 |
| Primary completion | 7 December 2023 |
| Estimated completion | 7 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PBI Radiotherapy 6 Gy
- PBI Radiotherapy 8 Gy
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 50 to 90, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: From the date that subjects signed the ICF until the 5 years follow up visit (EOS). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PBI Radiotherapy 6 Gy
Serious: 0/144 (0%)
Deaths: 4/144
PBI Radiotherapy 8 Gy
Serious: 1/140 (1%)
Deaths: 4/140
Serious adverse events (1 terms)
| Reaction | System | PBI Radiotherapy 6 Gy | PBI Radiotherapy 8 Gy |
|---|---|---|---|
| Hip Fracture | Injury, poisoning and procedural complications | — | — |
Other adverse events (224 terms — click to expand)
| Reaction | System | PBI Radiotherapy 6 Gy | PBI Radiotherapy 8 Gy |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Dermatitis radiation | Injury, poisoning and procedural complications | — | — |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | — | — |
| Hot Flashes | Vascular disorders | — | — |
| Superficial Soft TIssue Fibrosis | Musculoskeletal and connective tissue disorders | — | — |
| Pain | General disorders | — | — |
| Breast Atrophy | Reproductive system and breast disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Breast pain | Reproductive system and breast disorders | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — |
| localized edema | General disorders | — | — |
| Breast Asymmetry | Musculoskeletal and connective tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Seroma | Injury, poisoning and procedural complications | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Skin induration | Skin and subcutaneous tissue disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Neck Pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| lymphedema | Vascular disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Weight Gain | Investigations | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Osteoporosis | Musculoskeletal and connective tissue disorders | — | — |
| Breast skin thickening | Reproductive system and breast disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Paresthesia | Nervous system disorders | — | — |
| Papulopustular rash | Infections and infestations | — | — |
| Breast dimpling | Reproductive system and breast disorders | — | — |
| Erythema multiforme | Skin and subcutaneous tissue disorders | — | — |
| telangiectasia | Skin and subcutaneous tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Urinary Incontinence | Renal and urinary disorders | — | — |
| joint range of motion decreased | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Hip Fracture.
Data from ClinicalTrials.gov NCT02276885 adverse events section.
Sponsor's own description
The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02276885
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02276885 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 30 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02276885.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing