Radiation Therapy (RT) for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Magee Womens Hospital - Radiation Oncology, Pittsburgh, PA
Breast Cancer+1 More
Radiation Therapy (RT) - Radiation
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether pre-operative radiation therapy improves outcomes for patients with early stage, biologically favorable breast cancer. Radiation Therapy (RT) is being used to treat Breast Cancer in this trial, as it has been approved by the FDA for a different condition. No patients will be given a placebo in this trial.

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 5 years

Year 3
Breast Cancer Treatment Outcome Scale (BCTOS)
Quality of Life - EORTC QLQ BR23
Year 3
Cosmesis (cosmetic outcome)
Month 24
Late toxicities
Up to 1 month
Acute Toxicities
Up to 3 years
Pathologic Response (PR)
Up to 5 years
Disease free Survival (DFS)
Loco-regional recurrence
Overall survival (OS)
Up to18 months (cohort)
Maximum tolerated dose (MTD)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Nivolumab + Ipilimumab + Short-course Radiation Therapy
70%Lymphocyte Count Decreased
60%Alanine Aminotransferase Increased
50%Anemia
50%Rash Maculopapular
40%Hyponatremia
40%Platelet Count Decreased
40%Aspartate Aminotransferase Increased
30%Fatigue
30%Confusion
30%Diarrhea
30%Serum Amylase Increased
20%Insomnia
20%Nausea
20%Dizziness
20%Creatinine Increased
20%Paresthesia
20%Seizure
20%Chest Wall Pain
20%Generalized Muscle Weakness
20%Hyperglycemia
20%Lipase increased
20%Headache
20%Hypophosphatemia
20%Pyramidal Tract Syndrome
10%Agitation
10%Hypoglycemia
10%Eye disorder, other; Diplopia
10%Papulopustular Rash
10%Nasal Congestion
10%Hyperkalemia
10%Oculomotor nerve disorder
10%Hoarseness
10%Somnolence
10%Dry Mouth
10%Hypotension
10%Alopecia
10%Arthralgia
10%Conjunctivitis
10%Fall
10%Epistaxis
10%Flatulence
10%Abdominal Pain
10%Depression
10%Dry eye
10%Dysarthria
10%Bruising (Injection Site)
10%Dysgeusia
10%Gastroesophageal reflux disease
10%Delirium
10%Hypoalbuminemia
10%Pain
10%Restlessness
10%Sinus Bradycardia
10%Encephalopathy
10%Dysphagia
10%Alkaline phosphatase increased
10%Localized Edema
10%Tremor
10%Central Nervous System Necrosis
10%Facial nerve disorder
10%Anxiety
10%Lymphocyte count increased
10%Blood lactate dehydrogenase increased
10%Hypomagnesemia
10%Skin + Subcutaneous tissue disorder (foot ulcer)
10%White Blood Cell Decreased
10%Hypermagnesemia
10%Watering Eyes
10%Peripheral Sensory Neuropathy
10%Productive Cough
10%Peripheral Motor Neuropathy
10%Urinary urgency
10%Urinary tract infection
10%Rash Acneiform
10%Weight Loss
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03367715) in the Nivolumab + Ipilimumab + Short-course Radiation Therapy ARM group. Side effects include: Lymphocyte Count Decreased with 70%, Alanine Aminotransferase Increased with 60%, Anemia with 50%, Rash Maculopapular with 50%, Hyponatremia with 40%.

Trial Design

1 Treatment Group

Radiation Therapy (RT)
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Radiation Therapy (RT) · No Placebo Group · N/A

Radiation Therapy (RT)
Radiation
Experimental Group · 1 Intervention: Radiation Therapy (RT) · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy (RT)
2008
Completed Phase 2
~150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: UPMC Magee Womens Hospital - Radiation Oncology · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Breast Cancer
0 CompletedClinical Trials

Who is running the clinical trial?

Parul BarryLead Sponsor
Parul Barry, MDPrincipal InvestigatorUPMC Hillman Cancer Center

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Breast cancer diagnosis within 90 days from breast biopsy.
The breast is less than 2 cm in size.
You have 3 or more clinically negative lymph nodes based on results of dedicated breast imaging.
The gross tumor should be >1cm from the chest wall and the skin surface.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.