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Radiation Therapy
Preoperative Radiation Therapy for Early-Stage Breast Cancer
N/A
Recruiting
Led By Parul Barry, MD
Research Sponsored by Parul Barry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All invasive subtypes and DCIS
Clinical size ≤ 2 cm based on results of dedicated breast imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether pre-operative radiation therapy improves outcomes for patients with early stage, biologically favorable breast cancer.
Who is the study for?
This trial is for women over 50 with early-stage, hormone-positive, HER2-negative breast cancer that's ≤2 cm in size and not spread to lymph nodes. Participants should be generally healthy (ECOG ≤ 2), not pregnant or breastfeeding, willing to use contraception during treatment, and have no severe illnesses or prior invasive cancers (except certain skin cancers) within the last 5 years.Check my eligibility
What is being tested?
The study tests preoperative radiation therapy in patients with favorable early-stage breast cancer. It aims to improve outcomes by allowing doctors to assess tumor response before surgery. The goal is also to increase access to radiation therapy which has been underused.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones from radiation therapy may include skin irritation at the treatment site, fatigue, mild swelling of the breast area, and changes in breast texture.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer includes all types and DCIS.
Select...
My breast tumor is 2 cm or smaller, according to imaging tests.
Select...
I am biologically female.
Select...
I am 50 years old or older.
Select...
My tumor is located more than 1cm away from the chest wall and skin.
Select...
My cancer is ER positive and HER2 negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Acute Toxicities
Breast Cancer Treatment Outcome Scale (BCTOS)
Cosmesis (cosmetic outcome)
+6 moreSide effects data
From 2022 Phase 2 trial • 10 Patients • NCT0336771570%
Lymphocyte Count Decreased
60%
Alanine Aminotransferase Increased
50%
Rash Maculopapular
50%
Anemia
40%
Aspartate Aminotransferase Increased
40%
Platelet Count Decreased
40%
Hyponatremia
30%
Diarrhea
30%
Serum Amylase Increased
30%
Confusion
30%
Fatigue
20%
Nausea
20%
Pyramidal Tract Syndrome
20%
Headache
20%
Lipase increased
20%
Paresthesia
20%
Generalized Muscle Weakness
20%
Insomnia
20%
Hypophosphatemia
20%
Chest Wall Pain
20%
Hyperglycemia
20%
Dizziness
20%
Seizure
20%
Creatinine Increased
10%
Restlessness
10%
Skin + Subcutaneous tissue disorder (foot ulcer)
10%
Localized Edema
10%
Conjunctivitis
10%
Encephalopathy
10%
Anxiety
10%
Blood lactate dehydrogenase increased
10%
Hypotension
10%
Fall
10%
Abdominal Pain
10%
Central Nervous System Necrosis
10%
Alkaline phosphatase increased
10%
Arthralgia
10%
Hypoglycemia
10%
Oculomotor nerve disorder
10%
Alopecia
10%
Bruising (Injection Site)
10%
Papulopustular Rash
10%
Hoarseness
10%
Hypermagnesemia
10%
Hyperkalemia
10%
Peripheral Sensory Neuropathy
10%
Productive Cough
10%
Rash Acneiform
10%
Agitation
10%
Pain
10%
Peripheral Motor Neuropathy
10%
Facial nerve disorder
10%
Sinus Bradycardia
10%
Hypomagnesemia
10%
Gastroesophageal reflux disease
10%
Flatulence
10%
Hypoalbuminemia
10%
Delirium
10%
Depression
10%
Dry eye
10%
Dry Mouth
10%
Lymphocyte count increased
10%
Nasal Congestion
10%
Somnolence
10%
Tremor
10%
Urinary tract infection
10%
Urinary urgency
10%
Watering Eyes
10%
Weight Loss
10%
White Blood Cell Decreased
10%
Dysarthria
10%
Dysgeusia
10%
Dysphagia
10%
Epistaxis
10%
Eye disorder, other; Diplopia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nivolumab + Ipilimumab + Short-course Radiation Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation Therapy (RT)Experimental Treatment1 Intervention
Preoperative Dose-escalated RT (5 Cohorts):
The first 3 patients to consent to the study will be registered to Cohort 1; the second 3 patients to consent will be registered to Cohort 2; the next 3 patients to consent will be registered to Cohort 3. The remaining patients will be assigned 2 patients to each Cohort, starting with Cohort 4. From that point on, a statistical analysis will be done to calculate the dose for the next Cohort (5).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy (RT)
2008
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
Parul BarryLead Sponsor
Parul Barry, MDPrincipal InvestigatorUPMC Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer includes all types and DCIS.I have had radiation therapy in the same breast area before.My cancer has spread to nearby lymph nodes.I have had breast cancer in both breasts or twice in the same breast.If you have AIDS, you cannot participate in this study because the treatments may weaken your immune system.Your breast imaging shows no signs of lymph node involvement.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.I am a male diagnosed with breast cancer.My cancer has spread to distant parts of my body.I have been active and mostly self-sufficient in the last 3 months.My breast cancer was confirmed by a biopsy within the last 3 months.I have been cancer-free from any non-breast cancer, except for skin or cervical cancers, for at least 5 years.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I have a connective tissue disorder like lupus, scleroderma, or dermatomyositis with symptoms.I haven't been hospitalized for lung problems in the last 30 days.I plan to receive chemotherapy alongside other treatments for my breast cancer.My breast tumor is 2 cm or smaller, according to imaging tests.I cannot lay face down for MRI or CT scans.My breast cancer does not meet all the specific requirements listed earlier.I am biologically female.I am 50 years old or older.The tumor cannot be clearly seen on the MRI and CT scans before radiation therapy.I had a major heart attack in the last 6 months.You do not have lymphovascular space invasion (LVSI).I am currently on IV antibiotics for a bacterial or fungal infection.I have unexamined breast lumps or calcium deposits that haven't been biopsied.I have Paget's disease of the nipple.If you can have babies, you need to have a negative pregnancy test within 14 days before joining the study.I have liver problems causing jaundice or blood clotting issues.I am not pregnant or breastfeeding and will use birth control during treatment.My tumor is located more than 1cm away from the chest wall and skin.I have had breast cancer before, but not lobular carcinoma in situ (LCIS).My cancer is ER positive and HER2 negative.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation Therapy (RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators recruiting participants for this trial at present?
"The clinical trial is not actively recruiting, as per information on the website. It was initially posted in November 1st 2022 and later revised in October 20th 2022; nonetheless, 2603 other trials are currently accepting patients."
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