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Losartan for Radiation-Induced Fibrosis in Breast Cancer
Phase 2
Recruiting
Led By Patricia H Hardenbergh, MD
Research Sponsored by Shaw Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with clinical or pathologic stage 0-IV invasive breast cancer to include ductal carcinoma in situ (Tis), primary tumor cannot be assessed (TX) and all other primary tumor stage categories (T1-T4)
Is a candidate for unilateral post-surgery radiation therapy per National Comprehensive Cancer Network (NCCN) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years following the completion of radiation therapy
Awards & highlights
Study Summary
This trial tested a drug to reduce skin hardening caused by radiation therapy in breast cancer patients.
Who is the study for?
This trial is for women over 18 with stage 0-IV breast cancer who've had surgery and are set for radiation therapy. They must have normal kidney and liver function, not be pregnant or breastfeeding, and can't have autoimmune diseases, a history of certain conditions, or be on conflicting medications.Check my eligibility
What is being tested?
The study tests if Losartan, a drug that blocks TGF-β1 involved in fibrosis, can reduce scarring in the lung and breast from radiation treatment in breast cancer patients compared to a placebo.See study design
What are the potential side effects?
Losartan may cause dizziness due to low blood pressure, increased potassium levels which could affect heart rhythm, mild swelling or weight gain from fluid retention, and possible kidney function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with breast cancer at any stage.
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I am eligible for radiation therapy on one side after surgery, as per NCCN guidelines.
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I am 18 years old or older.
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I am female.
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I have had surgery to remove or reconstruct my breast.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years following the completion of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years following the completion of radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average levels of cellular senescence, transforming growth factor beta-1 (TGF-β1) and senescence-associated secretory phenotype (SASP) serum biomarkers
Fibrosis of the breast or reconstructed breast in irradiated breast cancer patients
Radiographic lung fibrosis in the radiation field of irradiated breast cancer patients
Secondary outcome measures
Change in breast volume
Cosmesis
Patient reported outcomes
+1 moreOther outcome measures
Incidence of Reoperation
Side effects data
From 2016 Phase 4 trial • 48 Patients • NCT0152974920%
Hepatitis C
20%
Sexual transmitted diseases
10%
Post lumbar puncture headache
10%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
FTC/TDF+MK-0518+Losartan
EFV/FTC/TDF + Losartan
FTC/TDF + MK-0518
EFV/FTC/TDF
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Mastectomy with LosartanExperimental Treatment1 Intervention
Participants who underwent a mastectomy will take losartan in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Group II: Breast Conservation Surgery with LosartanExperimental Treatment1 Intervention
Participants who underwent breast conservation surgery will take losartan in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Group III: Mastectomy with PlaceboPlacebo Group1 Intervention
Participants who underwent a mastectomy will take placebo in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Group IV: Breast Conservation Surgery with PlaceboPlacebo Group1 Intervention
Participants who underwent breast conservation surgery will take placebo in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Find a Location
Who is running the clinical trial?
Shaw Cancer CenterLead Sponsor
Steadman Philippon Research InstituteOTHER
9 Previous Clinical Trials
575 Total Patients Enrolled
Patricia H Hardenbergh, MDPrincipal InvestigatorMedical Director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman eligible for this trial.I have specific genetic mutations related to cancer.My breast cancer has come back or I've had radiation therapy for it before.I do not have any uncontrolled illnesses like heart failure, unstable angina, kidney disease, uncontrolled diabetes, cystic fibrosis, or fibromyalgia.I do not have an active autoimmune disease, except for allowed conditions.My breast cancer treatment includes radiation therapy for both breasts.I am not taking Losartan or similar drugs, and I can take pills.You have a known risk of falling.I am currently receiving chemotherapy.Your kidney function, measured by eGFR, is normal or higher than 60.I have been diagnosed with breast cancer at any stage.Your AST levels should be within a certain range, which is measured by a blood test.Your creatinine levels are within a certain range.I am eligible for radiation therapy on one side after surgery, as per NCCN guidelines.I am 18 years old or older.I am female.You have a lung disease seen on a CT scan before the study starts.Your alanine aminotransferase (ALT) level in the blood is not more than 2.5 times the normal limit.I have had surgery to remove or reconstruct my breast.
Research Study Groups:
This trial has the following groups:- Group 1: Mastectomy with Placebo
- Group 2: Breast Conservation Surgery with Placebo
- Group 3: Mastectomy with Losartan
- Group 4: Breast Conservation Surgery with Losartan
Awards:
This trial has 0 awards, including: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.
How hazardous is Breast Conservation Surgery with Losartan for individuals?
"Since this is a Phase 2 trial, meaning there are some safety results but none for efficacy, the team at Power estimated Breast Conservation Surgery with Losartan to be safe enough for a score of two."
Answered by AI
Are new participants being accepted into this experiment?
"Evidently, the clinical trial listed on clinicaltrials.gov is not actively recruiting patients. The study was initiated January 1st 2023 and last updated November 23rd 2022; yet, there are 406 other trials that currently require participants."
Answered by AI
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