Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
NCT ID: NCT05637216
Last Updated: 2024-09-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-08-17
Study Completion Date
2027-08-17
Brief Summary
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This study will evaluate the efficacy of losartan (LOS), an FDA-approved transforming growth factor beta-1 (TGF-β1) blocker, to decrease radiation induced fibrosis (RIF) in the breast and the lung of breast cancer patients, testing the hypothesis that Losartan will decrease RIF, TGF- β1 and cellular senescence/inflammation in the breast and the lung of irradiated breast cancer patients relative to placebo treatment and consequently improve clinical outcomes in breast cancer patients.
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Detailed Description
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This single site study will be conducted at the Vail Health Shaw Cancer Center in Edwards, Colorado. A block, double-blinded, placebo-controlled, randomized phase II design will be utilized .
Study participants will be blocked by surgical intervention (breast conserving surgery vs. mastectomy) and then randomized, 1:1, into the treatment and control arms for a total of four study arms. The research team and study participants will be blinded to the study arm and a placebo will be used to reduce detection bias in the reporting of outcomes. Selection bias will be minimized through the randomization of study arms.
Study participants will be prescribed 25mg capsules of placebo or the investigational drug, Losartan, to be taken by mouth once daily. The treatment start date will be the day that subject begins radiation therapy. Radiation therapy will continue to be prescribed in accordance with local clinic procedures. Treatment with the study intervention will continue for one year upon completion of radiation therapy. All participants will be assessed for fibrosis, cosmetic outcomes, and incidence of reoperation for 18 months following the completion of radiation therapy.
Study participants will be blocked by surgical intervention (breast conserving surgery vs. mastectomy) and then randomized, 1:1, into the treatment and control arms for a total of four study arms. The research team and study participants will be blinded to the study arm and a placebo will be used to reduce detection bias in the reporting of outcomes. Selection bias will be minimized through the randomization of study arms.
Study participants will be prescribed 25mg capsules of placebo or the investigational drug, Losartan, to be taken by mouth once daily. The treatment start date will be the day that subject begins radiation therapy. Radiation therapy will continue to be prescribed in accordance with local clinic procedures. Treatment with the study intervention will continue for one year upon completion of radiation therapy. All participants will be assessed for fibrosis, cosmetic outcomes, and incidence of reoperation for 18 months following the completion of radiation therapy.
Conditions
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Radiation Induced Fibrosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be blocked by surgical type (breast conservation surgery/mastectomy) and then randomized 1:1 in a parallel design into treatment and control arms. All participants will take an oral 25 milligram tablet once daily of either losartan or placebo.
Assessments of fibrosis will include provider assessments and participant reported outcomes of fibrosis and cosmesis, the participant's decision for reoperation, laboratory assessments of inflammatory biomarkers, a CT scan and bilateral mammograms.
Assessments of fibrosis will include provider assessments and participant reported outcomes of fibrosis and cosmesis, the participant's decision for reoperation, laboratory assessments of inflammatory biomarkers, a CT scan and bilateral mammograms.
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Participants, research staff and clinicians will be blinded from study group assignment.
Study Groups
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Breast Conservation Surgery with Losartan
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 Type
EXPERIMENTAL
Losartan 25 milligram capsule
Intervention Type
DRUG
Losartan 25 milligram oral capsule
Breast Conservation Surgery with Placebo
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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo 25 milligram oral capsule
Mastectomy with Losartan
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 Type
EXPERIMENTAL
Losartan 25 milligram capsule
Intervention Type
DRUG
Losartan 25 milligram oral capsule
Mastectomy with Placebo
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 Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo 25 milligram oral capsule
Interventions
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Losartan 25 milligram capsule
Losartan 25 milligram oral capsule
Intervention Type
DRUG
Placebo
Placebo 25 milligram oral capsule
Intervention Type
DRUG
Other Intervention Names
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losartan potassium
Eligibility Criteria
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Inclusion Criteria
* 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)
* Has been treated with breast conserving surgery or mastectomy with reconstruction
* Is a candidate for unilateral post-surgery radiation therapy per National Comprehensive Cancer Network (NCCN) guidelines
* Age ≥ 18
* Female
* Laboratory values
* Aspartate Aminotransferase (AST) ≤ 2.5 x Upper Limit Normal (ULN)
* Alanine Aminotransferase (ALT) ≤ 2.5 x ULN
* Creatine ≤ 1.5 x ULN
* Estimated Glomerular Filtration Rate (eGFR) ≥ 60
Inclusion of Women and Minorities - Women of any race/ethnicity are eligible for this trial.
* Has been treated with breast conserving surgery or mastectomy with reconstruction
* Is a candidate for unilateral post-surgery radiation therapy per National Comprehensive Cancer Network (NCCN) guidelines
* Age ≥ 18
* Female
* Laboratory values
* Aspartate Aminotransferase (AST) ≤ 2.5 x Upper Limit Normal (ULN)
* Alanine Aminotransferase (ALT) ≤ 2.5 x ULN
* Creatine ≤ 1.5 x ULN
* Estimated Glomerular Filtration Rate (eGFR) ≥ 60
Inclusion of Women and Minorities - Women of any race/ethnicity are eligible for this trial.
Exclusion Criteria
* Recurrent breast cancer and history of prior breast radiation therapy
* Breast cancer requiring bilateral breast/chest wall radiation therapy
* Undergoing concurrent chemotherapy treatment
* Documented fall risk
* Active known diagnosis of a connective tissue disorder, rheumatoid arthritis, or systemic lupus erythematosus (SLE)
* Any known uncontrolled intercurrent illness including, but not limited to:
* Hyperkalemia
* Impaired renal function
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Kidney disease
* Uncontrolled diabetes
* Cystic fibrosis
* Fibromyalgia based on American College of Rheumatology criteria
* Concomitant use of:
* Losartan
* Other renin-angiotensin system (RAS) agent
* Agents to increase serum potassium
* Lithium
* Aliskiren for diabetes
* Having a known allergy to any active or inactive ingredient in Losartan
* Unable to tolerate oral medication
* Pregnant or breast-feeding or planning pregnancy for the year following radiation
* A medical history of interstitial lung disease or evidence of interstitial lung disease
* Patients with any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Clinical Investigator or his/her designee), constitutes a risk or contraindication for participation in the study or that could interfere with the study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the study
* Individuals known to possess deoxyribonucleic acid (DNA) gene mutations including:
* Ataxia-Telangiectasia Mutated (ATM)
* Double-strand-break repair protein rad21 homolog (RAD21)
* C-to-T single-nucleotide polymorphism (C-509T) in the Transforming growth factor β-1 gene
* Breast cancer requiring bilateral breast/chest wall radiation therapy
* Undergoing concurrent chemotherapy treatment
* Documented fall risk
* Active known diagnosis of a connective tissue disorder, rheumatoid arthritis, or systemic lupus erythematosus (SLE)
* Any known uncontrolled intercurrent illness including, but not limited to:
* Hyperkalemia
* Impaired renal function
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Kidney disease
* Uncontrolled diabetes
* Cystic fibrosis
* Fibromyalgia based on American College of Rheumatology criteria
* Concomitant use of:
* Losartan
* Other renin-angiotensin system (RAS) agent
* Agents to increase serum potassium
* Lithium
* Aliskiren for diabetes
* Having a known allergy to any active or inactive ingredient in Losartan
* Unable to tolerate oral medication
* Pregnant or breast-feeding or planning pregnancy for the year following radiation
* A medical history of interstitial lung disease or evidence of interstitial lung disease
* Patients with any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Clinical Investigator or his/her designee), constitutes a risk or contraindication for participation in the study or that could interfere with the study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the study
* Individuals known to possess deoxyribonucleic acid (DNA) gene mutations including:
* Ataxia-Telangiectasia Mutated (ATM)
* Double-strand-break repair protein rad21 homolog (RAD21)
* C-to-T single-nucleotide polymorphism (C-509T) in the Transforming growth factor β-1 gene
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Steadman Philippon Research Institute
OTHER
Sponsor Role
collaborator
Shaw Cancer Center
OTHER
Sponsor Role
lead
Responsible Party
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Patricia Hardenbergh
Medical Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Patricia H Hardenbergh, MD
Role: PRINCIPAL_INVESTIGATOR
Vail Health Shaw Cancer Center
Locations
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Vail Health Shaw Cancer Center
Edwards, Colorado, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Patricia H Hardenbergh, MD
Role: backup
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