Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients (NCT05637216) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
United States43 participantsStarted 2023-08-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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-angi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing losartan — a blood pressure medication — to reduce radiation-induced fibrosis after breast cancer treatment; is this something worth discussing for my situation given where I am in my treatment?
2Since this is a Phase 2 trial, what do we know so far about whether losartan is safe for this purpose, and what gaps in knowledge still exist that I should be aware of before considering it?
3The trial is no longer enrolling new patients — does that mean there are other ways I could access losartan for fibrosis prevention, or are there similar studies that are still open that my care team could look into for me?
4One of the things this trial is tracking is lung fibrosis visible on imaging in the radiation field — is that a risk in my specific case based on where my radiation was or will be directed, and how closely would that be monitored?
5The trial is also measuring blood biomarkers like TGF-β1 and cellular senescence markers — are those types of biomarkers something my care team could track regardless of this trial, and would the results change how my recovery is managed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fibrosis of the breast or reconstructed breast in irradiated breast cancer patients
Timeframe: Baseline, 3-, 6-, 12- and 18- month follow up visits
2
Radiographic lung fibrosis in the radiation field of irradiated breast cancer patients
Timeframe: Baseline, 3- and 12- month follow up visits
3
Average levels of cellular senescence, transforming growth factor beta-1 (TGF-β1) and senescence-associated secretory phenotype (SASP) serum biomarkers
Timeframe: Baseline, day of last radiation therapy fraction, 3- and 12- month follow up visits