Losartan for Radiation-Induced Heart Failure in Breast Cancer

Overseen by Rachel Jimenez, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Massachusetts General Hospital

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer. The interventions involved in this study are: * Losartan * Radiation Therapy (standard of care)

Research Team

Rachel Jimenez, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with non-metastatic left-sided breast cancer scheduled for radiation therapy, including internal mammary lymph nodes. They must be able to consent and have no MRI contraindications. Excluded are pregnant or breastfeeding individuals, those allergic to Losartan biosimilars, unable to swallow pills, or already on ACE/ARBs.

Inclusion Criteria

You are not restricted from having an MRI scan.

I have breast cancer that hasn't spread and will receive radiation therapy to the left side, including lymph nodes.

My breast cancer is in the left breast.

Exclusion Criteria

You have had allergic reactions to medications similar to Losartan.

I cannot swallow pills.

You can still join the study if you are taking a new, experimental drug, unless you are already in a study testing heart-related side effects.

Treatment Details

Interventions

• Losartan (Angiotensin II Receptor Blocker)
• Radiation Therapy (Radiation)

Trial Overview The study tests if Losartan can prevent heart failure caused by radiation in breast cancer treatment. Participants will receive standard radiation therapy and either Losartan or a placebo to compare outcomes.

Participant Groups

Group I: Radiation Therapy and Losartan Experimental Treatment 2 Interventions

Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School