Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Carlos E. Vargas, M.D. - Doctors and ...

Overseen byCarlos E. Vargas, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Eligibility Criteria

This trial is for individuals with confirmed breast cancer, clinical stage T0-T2 N0 M0, who can consent and complete tests. They must be able to visit the institution for follow-up and are planning surgery with whole breast radiotherapy. It's not for pregnant women, those not using contraception, prior chest radiation patients, recurrent cancer cases or people with severe illnesses.

Inclusion Criteria

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Able to and provides Institutional Review Board (IRB) approved study specific written informed consent

My breast cancer has been confirmed through a biopsy.

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Exclusion Criteria

I cannot undergo radiotherapy due to health reasons.

My treatment plan includes radiation therapy for lymph nodes.

I have not received any initial treatment before the main therapy.

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Treatment Details

Interventions

Hypofractionated Radiation Therapy (Radiation Therapy)

Trial OverviewThe study is examining hypofractionated radiation therapy before surgery in breast cancer patients. This method involves higher doses of radiation over a shorter period than traditional treatments, potentially improving tumor control with fewer side effects.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (hypofractionated radiation therapy)Experimental Treatment1 Intervention

Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Hypofractionated Radiotherapy for: