Hypofractionated radiotherapy for non-metastatic breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of hypofractionated radiotherapy administered either before or after breast surgery in patients with non-metastatic breast cancer. The study aims to compare the rates of severe radiation-related side effects between the two treatment approaches while also evaluating locoregional control and patient-reported outcomes. Participants will undergo various assessments, including tumor mutation analysis and monitoring for complications, to gather comprehensive data on treatment efficacy and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 18 years
* Histological confirmation of breast cancer
* Clinical stage T1-T4 N0-3 M0
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
* Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent
* Able to complete all mandatory tests listed in the trial
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Indications for radiotherapy for breast cancer

Exclusion Criteria:

* Medical contraindication to receipt of radiotherapy
* Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent in the judgment of the principal investigator
* Active systemic lupus or scleroderma
* Pregnancy
* Women of childbearing potential who are unwilling to employ adequate contraception
* Prior receipt of ipsilateral breast or chest wall radiation
* Recurrent breast cancer

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting

Study contacts

• Principal investigator: Carlos E. Vargas, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.