Hypofractionated radiotherapy for non-metastatic breast cancer treatment
A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups
This study is testing if giving a shorter course of radiation therapy before or after surgery can help women with non-metastatic breast cancer while causing fewer severe side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06635980 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed non-metastatic breast cancer who are eligible for radiotherapy.
Not a fit: Patients with medical contraindications to radiotherapy or severe concurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with non-metastatic breast cancer.
How similar studies have performed: Previous studies have shown promising results with hypofractionated radiotherapy in breast cancer treatment, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.