Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver radiation therapy to prevent breast cancer from returning after surgery. Instead of the usual longer treatment schedule, this trial tests a shorter plan where patients receive radiation therapy for just 5 days in a row. Researchers want to see if this shorter schedule is both safe and effective for people who have had a mastectomy and, in some cases, chest wall reconstruction.

To be eligible for this trial, participants must be at least 30 years old, have invasive breast cancer that has been surgically treated with a mastectomy, and have clear tumor margins (meaning no cancer cells are found at the edges of the removed tissue). Participants cannot have distant cancer spread, and certain medical conditions may exclude them. If eligible, participants can expect to receive radiation therapy over a week and will be monitored closely throughout the study to ensure their safety and the effectiveness of this treatment approach. This trial is currently recruiting participants, and it's an opportunity to contribute to research that could help improve cancer care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Female or male patients with invasive breast cancer who have had mastectomy and have a chest wall reconstruction in progress or completed.
• • Age ≥ 30 years
• • Final AJCC Stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status). Pathological stage for all patients not receiving neoadjuvant chemotherapy. Higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy. T3N0 patients, either clinically by imaging before neoadjuvant chemotherapy, or by pathological stage at the time of surgery, are eligible. Exceptions to these criteria (e.g. for T4 or N3 patients) are possible after discussion with PI.
• • Histologically negative tumor margin.
• • ECOG Performance Status of 0 or 1
• Exclusion Criteria:
• • Patients with distant metastasis.
• • Patients who are pregnant or breastfeeding.
• • Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
• • All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) will not be eligible to enroll.
• • Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
• • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at \<5% risk of relapse within 3 years.
• • Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. However endocrine therapies (tamoxifen or aromatase inhibitors), anti-HER2 therapy and bisphosphonates are permitted without restriction even during protocol treatment. Standard-of-care maintenance treatments such as pembrolizumab and capecitabine are permitted during protocol treatment. All of these treatments are delivered routinely as SOC during conventional radiotherapy.
• • Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).