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Definitive Radiation Therapy for Inoperable Breast Cancer

Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding radiation to usual breast cancer medicines helps shrink the cancer and keep it from getting worse. It is for people with breast cancer that has grown in or near the breast who cannot or do not want to have surgery. Joining does not stop you from having surgery later.

The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A biopsy (a tissue sample) shows breast cancer that has grown into nearby breast tissue. It must be lobular, ductal, or no special type.
  • Scans or an exam show cancer in the listed stage ranges: T1–T4, N0–N2, and M0–M1. These describe the tumor and how far it has spread.
  • The cancer cannot be removed by surgery, a surgeon finds surgery is not a good option for you, or you choose not to have surgery.
  • You are expected to live more than 6 months.
  • If you can become pregnant, you must have a negative pregnancy test when treatment starts.

Who can't join

  • You are getting other cancer treatment that works throughout the body. Hormone therapy, HER2-targeted therapy, and immunotherapy are allowed.
  • You have had radiation to the same breast or nearby lymph nodes (small parts of the body's immune system).
  • Your body size or shape prevents you from having the study's treatment planning or treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type * T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria * Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery. * Life expectancy \> 6 months * Negative pregnancy test at the time of start of treatment in any female of reproductive age Exclusion Criteria: * Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted) * Prior radiation to ipsilateral breast or regional nodes * Inability to receive study treatment planning and treatment secondary to body habitus

Study sites (1)

NY