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Radiation After No Axillary Nodal Sampling

RADIation After no Axillary Nodal Sampling (RADIANS)

Who can join

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

Age
40 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

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years."
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 small study tests the safety of radiation to only part of the breast after surgery that keeps the breast. It is for women age 40 or older with invasive ductal breast cancer who did not have lymph nodes removed from the armpit during surgery.

This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.

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

Eligibility

Who can join

  • Assigned female at birth and age 40 or older.
  • Had surgery that kept the breast, without removing lymph nodes from the armpit.
  • Have invasive ductal cancer, which starts in the breast’s milk ducts and spreads into nearby tissue, confirmed by a tissue test.
  • The tumor measures less than 3 centimeters after surgery.
  • No signs of cancer in nearby lymph nodes on an exam or imaging scans.
  • Breast size allows radiation to only part of the breast.
  • Have a performance status score of 0–2, a rating of how well you can do daily activities.
  • Can give informed consent and are willing and able to follow the study’s visits, treatments, tests, and other steps.

Who can't join

  • Male.
  • Transgender or non-binary.
  • Had a mastectomy, or surgery to remove the breast.
  • Have cancer that has spread to distant parts of the body.
  • Have had cancer in either breast before.
  • Have barriers to giving informed consent or attending regular follow-up visits.

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

Official eligibility criteria

Inclusion Criteria: * Individuals assigned Female at birth, age 40 and older * Breast conserving surgery without SLNB or ALND * All patients should be capable of giving informed consent, * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Histologically confirmed invasive ductal carcinoma * Individuals with pathologic tumor size \<3cm * Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial. * Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging) * Electrocorticography (ECOG) performance status 0-2 Exclusion Criteria: * Male * Transgender or non-binary individuals. * Mastectomy * Metastatic disease * History of ipsilateral or contralateral breast cancer. * Obstacles to obtaining informed consent or undergoing regular follow-up

Study sites (1)

NY