New genetic test may help women with early breast cancer avoid unnecessary treatment
NCT ID NCT04916808
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 1,500 women with ductal carcinoma in situ (DCIS), a very early form of breast cancer, who have had breast-conserving surgery. Researchers want to see if a genetic test called DCISionRT helps doctors decide whether to add radiation or hormone therapy after surgery. The goal is to learn if the test leads to better, more personalized treatment plans.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will be selected from the clinical practices of the participating investigators and institutions. Patients who have been recently diagnosed with DCIS and are being evaluated for the need for further therapy will be screened for eligibility per the following eligibility criteria.
- Ages
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26 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care 2. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable) 3. Patient must be consented within 120 days after surgery 4. Patient must be eligible for, or have already received breast conserving surgery 5. Patient must be eligible to receive radiation and/or systemic treatment 6. Patient must be female and greater than 25 years old 7. Patient must be able to provide informed consent Exclusion Criteria: 1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing 2. Patient has invasive breast cancer or evidence in the ipsilateral or contralateral breast of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple 3. Patient has already been surgically treated with a mastectomy for primary DCIS 4. Patient has prior in situ or invasive breast cancer
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GenesisCare
Alexandria, New South Wales, 2015, Australia
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Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One-Week radiation for breast cancer: MRI precision may cut side effects
- New test may help tailor treatment for early breast cancer
- One-Week radiation shows promise for breast cancer patients
- Could monitoring replace surgery for some breast lesions?
- Breast cancer overdiagnosis? landmark trial tests monitoring vs. surgery for Low-Risk DCIS
- Radiation-Free path for Low-Risk breast cancer patients?