IRB Study Number 24-729a
Status Recruiting
Institute Taussig Cancer Institute
Description
Aim1:
Percent of Cases with Changes in Treatment Recommendation [Time Frame: 2 years]
• The percent of cases in which treatment recommendations are changed after the test DCISionRT test results become available.
The study will collect details on physician treatment recommendations and patient preference before and after the availability of the molecular test (DCISionRT) results.
The data elements include type of surgery (lumpectomy, therapeutic mastectomy, contralateral prophylactic mastectomy), type of radiation therapy (none, IORT, APBI/PBI, whole breast RT, boost) and endocrine therapy (yes, no).
Long term ipsilateral breast cancer recurrence and radiation therapy benefit [Time Frame: 5-14 years]
• The 5- and 10-year ipsilateral breast cancer recurrence rates with and without RT by DCISionRT test categories and by continuous test result
Aim 2:
Function of Demographic Factors [Time Frame: 2 years]
• Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of demographic factors (age; ethnicity; family history, education, marital status, geographic region)
Function of Tumor Factors [Time Frame: 2 years]
• Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of tumor factors (tumor size, nuclear grade, architecture, necrosis, palpability, surgical margins, hormone receptor status).
Aim 3:
Distribution of DCISionRT scores across the cohort [Time Frame: 2 years]
• Each patient will receive the following results from the DCISionRT test: Decision Score (DS, 0.8-10.0), Residual Risk subtype (DS 9.2), including Race and Ethnicity.
Function of Geographic Region [Time Frame: 3 years]
• Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of the geographic region of the investigator, type of institution, or type of treating physician.
Inclusion Criteria
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).
Patient must have the DCISionRT test ordered during routine patient care.
Patient must be eligible for or have recently completed breast conserving surgery.
Patient must be eligible to receive radiation and/or systemic treatment.
Patient must be 30 to 85 years old.
Patient must have tumor size of less than 6 cm.
Patient must have been diagnosed with DCIS within 120 days of consent.
Exclusion Criteria
Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
Patient has a prior history of in-field radiation in the ipsilateral breast.
Patient has had prior systemic endocrine or chemotherapy prior to testing.
Patient is pregnant.
