RecruitingPhase 2

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study

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

  • Time periods mentioned: 10 years
  • Procedures mentioned: MRI scans, Blood draws

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
  • "Participants will be asked to return for evaluation with MRI at three months and six months."
  • "In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care."
  • "Depending on the evaluation, participants will have the option to continue on the treatment, with follow up evaluations of Mammogram and MRI at 6 month intervals."
  • "In addition to the treatment and MRI evaluation, participants will be asked to: * Provide blood sample to understand their immune status * Provide saliva sample for genetic testing * Provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care."
  • "Participants will be followed annually for 10 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 study tests whether close monitoring and hormone treatment can manage DCIS, an early form of breast cancer. It is for women age 18 or older whose DCIS responds to hormones. Participants have MRI scans at 3 and 6 months and may continue treatment or stop it and have surgery, based on the results.

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

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

Eligibility

Who can join

  • Be female and at least 18 years old.
  • Have DCIS with at least 50% of cells testing positive for estrogen or progesterone receptors, which let hormones affect the cells. Tiny areas of cancer spread are allowed.
  • You may join if earlier DCIS surgery left cancer cells at the edges of the removed tissue and you have not had another surgery to remove them.
  • If you previously took hormone treatment, stop it for at least 4–6 weeks before the screening MRI.
  • Have recent breast imaging: a mammogram of both breasts within 6 months, or one within 12 months plus a single-breast mammogram within 6 months. Have an MRI on a study-approved scanner within 60 days before treatment.
  • Have blood count, blood chemistry, and cholesterol tests within the past year. Abnormal tests must be repeated within 60 days before treatment and judged not medically important by the study doctor.
  • Have a negative pregnancy test within 1 month before treatment and be willing and able to provide tumor samples for research.
  • People with controlled HIV may join if their medicines do not conflict with the study drug.

Who can't join

  • Be pregnant or breastfeeding.
  • Have an allergy to drugs similar to the study drug, or a history of a severe allergy or reaction to MRI contrast dye.
  • Have invasive breast cancer, meaning cancer that has spread into nearby breast tissue, or have received treatment for another cancer within the past 6 months.
  • Be in another drug trial that requires an Investigational New Drug application, or be receiving DCIS treatment outside this study's plan.
  • Have an uncontrolled illness, including a mental health condition, that would make it hard to follow study requirements.
  • Have conditions that may affect how your body absorbs the pills, including active bowel inflammation, long-term diarrhea, active hepatitis A, B, or C, liver scarring, short bowel syndrome, or past upper digestive tract surgery.
  • Be unable to swallow normally or take tablets and capsules, or be unlikely to take the pills as directed.
  • Have interference in MRI images, such as from a pacemaker or other hardware, that prevents doctors from checking the breast area.

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

Official eligibility criteria

Inclusion Criteria: A. Female, at least 18 years old B. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion * Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial. C. Patients who have previously received endocrine therapy should have a washout period of at minimum 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial D. Bilateral mammogram performed within up to 6 months (180 days) of the start of trial treatment may be used for screening evaluation. If a bilateral mammogram has been performed within 1 year (12 months) of the start of trial treatment, then a diagnostic unilateral mammogram within 6 months (180 days) of the start of trial treatment will be acceptable for screening evaluation. E. MRI performed on an I SPY (RECAST) approved scanner within 2 months (60 days) of the start of trial treatment for lesion evaluation may be used for screening evaluation. F. CBC w/ diff, CMP, and Lipid Panel within normal limits within a year of the start of trial treatment. Abnormal labs to be repeated within 60 days prior to the start of trial treatment. Patients will be considered eligible for screening labs that are abnormal or out-of-range if the investigator has deemed the lab results not-clinically significant G. Negative urine or serum pregnancy test within 1 month of the start of trial treatment H. Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent I. Willingness and ability to provide tumor samples for research Exclusion Criteria: A. Pregnant or actively breastfeeding women B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history C. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer D. Co-enrollment in clinical trials of pharmacologic agents requiring an IND E. Ongoing treatment for DCIS other than what is specified in this protocol F. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements G. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A/B/C\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures \*Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C antibody result, and quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay) H. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment I. Participants with substantial MRI artifacts (e.g., related to localizer sequences, cardiac devices such as pacemakers, or other hardware) that render the lesion non-evaluable. J. Severe allergy or reaction history to MRI contrast. K. Participants currently undergoing or who have received treatment for another malignancy within the previous 6 months.

Study sites (29)

CA

DC

FL

GA

IL

MN

NC

NJ

NY

PA

TN

UT

VA