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
- Berkeley Outpatient Center · Berkeley, CA 94158Niloufar Abdollahi · Study contact · 415.476.3322 · Niloufar.abdollahi@ucsf.eduDasha Peiris · Study contact · 415-533-0141 · Dasha.Peiris@ucsf.eduJordan Jackson, MD · Principal investigatorMore trials in Berkeley
- City of Hope -Duarte Cancer Center · Duarte, CA 91010Mellissa Henry, RN, MSN, FNP-C · Study contact · 626-713-8895 · mehenry@coh.orgJennifer Tseng, MD · Principal investigatorMore trials in Duarte
- City of Hope - Lennar Foundation Cancer Center · Irvine, CA 92618Mellissa Henry, RN, MSN, FNP-C · Study contact · 626-713-8895 · mehenry@coh.orgJennifer Tseng, MD · Principal investigatorMore trials in Irvine
- UCLA · Los Angeles, CA 90095Sophia Quiroz, Clinical Research Coordinator · Study contact · 310-794-0130 · SQuiroz@mednet.ucla.eduMediget Teshome, MD · Principal investigatorMore trials in Los Angeles
- UCSF · San Francisco, CA 94158Dasha Peiris · Study contact · 415-533-0141 · Dasha.Peiris@ucsf.eduJordan Jackson, MD · Principal investigatorMore trials in San Francisco
- City of Hope · South Pasadena, CA 91030Mellissa Henry, RN, MSN, FNP-C · Study contact · 626-713-8895 · mehenry@coh.orgJennifer Tseng, MD · Principal investigatorMore trials in South Pasadena
- John Muir Health · Walnut Creek, CA 94598Jen Johnson, Clinical Research Coordinator · Study contact · 925-674-2580 · Jen.Johnson@johnmuirhealth.comMonica Eigelberger, MD · Principal investigatorMore trials in Walnut Creek
DC
- MedStar Washington Hospital Center · Washington D.C., DC 20010Hiwot Guebre-Xabiher, Research Manager · Study contact · 202-877-8839 · Hiwot.Guebre-Xabiher@medstar.netMarc Boisvert, MD · Principal investigatorMore trials in Washington D.C.
FL
- Moffitt Cancer Center · Tampa, FL 33612Neveen Abdo, Clinical Research Coordinator · Study contact · 727-748-9345 · Neveen.abdo@moffitt.orgLaura Kruper, MD · Principal investigatorMore trials in Tampa
GA
- Winship Cancer Institute, Emory University · Atlanta, GA 30322Winship Clinical Trials Office · Study contact · 1-404-778-1868 · winshipcto@emory.eduTrisha Burrello · Study contact · trisha.n.burrello@emory.eduClara Farley, MD · Principal investigatorMore trials in Atlanta
IL
- University of Chicago Medical Center · Chicago, IL 60637Vhenyse Encarnacion · Study contact · vhenyse.encarnacion@bsd.uchicago.eduBetty Fan, MD · Principal investigatorMore trials in Chicago
MN
- Maple Grove Cancer Center · Maple Grove, MN 55369Oncology Access Nurse · Study contact · 612-624-2620 · ccinfo@umn.eduJane Hui, MD · Principal investigatorMore trials in Maple Grove
- Hennepin Healthcare -Minneapolis · Minneapolis, MN 55404Hannah Merrill · Study contact · 952-993-0996 · hannah.merrill@parknicollet.comNiki Hoese · Study contact · 952-993-1585 · nicole.hoese@parknicollet.comSatya Bommakanti, MD · Principal investigatorMore trials in Minneapolis
- University of Minnesota · Minneapolis, MN 55455Oncology Access Nurse · Study contact · 612-624-2620 · ccinfo@umn.eduJane Hui, MD · Principal investigatorMore trials in Minneapolis
- Health Partners - Frauenshuh Cancer Center · Saint Louis Park, MN 55426Hannah Merrill · Study contact · 952-993-0996 · hannah.merrill@parknicollet.comNiki Hoese · Study contact · 952-993-1585 · nicole.hoese@parknicollet.comRachel Lerner, MD · Principal investigatorMore trials in Saint Louis Park
- Health Partners - Regions Hospital · Saint Paul, MN 55101Hannah Merrill · Study contact · 952-993-0996 · hannah.merrill@parknicollet.comNiki Hoese · Study contact · 952-993-1585 · nicole.hoese@parknicollet.comRachel Lerner, MD · Principal investigatorMore trials in Saint Paul
NC
- Duke Cancer Institute · Durham, NC 27710Breast Cancer Study Team · Study contact · 919-660-1278 · breastcl@dm.duke.eduTon Wang, MD · Principal investigatorMore trials in Durham
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center · Winston-Salem, NC 27157Brandy Baker and Lindsy Davis, RN · Study contact · 336-716-8941 OR 336-716-6748 · brandy.baker@advocatehealth.org, lindsey.davis@advocatehealth.orgSydney McEntire · Study contact · sydney.mcentire@advocatehealth.orgMarissa Howard-McNatt, MD · Principal investigatorMore trials in Winston-Salem
NJ
- Englewood Hospital and Medical Center · Englewood, NJ 07631Kayla Williams · Study contact · 201-894-3000 ext. 9786 · kayla.williams@ehmchealth.orgJennifer Marti, MD · Principal investigatorMore trials in Englewood
NY
- Mount Sinai Union Square · New York, NY 10003Contact: Site Public Contact · Study contact · 212-824-7309 · CRSU@mssm.eduTara Balija, MD · Principal investigatorMore trials in New York
- Mount Sinai Chelsea · New York, NY 10011Contact: Site Public Contact · Study contact · 212-824-7309 · CRSU@mssm.eduTara Balija, MD · Principal investigatorMore trials in New York
- Mount Sinai West · New York, NY 10019Contact: Site Public Contact · Study contact · 212-824-7309 · CRSU@mssm.eduTara Balija, MD · Principal investigatorMore trials in New York
- Icahn School of Medicine at Mount Sinai · New York, NY 10029Contact: Site Public Contact · Study contact · 212-824-7309 · CRSU@mssm.eduTara Balija, MD · Principal investigatorMore trials in New York
PA
- Bryn Mawr Hospital · Bryn Mawr, PA 19010More trials in Bryn Mawr
- Paoli Hospital · Paoli, PA 19301More trials in Paoli
- Lankenau Medical Center · Wynnewood, PA 19096More trials in Wynnewood
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Oncology nursing · Study contact · 1-800-811-8480 · cip@vumc.orgJennifer Goodman, RN, BSN · Study contact · 615.936.6825 · jennifer.e.goodman@vumc.orgIngrid Meszoely, MD · Principal investigatorMore trials in Nashville
UT
- Huntsman Cancer Institute · Salt Lake City, UT 84112Janna Espinosa · Study contact · 801-585-0571 · Janna.Espinosa@hci.utah.eduKirstyn Brownson, MD · Principal investigatorMore trials in Salt Lake City
VA
- Virginia Commonwealth University · Richmond, VA 23298Massey CTO Breast Team · Study contact · 804-628-6430 · masseyctbrst@vcu.eduKandace McGuire, MD · Principal investigatorMore trials in Richmond