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Could hormone pills replace surgery for some early breast cancers?

NCT ID NCT06075953

Disease control Sponsor: QuantumLeap Healthcare Collaborative Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests whether active surveillance (close monitoring) combined with hormonal therapy can safely manage ductal carcinoma in situ (DCIS), a very early form of breast cancer. About 400 women with hormone-positive DCIS will receive either standard or investigational hormone therapy and undergo MRI scans at 3 and 6 months. If the scans show low risk, they may continue monitoring instead of immediate surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Nov 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ductal breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ductal carcinoma in situ

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Berkeley Outpatient Center

    RECRUITING

    Berkeley, California, 94158, United States

  • Bryn Mawr Hospital

    ACTIVE_NOT_RECRUITING

    Bryn Mawr, Pennsylvania, 19010, United States

  • City of Hope

    RECRUITING

    South Pasadena, California, 91030, United States

  • City of Hope - Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope -Duarte Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Englewood Hospital and Medical Center

    RECRUITING

    Englewood, New Jersey, 07631, United States

  • Health Partners - Frauenshuh Cancer Center

    RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • Health Partners - Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Hennepin Healthcare -Minneapolis

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • John Muir Health

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Lankenau Medical Center

    ACTIVE_NOT_RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Maple Grove Cancer Center

    RECRUITING

    Maple Grove, Minnesota, 55369, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Mount Sinai Chelsea

    RECRUITING

    New York, New York, 10011, United States

  • Mount Sinai Union Square

    RECRUITING

    New York, New York, 10003, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

  • Paoli Hospital

    ACTIVE_NOT_RECRUITING

    Paoli, Pennsylvania, 19301, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

    Contact Email: •••••@•••••

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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