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

Last updated: April 27, 2025
Sponsor: QuantumLeap Healthcare Collaborative
Overall Status: Active - Recruiting

Phase

2

Condition

Genitourinary Cancer

Precancerous Condition

Breast Cancer

Treatment

Elacestrant

Testosterone + Anastrazole

TBD1

Clinical Study ID

NCT06075953
RECAST-DCIS
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female, at least 18 years old

  • previous diagnosis of Hormone Receptor positive (HR+) DCIS (at least 50% ER or PRand 2+; biopsy will have been performed previously at diagnosis) with or withoutmicroinvasion

  • Informed consent provided by the patient

  • Willingness and ability to provide tumor samples for research

Exclusion

Exclusion Criteria:

  • Pregnant or actively breastfeeding women (must be documented by a pregnancy testduring screening)

  • History of allergic reactions attributed to compounds of similar chemical orbiologic composition to study agent based on review of the medical record andpatient history.

  • Invasive carcinoma or identification of a mass on MRI that is subsequently biopsiedand found to be invasive cancer

  • Co-enrollment in clinical trials of pharmacologic agents requiring anInvestigational new Drug Appilcation (IND)

  • Ongoing treatment for DCIS other than what is specified in this protocol

  • Uncontrolled intercurrent illness, including psychiatric conditions, that wouldlimit compliance with study requirements.

  • Medical history or ongoing gastrointestinal disorders potentially affecting theabsorption of investigational agent and/or tamoxifen. Participants unable to swallownormally or unable to take tablets and capsules. Predictable poor compliance to oraltreatment. Active inflammatory bowel disease or chronic diarrhea, known activehepatitis A/B/C*, hepatic cirrhosis, short bowel syndrome, or any uppergastrointestinal surgery including gastric resection or banding procedures.

Study Design

Total Participants: 400
Treatment Group(s): 10
Primary Treatment: Elacestrant
Phase: 2
Study Start date:
February 14, 2024
Estimated Completion Date:
November 30, 2033

Study Description

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. The current management of most patients with DCIS involves surgical intervention with or without radiation, similar to more aggressive breast cancers. These treatments can come with some significant health effects.The main question this study aims to answer is: to determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance.

Participants will be asked to take one of three investigational study medication (z-Elacestrant, Testosterone + Anastrazole, or Endoxifen) or receive control hormonal therapy (Tamoxifen or an aromatase inhibitor), depending on the treatment to which they have been randomized. 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, with follow up evaluations of Mammogram and MRI at 6 month intervals. 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.

Participants will be followed annually for 10 years.

Connect with a study center

  • Berkeley Outpatient Center

    Berkeley, California 94158
    United States

    Active - Recruiting

  • UCSF

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania 19010
    United States

    Active - Recruiting

  • Riddle Hospital

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • Paoli Hospital

    Paoli, Pennsylvania 19301
    United States

    Active - Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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