Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Laura Esserman, MD
Headshot of Laura Esserman
Laura Esserman

Description

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.

Official Title

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

Details

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.

Keywords

Ductal Carcinoma in Situ, active surveillance, hormone therapy, endocrine therapy, Carcinoma, Carcinoma in Situ, Ductal Carcinoma, Carcinoma, Intraductal, Noninfiltrating, Tamoxifen, Letrozole, Exemestane, Anastrozole, Testosterone, Anastrazole, Testosterone + Anastrazole, Elacestrant, Z-endoxifen, Testosterone + Anastrazole (T+Ai), Endoxifen

Eligibility

You can join if…

Open to females ages 18 years and up

  • Female, at least 18 years old
  • previous diagnosis of Hormone Receptor positive (HR+) DCIS (at least 50% ER or PR and 2+; biopsy will have been performed previously at diagnosis) with or without microinvasion
  • Informed consent provided by the patient
  • Willingness and ability to provide tumor samples for research

You CAN'T join if...

  • Pregnant or actively breastfeeding women (must be documented by a pregnancy test during screening)
  • 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.
  • Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
  • Co-enrollment in clinical trials of pharmacologic agents requiring an Investigational new Drug Appilcation (IND)
  • Ongoing treatment for DCIS other than what is specified in this protocol
  • Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements.
  • Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Participants unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance to oral treatment. 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.

Locations

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Berkeley Outpatient Center accepting new patients
    Berkeley California 94158 United States

Lead Scientist at UCSF

  • Laura Esserman, MD
    Dr. Laura Esserman, M.D., M.B.A is a surgeon and breast cancer oncology specialist practicing at the UCSF Breast Care Center where she has also held the position of Director since 1996. She co-leads the Breast Oncology Program, the largest of the UCSF Helen Diller Comprehensive Cancer Center's multidisciplinary programs.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
QuantumLeap Healthcare Collaborative
ID
NCT06075953
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated