RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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

Quick Facts

Study Start:2024-02-14
Study Completion:2033-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06075953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, at least 18 years old
  2. * 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
  3. * Informed consent provided by the patient
  4. * Willingness and ability to provide tumor samples for research
  1. * Pregnant or actively breastfeeding women (must be documented by a pregnancy test during screening)
  2. * 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.
  3. * Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
  4. * Co-enrollment in clinical trials of pharmacologic agents requiring an Investigational new Drug Appilcation (IND)
  5. * Ongoing treatment for DCIS other than what is specified in this protocol
  6. * Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements.
  7. * 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.

Contacts and Locations

Study Contact

Ami Okada, PhD MBA
CONTACT
+1 (415) 610-7011
a.okada@quantumleaphealth.org
Maria Pitsiouni, PhD
CONTACT
(415) 651-8047
m.pitsiouni@quantumleaphealth.org

Study Locations (Sites)

Berkeley Outpatient Center
Berkeley, California, 94158
United States
UCSF
San Francisco, California, 94158
United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
United States
Riddle Hospital
Media, Pennsylvania, 19063
United States
Paoli Hospital
Paoli, Pennsylvania, 19301
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: QuantumLeap Healthcare Collaborative

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-14
Study Completion Date2033-11

Study Record Updates

Study Start Date2024-02-14
Study Completion Date2033-11

Terms related to this study

Keywords Provided by Researchers

  • active surveillance
  • hormone therapy
  • endocrine therapy

Additional Relevant MeSH Terms

  • Ductal Carcinoma in Situ