Study on Active Monitoring and Hormonal Therapy for Early Stage Breast Cancer (DCIS)

Sponsor: QuantumLeap Healthcare Collaborative

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06075953

Provider View

This clinical trial is exploring whether active monitoring and hormonal therapy can effectively manage ductal carcinoma in situ (DCIS), an early form of breast cancer. Participants will receive either standard or investigational hormonal treatments and undergo regular evaluations to determine if surgery is necessary.

Patient Parameters

Program Overview

The aim of this study is to find out if monitoring and hormonal therapy can be a good way to manage ductal carcinoma in situ (DCIS), which is an early stage of breast cancer. Participants will receive either standard hormonal therapy or a new investigational hormonal treatment. They will have MRI evaluations at three and six months to check the progress. Depending on the results, participants may continue with the treatment or may need surgery. Participants will also provide blood and saliva samples for research purposes and tissue samples if surgery is performed.

Description

This study is looking at whether active monitoring and hormonal therapy can be a good way to manage ductal carcinoma in situ (DCIS), an early stage of breast cancer. Currently, most patients with DCIS undergo surgery, sometimes with radiation, similar to more aggressive breast cancers, which can have significant health effects. This study aims to see if new hormonal therapies can increase the number of patients who can be managed with long-term monitoring instead of immediate surgery.

Participants will be randomly assigned to take one of three investigational medications (z-Elacestrant, Testosterone + Anastrazole, or Endoxifen) or standard hormonal therapy (Tamoxifen or an aromatase inhibitor). They will have MRI evaluations at three and six months. Based on these evaluations, participants may continue with the treatment and have follow-up evaluations every six months. If surgery is recommended, participants will stop the study treatment and undergo surgery.

In addition to treatment and MRI evaluations, participants will:

  • Provide a blood sample to check their immune status
  • Provide a saliva sample for genetic testing
  • Provide tissue samples from any surgery performed as part of their standard care

Participants will be followed annually for 10 years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Female, at least 18 years old
  • Previously diagnosed with hormone receptor-positive (HR+) DCIS, with or without microinvasion
  • Able to provide informed consent
  • Willing to provide tumor samples for research

Exclusion Criteria

  • Pregnant or breastfeeding women
  • History of allergic reactions to similar compounds as the study medication
  • Invasive cancer found during MRI that requires biopsy
  • Participation in other clinical trials requiring new drug applications
  • Receiving other treatments for DCIS not specified in this study
  • Uncontrolled illnesses, including psychiatric conditions, that affect study participation
  • Medical history or ongoing gastrointestinal issues affecting absorption of medication
  • Inability to swallow pills or tablets
  • Active inflammatory bowel disease, chronic diarrhea, active hepatitis, liver cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery

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