Clinical Trial 23678

• Overview

  Study Title:

  DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a breast cancer prevention pilot 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.

  Objective:

  Primary Objective: - To determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance Secondary Objectives: - To determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance as measured by the fraction of patients deemed to be low risk for invasive cancer after 6 months compared to control - To determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance as measured by the fraction of patients deemed to be low risk for invasive cancer after 3 months compared to control - Associate rate of progression of IDC with risk categorization after 6 months of treatment at 3 years - To assess the QOL impact of novel endocrine therapy compared to tamoxifen or AI at standard or low dose using PROMIS and the FACTES composite score compared to control - For those with an identified lesion on MRI imaging, determine whether neoadjuvant endocrine therapy decreases lesion volume (qualitative, quantitative) and whether that corresponds to the biologic type of DCIS - To determine whether neoadjuvant endocrine therapy decreases automated BPE and automated MRI density compared to AI and Tamoxifen - Determine adherence to active surveillance protocol - Change in artificial intelligence-predicted risk based on mammography

• Treatments

  Therapies:

  Anti-estrogen and PKCB1 inhibitor; Hormonal Therapy; Selective estrogen receptor degrader, SERD; Selective estrogen receptor modulator (SERM); non-steroidal aromatase inhibitor

  Medications:

  Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Elacestrant (); Exemestane (); Femara (Letrozole); Letrozole (); Tamoxifen (); Testosterone + Anastrozole (); Z-endoxifen ()

• Inclusion Criteria

  Inclusion Criteria:
  • Female, at least 18 years old
  • Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion
  • Patients who have previously received endocrine therapy should have a washout period of 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial
  • Bilateral mammogram performed within up to 4 months (120 days) of the start of trial treatment may be used for screening evaluation
  • MRI performed within up to 2 months (60 days) of the start of trial treatment for lesion evaluation
  • 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
  • Negative urine or serum pregnancy test within 1 month of the start of trial treatment
  • Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent
  • Willingness and ability to provide tumor samples for research

• Exclusion Criteria

  Exclusion Criteria:
  • Pregnant or actively breastfeeding women
  • 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 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. 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)
  • Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment

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