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Protocol No. UW19035

Principal Investigator Wisinski, Kari

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title An Open-Label Randomized Phase 2 trial of SAR439859, versus Endocrine Monotherapy as per Physician's Choice in Patients with Estrogen Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer with Prior Exposure to Hormonal Therapies

Objective The purpose of the study is to assess the safety and treatment benefit of SAR439859 (experimental hormonal treatment not yet marketed) compared with other commercially available hormonal treatments (control treatments) approved for locally advanced or metastatic breast cancer and prescribed by your study doctor for treatment of your disease

This is a randomized, so you will be randomly assigned (like drawing straws) to receive either SAR439859 (4 capsules by mouth each day in the morning with or without food) or other hormonal treatments already approved for breast cancer and at your study doctor's choice

Description An open-label randomized Phase 2 trial of SAR439859, versus endocrine monotherapy as per physician’s choice in premenopausal and postmenopausal patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with prior exposure to hormonal therapies

Key Eligibility
  • 18 years of age or older
  • Histological or cytological proven diagnosis of adenocarcinoma of the breast
  • Participants with evidence of either locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease
  • Documentation of ER-positive (greater than or equal to 1% positive stained cells) based on most recent tumor cell staining by immunohistochemistry (IHC) assay consistent with local standards. Note that if the primary tumor is ER-positive and any further metastatic lesion is ER-negative, the participant cannot be selected for inclusion
  • Either the primary tumor or any metastatic site must be HER2 non over-expressing by IHC(0, 1+), or in situ hybridization-negative based on single-probe average HER2 copy number as per AmericanSociety of Clinical Oncology guidelines
  • For patients with tumor accessible for paired biopsy at study entry: baseline samples, formalin-fixed paraffin-embedded (FFPE) archived biopsy samples (within 3 months prior initiation of study treatment) can be used, but preferably fresh biopsies from primary tumor or recurrence or metastasis, will be collected. It is recommended that the second biopsy is collected at the same location as the baseline biopsy, whenever possible
  • Prior chemotherapy (including antibody-drug conjugates) or targeted therapy (eg, as CDK4/6 inhibitors) is allowed: participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease. Participants who received both prior chemotherapy and targeted therapy are not allowed
  • Must have progressed after at least 6 months of a continuous prior endocrine therapy for advanced breast cancer (single agent or in combination, the number of hormonal lines is not limited), or have progressed within 12 months of completion of adjuvant endocrine therapy
  • Must be postmenopausal women as defined by the protocol
  • ECOG performance status of 0-2
  • Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of oral IMP. Participants unable to swallow normally and to take capsules
  • Life expectancy less than 3 months
  • Bone-only metastasis (bone-only metastasis was defined as bone metastasis without evidence of involvement of any other organ)
  • Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
  • Prior treatment with any other SERD compound, except fulvestrant if stopped for at least 3 months before randomization
  • Treatment with atazanavir, lopinavir (antiviral agents), ketoconazole (antifungal), and quercetin (antioxidant) less than 2 weeks before randomization or 5 elimination half-lives whichever is longer
  • Inadequate hematological, renal or liver function as defined by the protocol
  • Prothrombin time/international normalized ratio (INR) greater than 1.5 times the upper limit of normal (ULN) or outside therapeutic range if receiving anticoagulation that would affect the prothrombin time/INR

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics