New study for patients with HR+ HER2- advanced breast cancer
- Trial ID:
- IRB-25-8587
- Paulette Gabbai-Saldate, MD MPH
Inclusion Criteria
Patients must:
- Be 18 years old at the time of signing the Informed Consent.
Have cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent.
Have documented ER + and/or PR + tumor.
Have documented HER2 - tumor (defined as a HER2 immunohistochemistry (IHC) score of 0 or 1+, or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating the absence of ERBB2 gene amplification, or a HER2/CEP17 ratio of <2.0 based on the most recent tumor biopsy.
Have de-novo HR+, HER2- advanced breast cancer (ABC), or relapsed HR+, HER2- ABC after at least 2 years of standard neodjuvant/adjuvant endocrine therapy without progression of the disease during that treatment and a disease-free interval of at least 1 year since the completion of that treatment. If a CDK4/6 inhibitor was included as part of that treatment, progression must not have occurr
Exclusion Criteria
Patients must not:
- Be committed to an institution.
Be pregnant or breastfeeding, or have the intention of becoming pregnant during the study.
Have metaplastic breast cancer.
Have had prior treatment with an investigational therapy.
Have radiotherapy within 2 weeks before randomization into the study.
Have any prior systemic therapy for locally advanced unresectable or metastatic breast cancer.
Have type 2 diabetes requiring ongoing systemic treatment, or any history of type 1 diabetes.
Have an Inability or unwillingness to swallow pills.
Have malabsorption syndrome or other conditions that would interfere with enteral absorption.
Have any history of leptomeningeal disease or carcinomatous meningitis.
Have known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control).
Be requiring daily supplemental oxygen.
Have symptomatic active lung disease.
Have active tuberculosis.
Have any history of
Additional Info
The study Sponsor, investigator, participant, Independent Review Facility, steering committee, and site personnel will be blinded. They will not know if the patient is receiving the study medication or placebo.