CTRI/2022/04/042205
Recruiting
Phase 4
A Phase IV, prospective, multicenter, open-label, non- comparative, interventional study to assess the safety of alpelisib plus fulvestrant, in men and post-menopausal women with HR-positive,HER2-negative, advanced or metastatic breast cancer (ABC or MBC) with a PIK3CA mutation, whose disease has progressed on or after endocrine treatment. - ALPINIST
ovartis Healthcare Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent obtained before any trial related activities and according to local guidelines.
- •2\. Participants with confirmed PIK3CA mutant ABC or MBC whose disease has progressed on or after endocrine based treatment
- •3\. Postmenopausal females and males more than or equal to 18 years old with confirmed HR positive HER2 negative advanced or metastatic breast cancer.
- •Postmenopausal status is defined either by:
- •i) Prior bilateral oophorectomy
- •ii) Age equal to or more than 60 y
- •iii) Age less than 60 y and amenorrheic for 12 or more months in the absence of chemotherapy tamoxifen toremifene or ovarian suppression and Follicle stimulating Hormone FSH and estradiol in the postmenopausal range per local normal range
- •Note: For women with therapy induced amenorrhea serial measurements of FSH andor estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone\-releasing hormone agonist LH\-RHa goserelin acetate or leuprolide acetate is not permitted for induction of ovarian suppression in this trial.
- •4\. Participant has adequate bone marrow and organ function that is considered appropriate to receive study treatment, as per the Investigator’s clinical judgement.
- •5\. Adequate liver function as shown by
Exclusion Criteria
- •1\. Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant
- •2\. Participant ineligible for endocrine therapy per the investigators judgment
- •3\. Participant has received prior treatment with any PI3K inhibitors and/or mTOR inhibitor
- •4\. Participant with type I diabetes or not controlled type II based on FPG and HbA1c see inclusion criterion 7
- •5\. Participant has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated basal or squamous cell carcinoma non melanomatous skin cancer or curatively resected cervical cancer
- •6\. Participant has not recovered to grade 1 or better from related side effects of prior anticancer therapy with the exception of alopecia
- •7\. Participants receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except in cases outlined below Topical applications inhaled sprays eye drops or local injections are allowed. Participants on stable low dose of corticosteroids for at least two weeks prior to enrollment are allowed
- •8\. Bilateral diffuse lymphangitic carcinomatosis
- •9\. Participants with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required
- •10\. Active, bleeding diathesis, or on oral anti\-vitamin K medication.
Outcomes
Primary Outcomes
Not specified
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