Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2- negative aBC, with PIK3CA mutations, whose disease has progressed on or after prior treatments

Phase 1

• Conditions: Hormone receptor positive, HER2-negative advanced breast cancer; MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004586-67-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-14
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

- Patient is male or female 18 years or older
- Males or females with advanced (locoregionally recurrent or metatstatic) breast cancer not amenable to curative therapy
- Patient is identified PIK3CA mutant status
- In case of women, both premenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin or leuprolide to be used concomitantly with alpelisib in combination with fulvestrant or letrozole.
- Patient has confirmed HER2-negative advanced breast cancer (aBC)
-Patient must be diagnosed with aBC with documented progression on or after CDK 4/6 treatment (adjuvant or metastatic setting)
- Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
- Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
- ECOG function of greater or equal to 2
- Patient has adequate bone marrow function
- Patient has adequate liver and renal function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

- Patient has a known hypersensitivity to alpelisib, fulvestrant, letrozole, goserelin or leuprolide to any of the excipients of alpelisib, fulvestrant, letrozole, goserelin or leuprolide.
- patient has received prior treatment with any PI3K inhibitors
- patient with with an established diagnosis of diabetes mellitus type I or
uncontrolled type II
- patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
-Patient 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-melanoma skin cancer or curatively resected cervical cancer
-Patient has received radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
-History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
-Bilateral diffuse lymphangitis carcinomatosis
-Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
• At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
• Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as
determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
-Patient with severe liver impairment (Child Pugh score B/C)
-Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
-Patient has documented pneumonitis which is active and requiring treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified