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 CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant

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-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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 has histological and/or cytological confirmed ER+ and/or PgR+
aBC
- Patient has confirmed HER2-negative advanced breast cancer (aBC)
- Patient is identified PIK3CA mutant status
- In case of women, both premenopausal and postmenopausal patients
are allowed to be included in study; menopausal status is relevant for
the requirement of LHRH agonist
-Patient must have documented evidence of tumor progression on or after CDK 4/6 combination treatment
- Patient has either measurable disease per RECIST v1.1 or at least one
predominantly lytic bone lesion must be present
- Patient has adequate bone marrow function
- Patient has adequate liver and renal function
- ECOG function of greater or equal to 2
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

letrozole or to any of the excipients of alpelisib, fulvestrant or letrozole
- 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 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
-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
For all exclusion criteria, please refer to protocol section 5.3

Study & Design

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