Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have 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-NL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-25
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

- Patient is male or female 18 years or older
- Patient is identified PIK3CA mutant status
- Patient has confirmed HER2-negative advanced breast cancer (aBC)
-Patient must be diagnosed with aBC with documented progression on or after prior treatment
- 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 received prior treatment with any PI3K inhibitors
- 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
-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 based on
investigator discretion
-Patient has documented pneumonitis/interstitial lung disease which is active and requiring treatment
-Patient has a history of severe cutaneous reactions like Stevens Johnson-Syndrome (SJS), Erythema Multiforme (EM), or Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinphilia and Systemic Symptoms (DRESS)
-Subjects with unresolved osteonecrosis of the jaw

Study & Design

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