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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
Overall Recruitment Status: Active, currently enrolling
 
Official Title
BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments
 
Region Sponsors
California - Southern
Novartis Foundation
 
Acronym KP IRB No.
(BYLieve) 11459
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Older Adult) with Breast Cancer
 
Purpose
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
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
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
  • 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 (examples for use in this study include but not limited to goserelin, leuprolide or locally available treatment) to be used concomitantly with alpelisib and letrozole/fulvestrant
  • Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
  • Patient has confirmed HER2-negative advanced breast cancer (aBC)
  • Patient has a PIK3CA mutation confirmed by Novartis designated central lab or patient has a pathology report confirming PIK3CA mutant status by certified laboratory (using validated PI3KCA mutation assay) either from tissue or blood and must (mandatory) send tumor tissue to Novartis designated central lab for confirmation of mutational status
  • Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present ECOG performance status = <2
  • Patient has fasting plasma glucose (FPG) = <140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) = <6.4% (both criteria have to be met)
  • Patient has adequate bone marrow, coagulation, liver and renal function
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • Patient has known hypersensitivity to alpelisib, fulvestrant or letrozole
  • Patient has received prior treatment with any PI3K inhibitors
  • Patient 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
  • 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
  • Patient has a history of Stevens-Johnson-Syndrome (SJS) or Toxic Epidermal Necroloysis (TEN)
  • Patient is concurrently using other anti-cancer therapy. All anti-cancer therapy must be discontinued prior to day one of study treatment.
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Antineoplastic Agents
  • Hormone Antagonists
  • Antineoplastic Agents, Hormonal
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Aromatase Inhibitors
  • Letrozole
  • Breast Cancer
  • Leuprolide
  • Breast Diseases
  • Molecular Mechanisms of Pharmacological Action
  • Breast Neoplasms
  • Neoplasms
  • Enzyme Inhibitors
  • Neoplasms by Site
  • Estrogen Antagonists
  • Physiological Effects of Drugs
  • Estrogen Receptor Antagonists
  • Reproductive Control Agents
  • Fertility Agents
  • Skin Diseases
  • Fertility Agents, Female
  • Steroid Synthesis Inhibitors
  • Fulvestrant
  • Oncology (Adult)
  • Goserelin
 
KP Clinical Facility
  • Anaheim
  • Antelope MOB
  • Baldwin Park
  • Bellflower
  • Carlsbad
  • Edgemont MOB
  • Fontana
  • Garfield Specialty Center
  • Harbor City
  • Irvine
  • Lancaster MOB
  • Los Angeles (Sunset)
  • Panorama City
  • Pasadena
  • Riverside
  • San Diego
  • San Marcos
  • Southern California
  • Sunset-Vermont MOB
  • West LA
  • Woodland Hills
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Lara Durna, MD
Contact Information:
- Clinical.Trials@kp.org
-Pasadena


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