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Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer

NCT02506556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-08-16

No results posted yet for this study

Summary

This is a phase II, exploratory, open-label, single arm study of BYL719 monotherapy, a selective phosphatidylinositol 3-kinase (PI3K) alpha inhibitor, in adult patients with advanced metastatic breast cancer progressing after first line therapy. Patients with advanced hormone receptor positive tumors will be required to have an alteration of the PI3K pathway. Those patients with advanced triple negative breast cancers are genetically unselected for this study.

Conditions

Interventions

DRUG

BYl719

Treatment: BYL719 350mg orally daily Treatment will be given daily until progression, undue adverse events or withdrawal of consent. Dose reductions (two levels) are allowed. Each cycle is 28 days

Sponsors & Collaborators

Principal Investigators

  • Sherene Loi, MD,PhD · Peter MacCallum Cancer Centre, East Melbourne, Victoria, AUSTRALIA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-07
Primary Completion
2021-10-26
Completion
2021-10-26

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506556 on ClinicalTrials.gov