PIKNIC : 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 Breast Cancer Progressing After First Line Therapy.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase II trial is investigating the oral drug BYL719 as a monotherapy for people with advanced metastatic breast cancer after first line treatment.
 

This trial is treating patients with breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

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 Breast Cancer Progressing After First Line Therapy.

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

Summary

The primary purpose of this study is to determine whether BYL719, an oral selective PI3K alpha specific inhibitor, is a safe and effective drug treatment for adult patients with advanced breast cancer who have progressed after first line anti-cancer therapy. Patients who enrol in this study are required to have their breast cancer genetically characterised so we can understand the mutational profiles of their tumor. Who is it for? You may be eligible to join this study if you are over 18 years old, male or female, with advanced metastatic or locally recurring breast cancer which has progressed after first line therapy. It is a requirement of the study that some of your tumor tissue will evaluated in the laboratory for genetic alterations in their DNA. Regular blood tests will also be required to try to understand if we can detect the breast cancer's abnormal DNA in the blood. Study details All participants enrolled in this study will take the study drug, BYL719, which is an oral selective PI3K alpha specific inhibitor. Dose will commence at 350mg orally daily. This will involve taking tablets daily. Even though the study medication is taken daily, cycles are considered every 4 weeks. Visits to the Oncologist will be required every 4 weeks. Study medication will be continued until disease progression, unacceptable toxicity or requirement for new anti-cancer therapy. Participants will attend regular follow-up visits for up to 2 years in order to evaluate objective response rate, clinical benefit rate, progression free survival, safety and tolerability of treatment. Regular CT and/ or bone scans as well as blood tests will be performed. There will be two cohorts of participants involved in this study – those with advanced/ metastatic TNBC and those with advanced/metastatic ER+/HER2- breast cancers with a genetic mutation in the PI3K pathway. We plan to evaluate the efficacy and safety of BYL719 in these patients and associations with genetic features in order to try to identify biomarkers that can indicate those breast cancers more likely to respond to the study medication. *Patients are defined as “PI3K abnormal” if they have documented gene mutation in AKT1,2,3,ALK, EGFR, ERBB2,3,4, HRAS, INPP4B, KRAS, NRAS, PTEN, PIK3CA, PIK3R1, PIK3R3, PTEN or gene amplification in EGFR, PIK3CA, PIK3R1 or loss in PTEN and INPP4B as per a next generation targeted gene sequencing panel

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140