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Trial Summary

This is a combination Phase I and Phase II study, with an aim to evaluate the combination ofGSK 525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy.

Acronym:

GSK Breast

ACTRN/NCT /ethics:

NCT02964507

Scientific title:

A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer

Sponsor / Cooperative group:

GlaxoSmithKline

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase I, Phase II
Age Range18 years and older
SexFemale
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2017-02-02
Anticipated End Date2022-09-15

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlex Scott-Hoy
Emailalex.scott-hoy@sa.gov.au
Phone08 8204 4830
Principal InvestigatorProfessor Bogda Koczwara
Recruitment StatusRecruiting