SANDPIPER : A phase III, double-blind, placebo-controlled, randomised study of taselisib plus Fulvestrant versus placeo plus Fulvestrant in postmenopausal women with oestrogen receptor-positive and HER2-negative locally advanced or metastatic breast cancer who have disease recurrence or progression during or after aromatase inhibitor therapy.

Female<br/>OnlyGender Female
Only

Closed (no longer recruiting)Status Closed (no longer recruiting)

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-75Age 18-75

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast,

Trial Overview Read MoreRead more

This phase III trial is evaluating a hormone therapy drug (fulvestrant) in combination with taselisib for the treatment of oestrogen receptor positive, HER 2 negative advanced or metastatic breast cancer.
 

This trial is treating patients with oestrogen receptor positive and HER 2 negative breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

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

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A phase III, double-blind, placebo-controlled, randomised study of taselisib plus Fulvestrant versus placeo plus Fulvestrant in postmenopausal women with oestrogen receptor-positive and HER2-negative locally advanced or metastatic breast cancer who have disease recurrence or progression during or after aromatase inhibitor therapy.

Commercial Sponsor

Hoffmann-La Roche

Summary

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

Not Recruiting Hospitals Read MoreRead more

Closed

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167