NCT04546009 : A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy,Treatment | BreastBreast

Trial Overview Read MoreRead more

This phase III trial is comparing the safety and effectiveness of two oral hormone therapy drugs in patients with ER+, HER2- breast cancer that has spread locally or to other parts of the body.
 

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 may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Commercial Sponsor

Hoffmann-La Roche

Summary

Eligible patients will be randomly selected to receive oral GDC-9545 or oral Letrozole once per day on Days 1-28 of each 28-day treatment cycle, plus 125mg Palbociclib once per day on Days 1-21 of each 28-day treatment cycle. Patients that are premenopausal or male will also receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle, as determined and supplied by the investigator.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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