Giredestrant + Palbociclib vs Letrozole + Palbociclib for Breast Cancer

Recruiting in Palo Alto (17 mi)

+488 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Eligibility Criteria

This trial is for adults with ER-positive, HER2-negative advanced or metastatic breast cancer who haven't had systemic anti-cancer therapy for their advanced disease. They should have completed at least 24 months of standard adjuvant endocrine therapy without progression and be over a year since the last treatment. Pre/peri-menopausal women and men must use LHRH agonist therapy.

Inclusion Criteria

I am fully active or can carry out light work.

I am receiving hormone therapy to manage my cancer.

I have cancer that can be measured by scans or have a specific type of bone lesion.

+6 more

Exclusion Criteria

Pregnant or breastfeeding

Treatment with any investigational therapy within 28 days prior to study treatment

My cancer has spread to vital organs and poses an immediate risk to my life.

+5 more

Participant Groups

The study compares the effectiveness and safety of two treatments: Giredestrant combined with Palbociclib versus Letrozole combined with Palbociclib. It's a Phase III trial where participants are randomly assigned to either treatment in a double-blind manner, meaning neither they nor the researchers know which group they're in.

2Treatment groups

Experimental Treatment

Active Control

Group I: Giredestrant + Letrozole-matched Placebo + PalbociclibExperimental Treatment4 Interventions

Group II: Letrozole + Giredestrant-matched Placebo + PalbociclibActive Control4 Interventions