A Study to Evaluate 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

Phase 1

• Conditions: Estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer; MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864

• Registration Number: EUCTR2020-000119-66-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 978

Inclusion Criteria

–Age >= 18 years at time of signing Informed Consent Form
–For women who are premenopausal or perimenopausal or men: treatment with approved LHRH agonist therapy for the duration of study treatment
–Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
–Documented ER-positive tumor and HER2-negative tumor, assessed locally
–No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
–Measurable disease as defined per RECIST v.1.1
–Eastern Cooperative Oncology Group Performance Status 0-1
–Adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 391
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 587

Exclusion Criteria

–Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an AI
–Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
–Prior treatment with a SERD
–Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen
–Treatment with any investigational therapy within 28 days prior to study treatment
–Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
–Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
–Active cardiac disease or history of cardiac dysfunction
–Pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified