BREAST: Metastatic: ER+, HER2neg, 1st line: BO41843

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

Title
Roche BO41843 (Breast 1st line ER+)
Study 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

Site Link
Malignancy
Breast cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st line (pre-chemo)
Investigational Agent
GDC-9545
Drug Class
Selective estrogen receptor degrader (SERD)
PI
Greg Vidal, MD, PhD
Sponsor
Hoffmann-LaRoche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Postmenopausal or pre-menopausal but treated with LHRH agonist therapy for the duration of study treatment
  • Locally advanced or metastatic adenocarcinoma of the breast not curable
  • Documented ER-positive and HER2-negative
  • No prior systemic anti-cancer therapy for metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No disease recurrence within 12 months of treatment with an AI or a CDK4/6 inhibitor in adjuvant/neoadjuvant setting
  • No prior SERD
  • No active CNS disease
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • ORR
    • DOR
    • CBR
    • Deterioration in pain level and physical functioning
    • Safety
    • PK
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
ER+ (positive), HER2 - (negative)
Dosing Frequency
Control Agents
AI, palbociclib
Study Protocol
Randomized
Yes
X