West Cancer Center

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

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

Site Link

NCT04546009

Malignancy

Breast cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st line (pre-chemo)

Investigational Agent

GDC-9545

Drug Class

Selective estrogen receptor degrader (SERD)

Greg Vidal, MD, PhD

Sponsor

Hoffmann-LaRoche

Phase

Phase 3

Status

Closed to Accrual

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