West Cancer Center

Breast: HER2+: METASTATIC: 2nd line or later: Brain mets: BREnnA

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases

Title

Roche WO46069 Breast HER2+ BREnnA

Study Title

Site Link

NCT07413939

Malignancy

Breast cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line or later

Investigational Agent

RO7771950

Drug Class

HER2 TKI

Greg Vidal, MD, PhD

Sponsor

Roche Genentech

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Locally advanced inoperable or metastatic breast cancer with confirmed HER2-positive status
Measurable disease
Previously treated or previously untreated CNS mets or leptomeningeal disease
Prior anti-HER2 ADC in any treatment setting
Prior TKI in neo or adjvuant setting is allowed provided completion was >12 months before recurrence
LVEF >50%
No known HBV/HCV

Objective

Primary
- PFS
Secondary
- Brain met specific PFS
- OS
- ORR
- DOR
- CBR
- CNS ORR
- CNS DOR
- CNS CBR
- Safety
- QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Breast cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes