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RO7771950

Phase 2

HER2-positive Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment650

FDA Designations

No designations recorded

Clinical trial landscape

RO7771950 · 1 trial · 1 indication

Phase 2 1
NCT07413939RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-PositiveHER2-positive Breast Cancer
RECRUITING650 Analytics
PHASE2RECRUITING
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR)
Approximately 35 months

Time from randomization to disease progression or death, according to standard criteria (Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)).

Secondary Endpoints

Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR
Approximately 35 months
Overall Survival in Full Analysis Set (OS-FAS)
Approximately 53 months
Objective Response Rate (ORR) by BICR
Approximately 35 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A - RO7771950 Dose Type 1EXPERIMENTAL -
Arm B - RO7771950 Dose Type 2EXPERIMENTAL -
Arm C - TucatinibACTIVE_COMPARATOR -

Interventions

NameTypeDescription
RO7771950DRUGParticipants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
TucatinibDRUGParticipants will receive a dose of tucatinib PO BID.
TrastuzumabDRUGParticipants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
CapecitabineDRUGParticipants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites186

Inclusion Criteria: * Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory. * Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2. * Previously treated (stab...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaCzechiaFranceGermanyHungaryIsraelItalyNew ZealandPolandPortugalSouth AfricaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07413939lastUpdatePostDate: changed
LOWSep 3, 2026NCT07413939lastUpdatePostDate: changed
LOWAug 5, 2026NCT07413939lastUpdatePostDate: changed

Frequently asked questions about RO7771950

What is RO7771950 used for in HER2-positive breast cancer?

RO7771950 is an investigational small molecule being studied for the treatment of HER2-positive breast cancer. It is currently in Phase 2 clinical development for people with locally advanced or metastatic HER2-positive breast cancer. The drug is being evaluated in combination with trastuzumab and capecitabine.

What does RO7771950 target?

RO7771950 is a small molecule being developed for HER2-positive breast cancer. The specific molecular target of RO7771950 has not been disclosed. It is being studied in combination with trastuzumab and capecitabine for the treatment of locally advanced or metastatic HER2-positive breast cancer.

Who makes RO7771950?

RO7771950 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is currently conducting a Phase 2 clinical trial of RO7771950 for HER2-positive breast cancer.

What phase is RO7771950 in?

RO7771950 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of HER2-positive breast cancer.

What clinical trials is RO7771950 in?

RO7771950 is being studied in one active Phase 2 clinical trial, NCT07413939. This trial compares RO7771950 versus tucatinib in combination with trastuzumab and capecitabine in people with locally advanced or metastatic HER2-positive breast cancer. The trial is recruiting participants across multiple countries.

Is RO7771950 the same as tucatinib?

No, RO7771950 is not the same as tucatinib. RO7771950 is an investigational drug being compared against tucatinib in a clinical trial. The trial, NCT07413939, evaluates RO7771950 versus tucatinib, both in combination with trastuzumab and capecitabine, for HER2-positive breast cancer.