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Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade

NCT06068985 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-02-12

No results posted yet for this study

Summary

This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO™ (pertuzumab and trastuzumab) without chemotherapy. The approach involves utilizing specific biomarkers (HR and HER2 IHC status) to select participants whose tumors strongly rely on the HER2 pathway, potentially benefiting from a HER2-targeted approach without chemotherapy concurrently.

Conditions

Interventions

DRUG

PHESGO

Subcutaneous formulation with pertuzumab and trastuzumab.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Oncoclínicas

    collaborator INDUSTRY

  • Latin American Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Sérgio Simon · Oncoclínicas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2026-04-30
Completion
2032-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06068985 on ClinicalTrials.gov