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A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)

NCT03988036 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-05-15

No results posted yet for this study

Summary

Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.

Conditions

Interventions

DRUG

Pembrolizumab

Intravenous infusion; 200 mg; every 3 weeks

DRUG

Trastuzumab Biosimilar ABP 980

Intravenous infusion; 8 mg/kg loading dose, thereafter 6 mg/kg; every 3 weeks

DRUG

Pertuzumab

Intravenous infusion; 840 mg/kg loading dose, thereafter 420 mg/kg; every 3 weeks

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • NanoString Technologies, Inc.

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03988036 on ClinicalTrials.gov