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OncoMatch/Clinical Trials/NCT06686394

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

Official title: HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Is NCT06686394 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments for breast neoplasms.

Phase 1/2RecruitingMerck Sharp & Dohme LLCNCT06686394Data as of Oct 2026Location: International · 6 countries

Treatment: Patritumab deruxtecan · Trastuzumab · Trastuzumab Biosimilar · Pertuzumab · Tucatinib — Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Patritumab deruxtecanTrastuzumabTrastuzumab BiosimilarPertuzumabTucatinib

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: her2-targeted tyrosine kinase inhibitor (tucatinib, lapatinib, neratinib)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Colorado Anschutz Medical Campus ( Site 0057) · Aurora, Colorado
  • Dana-Farber Cancer Institute ( Site 0050) · Boston, Massachusetts
  • Rutgers Cancer Institute of New Jersey ( Site 0052) · New Brunswick, New Jersey
  • Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) · Greenville, South Carolina
  • Inova Schar Cancer Institute ( Site 0051) · Fairfax, Virginia

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06686394 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior her2-targeted tyrosine kinase inhibitor disqualifies patients from enrollment.

Does this trial require ERBB2?

Yes, ERBB2 overexpression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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