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Clinical Study of Patritumab Deruxtecan for Breast Cancer

This study is looking for new ways to treat breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), and is either locally advanced (meaning it has spread nearby and can't be removed by surgery) or metastatic (meaning it has spread to other parts of the body). Researchers are testing a drug called Patritumab deruxtecan. They are comparing it to other common treatments like Paclitaxel, Nab-paclitaxel, Capecitabine, and Liposomal doxorubicin. To join, you must be at least 18 years old and have this specific type of breast cancer. The study will measure how long people live without their cancer growing (Progression Free Survival) for up to 45 months, and overall survival for up to 85 months. The current recruitment status is unclear, and the study plans to enroll 1000 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 1000 participants, but the phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression Free Survival for up to 45 months and Overall Survival for up to 85 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07060807

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~1,000 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Patritumab deruxtecanPaclitaxelNab-paclitaxelCapecitabineLiposomal doxorubicinTrastuzumab deruxtecan

At a glance

Recruiting sites
197 of 199 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Up to approximately 45 months
+1 more outcome measured

Conditions

Breast Neoplasms

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Where it's being run

199 sites across 114 states
Turkey (Türkiye)11
Japan8
Texas6
Taiwan6
Region M. de Santiago5
Hong Kong4
Israel4
Italy4

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent
Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)
Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:
Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or
Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization

Exclusion

Has breast cancer amenable to treatment with curative intent
Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
Has any of the following: a pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has ≥Grade 2 peripheral neuropathy.
Has clinically significant corneal disease
Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening
Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients

What this trial measures

  • Progression Free Survival (PFS)Up to approximately 45 months

    PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by blinded independent central review (BICR). Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

  • Overall Survival (OS)Up to approximately 85 months

    OS is the length of time from when the participant starts treatment until death from any cause.