Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT07060807

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Patritumab deruxtecan (biological), Paclitaxel (drug), Nab-paclitaxel (drug), Capecitabine (drug)
How long the study runs
Study runs about 96 months (dates as stated)
About the drug or intervention
Patritumab deruxtecan — biological: Administered via intravenous (IV) infusion · Paclitaxel — drug: Administered via IV infusion · Nab-paclitaxel — drug: Administered via IV infusion · Capecitabine — drug: Administered via oral tablets · Pegylated liposomal doxorubicin — drug: Administered via IV infusion · Trastuzumab deruxtecan — biological: Administered via IV infusion · Rescue Medication — drug: Participants receive rescue medications according to each approved drug's product label.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2025-07-21
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast neoplasms
  • • Phase3 - 1,000 participants
  • • Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast neoplasms

Where?

  • • London - University College London Hospital ( Site 2206)
  • • London - St Bartholomew s Hospital ( Site 2200)
  • • Leicester - Leicester Royal Infirmary ( Site 2205)
  • • Manchester - The Christie NHS Foundation Trust ( Site 2208)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Breast Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2receptor positive

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET)...
  • ✓Has cancer that can be measured on scans 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 activity scale performance status of 0 or 1 assessed within 7 days before randomization

Who cannot take part

  • ✗The main exclusion criteria include but are not limited to the following:
  • ✗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...
  • ✗Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ...
See the full criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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 time of diagnosis of locally advanced unresectable or metastatic breast cancer. A new biopsy obtained after progression of the most recent line of therapy is preferred * 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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) interstitial lung disease (ILD) or pneumonitis irrespective of steroid use, or has current ILD or suspected ILD, or ILD 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

Where Is This Study? (4 UK sites)

University College London Hospital ( Site 2206)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034472930

St Bartholomew s Hospital ( Site 2200)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442073777000

Leicester Royal Infirmary ( Site 2205)

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44116 258 6295

The Christie NHS Foundation Trust ( Site 2208)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441614463000

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10