Recruiting
Phase 3

Patritumab Deruxtecan

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07060807

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patritumab deruxtecan

Paclitaxel

Nab-paclitaxel

Capecitabine

Liposomal doxorubicin

Study Details

Brief summary:

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.

Conditions

Breast Neoplasms

Study ID

NCT07060807

Start date

Jul 21, 2025

Status verified date

Aug, 2026

Completion date

Jul 14, 2033

Anticipated

Primary completion date

Jul 14, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 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) 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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patritumab Deruxtecan

Participants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.

active comparator: Treatment of Physician's Choice

Participants receive treatment of physician's choice (TPC) for up to 13 months. The TPC may be any of the following options: Paclitaxel (80 mg/m\^2) on Days 1, 8, 15, and 22 of each 4-week cycle; Paclitaxel (90 mg/m\^2) on Days 1, 8, and 15 of each 4-week cycle; Nab-paclitaxel (100 mg/m\^2) on Days 1, 8, and 15 of each 4-week cycle; Capecitabine (1000 mg/m\^2) bid on Days 1 to 14 of each 3-week cycle; Liposomal doxorubicin (50 mg/m\^2) on Day 1 of each 4-week cycle; or trastuzumab deruxtecan (T-DXd) (5.4 mg/kg) Q3W.

Interventions

Patritumab deruxtecan

Administered via intravenous (IV) infusion

Paclitaxel

Administered via IV infusion

Nab-paclitaxel

Administered via IV infusion

Capecitabine

Administered via oral tablets

Liposomal doxorubicin

Administered via IV infusion

Trastuzumab deruxtecan

Administered via IV infusion

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: Up to approximately 45 months ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 85 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Southern Cancer Center (SCC) ( Site 8000)

Recruiting

Daphne, Alabama, United States, 36526

Contacts

Study Coordinator

251-607-5283

The University of Arizona Cancer Center - North Campus ( Site 0055)

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Study Coordinator

520-626-0191

Los Angeles Hematology Oncology Medical Group ( Site 0026)

Recruiting

Los Angeles, California, United States, 90017

Contacts

Study Coordinator

626-627-6666

Hoag Memorial Hospital Presbyterian ( Site 0025)

Recruiting

Newport Beach, California, United States, 92663

Contacts

Study Coordinator

949-764-5501

St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021)

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Study Coordinator

970-298-7638

Medical Oncology Hematology Consultants (MOHC) ( Site 8002)

Recruiting

Newark, Delaware, United States, 19713

Contacts

Study Coordinator

302-366-1200

AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024)

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Study Coordinator

407-834-5151

Comprehensive Hematology Oncology ( Site 0060)

Recruiting

St. Petersburg, Florida, United States, 33709

Contacts

Study Coordinator

727-344-6569

Baptist Health Lexington ( Site 0050)

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Study Coordinator

859-509-3044

Baptist Health Hamburg ( Site 0071)

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Study Coordinator

859-639-7827

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5900

Rutgers Cancer Institute of New Jersey ( Site 0033)

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Study Coordinator

732-235-2465

Presbyterian Kaseman Hospital ( Site 0072)

Recruiting

Albuquerque, New Mexico, United States, 87110

Contacts

Study Coordinator

505-925-0405

University of New Mexico Comprehensive Cancer Center ( Site 0047)

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Study Coordinator

505-272-4946

Presbyterian Rust Jorgensen Cancer ( Site 0073)

Recruiting

Rio Rancho, New Mexico, United States, 87124

Contacts

Study Coordinator

505-253-7878

Queens Hospital Cancer Center ( Site 0011)

Recruiting

Jamaica, New York, United States, 11432

Contacts

Study Coordinator

718-883-4133

Optum Medical Care, PC ( Site 0009)

Recruiting

Westbury, New York, United States, 11590

Contacts

Study Coordinator

516-488-2918

Novant Health Cancer Institute ( Site 0019)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

980-302-6500

Novant Health Oncology Specialists ( Site 0074)

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Study Coordinator

336-277-8800

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020)

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Study Coordinator

513-865-9460

University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058)

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Study Coordinator

412-641-6500

Cancer Care Associates Of York ( Site 0063)

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Study Coordinator

717-741-9229

SCRI Oncology Partners ( Site 7000)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7274

Tennessee Oncology ( Site 0068)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-320-5090

Texas Oncology - DFW ( Site 8003)

Recruiting

Dallas, Texas, United States, 75246

Contacts

Study Coordinator

214-370-1794

JPS Health Network ( Site 0067)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-702-8049

Texas Oncology - Gulf Coast ( Site 8006)

Recruiting

Houston, Texas, United States, 77024

Contacts

Study Coordinator

713-467-1722

Oncology Consultants P.A. ( Site 0061)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-516-4968

Texas Oncology - Central/South Texas ( Site 8005)

Recruiting

McAllen, Texas, United States, 78503

Contacts

Study Coordinator

956-687-5150

Mays Cancer Center ( Site 0049)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-450-3838

Virginia Oncology Associates (VOA) ( Site 8001)

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Study Coordinator

757-368-5033

Shenandoah Oncology ( Site 8004)

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Study Coordinator

540-662-1108

Northwest Medical Specialties, PLLC ( Site 0062)

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Study Coordinator

253-841-4296

Circuit Clinical/SSM Health Dean Medical Group ( Site 0039)

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Study Coordinator

608-355-2033

The Moncton Hospital ( Site 0101)

Recruiting

Moncton, New Brunswick, Canada, E1C 6Z8

Contacts

Study Coordinator

5068575756

Sunnybrook Research Institute ( Site 0105)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

416-480-5248

Princess Margaret Cancer Center ( Site 0116)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-4501

Centre Hospitalier de l'Université de Montréal ( Site 0113)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Study Coordinator

5148908000

Saskatoon Cancer Centre ( Site 0106)

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Study Coordinator

306-655-2662

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.