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Clinical Trials in Brazil / NCT07060807
Recruiting Phase 3

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

NCT07060807 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 3
Started
2025-07-21
Last updated
2026-09-28

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Patritumab deruxtecan →Paclitaxel →Nab-paclitaxel →Capecitabine →Pegylated liposomal doxorubicin →Trastuzumab deruxtecan →Rescue Medication

Patritumab deruxtecan: Administered via intravenous (IV) infusion

Paclitaxel: Administered via IV infusion

Nab-paclitaxel: Administered via IV infusion

Capecitabine: Administered via oral tablets

Pegylated liposomal doxorubicin: Administered via IV infusion

Trastuzumab deruxtecan: Administered via IV infusion

Rescue Medication: Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications include: 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (200)

FacilityCityRegionStatus
Southern Cancer Center (SCC) ( Site 8000) Daphne Alabama Recruiting
The University of Arizona Cancer Center - North Campus ( Site 0055) Tucson Arizona Recruiting
Los Angeles Hematology Oncology Medical Group ( Site 0026) Los Angeles California Recruiting
Hoag Memorial Hospital Presbyterian ( Site 0025) Newport Beach California Recruiting
St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) Grand Junction Colorado Recruiting
Medical Oncology Hematology Consultants (MOHC) ( Site 8002) Newark Delaware Recruiting
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024) Altamonte Springs Florida Recruiting
Comprehensive Hematology Oncology ( Site 0060) St. Petersburg Florida Recruiting
Baptist Health Lexington ( Site 0050) Lexington Kentucky Recruiting
Baptist Health Hamburg ( Site 0071) Lexington Kentucky Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) Hackensack New Jersey Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick New Jersey Recruiting
Presbyterian Kaseman Hospital ( Site 0072) Albuquerque New Mexico Recruiting
University of New Mexico Comprehensive Cancer Center ( Site 0047) Albuquerque New Mexico Recruiting
Presbyterian Rust Jorgensen Cancer ( Site 0073) Rio Rancho New Mexico Recruiting
Queens Hospital Cancer Center ( Site 0011) Jamaica New York Recruiting
Optum Medical Care, PC ( Site 0009) Westbury New York Recruiting
Novant Health Cancer Institute ( Site 0019) Charlotte North Carolina Recruiting
Novant Health Oncology Specialists ( Site 0074) Winston-Salem North Carolina Recruiting
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020) Cincinnati Ohio Recruiting
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058) Pittsburgh Pennsylvania Recruiting
Cancer Care Associates Of York ( Site 0063) York Pennsylvania Recruiting
SCRI Oncology Partners ( Site 7000) Nashville Tennessee Recruiting
Tennessee Oncology ( Site 0068) Nashville Tennessee Recruiting
Texas Oncology - DFW ( Site 8003) Dallas Texas Recruiting
JPS Health Network ( Site 0067) Fort Worth Texas Recruiting
Texas Oncology - Gulf Coast ( Site 8006) Houston Texas Recruiting
Oncology Consultants P.A. ( Site 0061) Houston Texas Recruiting
Texas Oncology - Central/South Texas ( Site 8005) McAllen Texas Recruiting
Mays Cancer Center ( Site 0049) San Antonio Texas Recruiting
Virginia Oncology Associates (VOA) ( Site 8001) Norfolk Virginia Recruiting
Shenandoah Oncology ( Site 8004) Winchester Virginia Recruiting
Northwest Medical Specialties, PLLC ( Site 0062) Tacoma Washington Recruiting
Circuit Clinical/SSM Health Dean Medical Group ( Site 0039) Madison Wisconsin Recruiting
Hospital Aleman ( Site 0200) Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) Mar del Plata Buenos Aires Recruiting
Fundación Respirar ( Site 0201) Buenos Aires Buenos Aires F.D. Recruiting
Centro Privado de RMI Rio Cuarto ( Site 0207) Río Cuarto Córdoba Province Recruiting
Instituto de Oncología de Rosario ( Site 0208) Rosario Santa Fe Province Recruiting
Instituto Alexander Fleming ( Site 0202) CABA Argentina Recruiting

+ 160 more sites — see the full list on the official registry below.

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile →

More Merck Sharp & Dohme LLC trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060807 on ClinicalTrials.gov ↗ ← All trials in Brazil