A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests patritumab deruxtecan for breast cancer that grows with hormones (HR+) and has low levels of the HER2 protein (HER2-). It is for people whose cancer cannot be fully removed by surgery or has spread to other parts of the body. Researchers will compare it with chemotherapy or trastuzumab deruxtecan to see if people live longer or go longer without the cancer growing or spreading.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have HR+/HER2- breast cancer that has spread nearby or to other body parts and cannot be treated with the goal of a cure.
- Have a tumor sample from an advanced cancer site that confirms HR+ and HER2- results and can be tested for the HER3 protein.
- Have cancer that grew during your only treatment for advanced cancer: hormone treatment plus a CDK4/6 inhibitor, a drug that slows cancer cell growth. Or, have cancer that returned during this drug combination after surgery or within 24 months after the last CDK4/6 inhibitor dose.
- Have cancer that can be measured on scans.
- If you have HIV, it must be well controlled with HIV medicines.
- Be fully active or able to do light work, as checked within 7 days before study group assignment.
Who can't join
- Your cancer could be treated with the goal of a cure, or more hormone-based treatment is an option. You also cannot join if you have an inherited harmful or likely harmful BRCA gene change and a PARP inhibitor drug is a treatment option.
- Cancer is causing, or may soon cause, organ failure or other life-threatening problems.
- Your oxygen level is below 92% at rest, you need extra oxygen, or you have current, past, or suspected lung scarring or inflammation not caused by infection.
- You have serious, uncontrolled heart or brain blood vessel disease, moderate or worse nerve damage in your hands or feet, or serious disease of the clear front layer of your eye.
- You have had chemotherapy for advanced breast cancer, an anti-HER3 antibody, or a drug called a topoisomerase I inhibitor, including antibody-linked drugs such as trastuzumab deruxtecan.
- You received cancer medicines too recently. Hormone treatment plus a CDK4/6 inhibitor must have stopped at least 2 weeks before study group assignment. Recent radiation outside the brain or spinal cord, or steroids for its side effects, may also prevent you from joining.
- You have an immune system disorder, take ongoing steroids that affect the whole body, or have another cancer that is growing or needed treatment within the past 3 years.
- You have a severe allergy to patritumab deruxtecan or its ingredients, or to all available comparison treatments or their ingredients.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (35)
AL
- Southern Cancer Center (SCC) ( Site 8000) · Daphne, AL 36526Study Coordinator · Study contact · 251-607-5283More trials in Daphne
AZ
- The University of Arizona Cancer Center - North Campus ( Site 0055) · Tucson, AZ 85719Study Coordinator · Study contact · 520-626-0191More trials in Tucson
CA
- Los Angeles Hematology Oncology Medical Group ( Site 0026) · Los Angeles, CA 90017Study Coordinator · Study contact · 626-627-6666More trials in Los Angeles
- Hoag Memorial Hospital Presbyterian ( Site 0025) · Newport Beach, CA 92663Study Coordinator · Study contact · 949-764-5501More trials in Newport Beach
CO
- St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) · Grand Junction, CO 81501Study Coordinator · Study contact · 970-298-7638More trials in Grand Junction
DE
- Medical Oncology Hematology Consultants (MOHC) ( Site 8002) · Newark, DE 19713Study Coordinator · Study contact · 302-366-1200More trials in Newark
FL
- AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024) · Altamonte Springs, FL 32701Study Coordinator · Study contact · 407-834-5151More trials in Altamonte Springs
- Comprehensive Hematology Oncology ( Site 0060) · St. Petersburg, FL 33709Study Coordinator · Study contact · 727-344-6569More trials in St. Petersburg
KY
- Baptist Health Lexington ( Site 0050) · Lexington, KY 40503Study Coordinator · Study contact · 859-509-3044More trials in Lexington
- Baptist Health Hamburg ( Site 0071) · Lexington, KY 40509Study Coordinator · Study contact · 859-639-7827More trials in Lexington
NC
- Novant Health Cancer Institute ( Site 0019) · Charlotte, NC 28204Study Coordinator · Study contact · 980-302-6500More trials in Charlotte
- Novant Health Oncology Specialists ( Site 0074) · Winston-Salem, NC 27103Study Coordinator · Study contact · 336-277-8800More trials in Winston-Salem
NJ
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) · Hackensack, NJ 07601Study Coordinator · Study contact · 551-996-5900More trials in Hackensack
- Rutgers Cancer Institute of New Jersey ( Site 0033) · New Brunswick, NJ 08903Study Coordinator · Study contact · 732-235-2465More trials in New Brunswick
NM
- Presbyterian Kaseman Hospital ( Site 0072) · Albuquerque, NM 87110Study Coordinator · Study contact · 505-925-0405More trials in Albuquerque
- University of New Mexico Comprehensive Cancer Center ( Site 0047) · Albuquerque, NM 87131Study Coordinator · Study contact · 505-272-4946More trials in Albuquerque
- Presbyterian Rust Jorgensen Cancer ( Site 0073) · Rio Rancho, NM 87124Study Coordinator · Study contact · 505-253-7878More trials in Rio Rancho
NV
- Cancer Care Specialists ( Site 9503) · Reno, NV 89511Study Coordinator · Study contact · 775-329-0222x230More trials in Reno
NY
- Queens Hospital Cancer Center ( Site 0011) · Jamaica, NY 11432Study Coordinator · Study contact · 718-883-4133More trials in Jamaica
- Optum Medical Care, PC ( Site 0009) · Westbury, NY 11590Study Coordinator · Study contact · 516-488-2918More trials in Westbury
OH
- TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020) · Cincinnati, OH 45220Study Coordinator · Study contact · 513-865-9460More trials in Cincinnati
PA
- University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058) · Pittsburgh, PA 15213Study Coordinator · Study contact · 412-641-6500More trials in Pittsburgh
- Cancer Care Associates Of York ( Site 0063) · York, PA 17403Study Coordinator · Study contact · 717-741-9229More trials in York
TN
- SCRI Oncology Partners ( Site 7000) · Nashville, TN 37203Study Coordinator · Study contact · 615-329-7274More trials in Nashville
- Tennessee Oncology ( Site 0068) · Nashville, TN 37203Study Coordinator · Study contact · 615-320-5090More trials in Nashville
TX
- Texas Oncology - DFW ( Site 8003) · Dallas, TX 75246Study Coordinator · Study contact · 214-370-1794More trials in Dallas
- JPS Health Network ( Site 0067) · Fort Worth, TX 76104Study Coordinator · Study contact · 817-702-8049More trials in Fort Worth
- Texas Oncology - Gulf Coast ( Site 8006) · Houston, TX 77024Study Coordinator · Study contact · 713-467-1722More trials in Houston
- Oncology Consultants P.A. ( Site 0061) · Houston, TX 77030Study Coordinator · Study contact · 713-516-4968More trials in Houston
- Texas Oncology - Central/South Texas ( Site 8005) · McAllen, TX 78503Study Coordinator · Study contact · 956-687-5150More trials in McAllen
- Mays Cancer Center ( Site 0049) · San Antonio, TX 78229Study Coordinator · Study contact · 210-450-3838More trials in San Antonio
VA
- Virginia Oncology Associates (VOA) ( Site 8001) · Norfolk, VA 23502Study Coordinator · Study contact · 757-368-5033More trials in Norfolk
- Shenandoah Oncology ( Site 8004) · Winchester, VA 22601Study Coordinator · Study contact · 540-662-1108More trials in Winchester
WA
- Northwest Medical Specialties, PLLC ( Site 0062) · Tacoma, WA 98405Study Coordinator · Study contact · 253-841-4296More trials in Tacoma
WI
- Circuit Clinical/SSM Health Dean Medical Group ( Site 0039) · Madison, WI 53715Study Coordinator · Study contact · 608-355-2033More trials in Madison