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A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer

NCT07701941 · Daiichi Sankyo
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Official title
A Phase 1b/2, Multicenter, Open-label, Dose Regimen Determination and Dose Expansion Trial to Evaluate the Safety, Tolerability, Anti-tumor Activity, and an Optimal Dose Regimen of Patritumab Deruxtecan (HER3-DXd) With Trastuzumab Deruxtecan (T-DXd) in Participants With Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer (HERTHENA-Breast02)
About this study
The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow, unresectable, or metastatic breast cancer.
Eligibility criteria
Key Inclusion Criteria: 1. Pathologically documented breast cancer that meets the following: 1. Unresectable or metastatic. 2. HR+ based on testing performed locally. HR+ (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive \[ER or PgR greater than equal to (≥)1 percent (%)\] per American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] 2020 guidelines) in the unresectable or metastatic setting. 3. Assessed as HER2-low (defined as Immunohistochemistry (IHC)2+/In-situ hybridization (ISH)- or IHC1+) or HER2-ultralow (defined as IHC 0 with any membrane staining in greater than (\>) 0 and lesser than equal to (≤)10% of the cancer cells) locally for Part 1 and centrally for Part 2. The HER2 result must be from a tumor sample obtained in the unresectable or metastatic setting. * For Dose Regimen Determination (Part 1), HER2 status used for eligibility assessment must be determined locally (according to applicable regulations) using the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc.). Additional HER2 testing will be performed locally and according to applicable regulations using the prescribed test during Screening only if prior results obtained with this test are not available for eligibility assessment. * For Dose Expansion (Part 2), HER2 testing will be performed prospectively at a central laboratory using the pretreatment tumor tissue sample. 2. Provides a pretreatment tumor tissue sample that meets one of the following collection requirements: 1. Tissue biopsy collected from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the Tissue Screening informed consent form (ICF) (ARCHIVAL PRETREATMENT sample). OR 2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of the Tissue Screening ICF (FRESH PRETREATMENT sample). 3. Documented radiologic disease progression as per investigator assessment per RECIST v1.1 criteria (during or after most recent treatment). 4. Documented refractoriness to endocrine therapy, defined as disease progression on one or more line of endocrine therapy in the unresectable or metastatic setting and determined by the investigator that participant would no longer benefit from further treatment with endocrine therapy. 5. Prior treatment with a Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting. Subsequent endocrine therapies administered after progression on CDK4/6 inhibitor are allowed. 6. Participants with genomic alterations/mutations (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA), phosphatase and tensin homolog (PTEN), AKT, or Breast Cancer gene (BRCA)1/2) who are eligible for approved targeted therapies in combination with endocrine therapy or as monotherapy (according to local label and availability) must have received the corresponding therapy prior to enrollment, unless contraindicated or not accessible in their country/region. 7. No prior chemotherapy for unresectable or metastatic breast cancer. Participants who have received chemotherapy in the neoadjuvant or adjuvant setting are eligible. 8. ECOG performance status 0 or 1 at the time of Screening. 9. Has ≥1 measurable lesion on CT or MRI per RECIST v1.1 by investigator assessment. 10. Has adequate bone marrow reserve and organ function based on local laboratory data within 7 days prior to the first dose as specified in the protocol. Key Exclusion Criteria: 1. Prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate (ADC) that consists of a topoisomerase I inhibitor (e.g., T-DXd) or any other topoisomerase I inhibitor therapy. 2. Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as CPFE, and any radiographic features consistent with ILA, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. 3. Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the trial. 4. Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive or treated brain metastases who are asymptomatic (i.e., without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the trial but must have a stable neurologic status for ≥4 weeks prior to Cycle 1 Day 1. Participants with asymptomatic brain metastases and treated with anticonvulsants as prophylaxis can enroll. 5. Inadequate washout period of prior treatment before randomization: 1. Whole brain radiation therapy less than (\<)28 days. 2. Monoclonal antibodies other than immune checkpoint inhibitors, such as anti-vascular endothelial growth factor (VEGF) (e.g., bevacizumab) and anti-epidermal growth factor receptor (EGFR) (e.g., cetuximab) \< 28 days. 3. Immune checkpoint inhibitor therapy \<21 days. 4. Major surgery (excluding placement of vascular access) \<28 days. 5. Radiotherapy treatment to more than 30% of the bone marrow or wide field radiation or palliative stereotactic radiation to chest \<28 days or palliative stereotactic radiation therapy to other anatomic areas \<14 days. 6. Chloroquine or hydroxychloroquine ≤14 days. 7. Hormonal therapy \<21 days prior to first dose of HER3-DXd. 8. Live or live attenuated virus vaccination \<30 days. 6. Uncontrolled or significant cardiovascular disease, including any of the following: 1. QTcF prolongation interval \>450 milliseconds (ms) (average of triplicate determinations at screening). 2. Left ventricular ejection fraction (LVEF) ≤50%. 3. Resting systolic blood pressure \>160 millimeters of mercury (mmHg) or diastolic blood pressure \>100 mmHg. 4. Myocardial infarction within 6 months. 5. New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure. 6. Uncontrolled angina pectoris within 6 months. 7. Cardiac arrhythmia requiring ongoing antiarrhythmic treatment. 8. Diagnosed or suspected long QT syndrome or known family history of long QT syndrome. 9. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes. 10. Bradycardia of \<50 beats per minute (bpm) unless the participant has a pacemaker. 11. History of second- or third-degree heart block. Participants with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers. 12. Coronary/peripheral artery bypass graft within 6 months. 13. Complete left bundle branch block. 7. Has history of other active malignancy within 3 years prior to randomization, except the following: 1. Adequately resected nonmelanoma skin cancer. 2. Adequately treated intraepithelial carcinoma of the cervix. 3. Any other curatively treated in situ disease. 4. Prostate carcinoma with a prostate-specific antigen value \<0.2 nanograms per milliliter (ng/mL). 8. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) Grade ≤1 or baseline. 9. Any known contraindication to treatment, including hypersensitivity to either the drug substances or inactive ingredients in the drug products. Note: Other protocol specified inclusion/exclusion criteria may apply.
Study design
Enrollment target: 220 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-09-17
Estimated completion: 2032-05-01
Last updated: 2026-10-01
Interventions
Drug: Patritumab deruxtecanDrug: Trastuzumab deruxtecan
Primary outcomes
  • • Part 1: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) (Up to approximately 4.5 years)
  • • Part 2: Objective Response Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v.1.1) as Assessed by the Investigator (Up to approximately 4.5 years)
Sponsor
Daiichi Sankyo · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactDaiichi Sankyo Contact for Clinical Trial Information · contact · CTRinfo_us@daiichisankyo.com · 9089926400
All locations (72)
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer InstituteNot Yet Recruiting
Los Angeles, California, United States
Stanford Medicine Cancer CenterNot Yet Recruiting
Stanford, California, United States
University of Colorado Denver - School of Medicine - Anschutz Medical CampusNot Yet Recruiting
Aurora, Colorado, United States
Yale University School of Medicine - Yale Cancer CenterNot Yet Recruiting
New Haven, Connecticut, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteNot Yet Recruiting
Boston, Massachusetts, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Compass Oncology - Rose Quarter Cancer CenterNot Yet Recruiting
Portland, Oregon, United States
The West Cancer CenterNot Yet Recruiting
Memphis, Tennessee, United States
SCRI Oncology PartnersNot Yet Recruiting
Nashville, Tennessee, United States
University of Texas SouthwesternNot Yet Recruiting
Dallas, Texas, United States
Virginia Oncology AssociatesNot Yet Recruiting
Norfolk, Virginia, United States
Cliniques Universitaires Saint-LucNot Yet Recruiting
Brussels, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
Centre Francois BaclesseNot Yet Recruiting
Caen, France
Centre Georges Francois LeclercNot Yet Recruiting
Dijon, France
Centre Oscar LambretNot Yet Recruiting
Lille, France
Centre Leon BerardNot Yet Recruiting
Lyon, France
Institut Paoli-CalmettesNot Yet Recruiting
Marseille, France
ICM - Institut Regional du Cancer de MontpellierNot Yet Recruiting
Montpellier, France
Centre Antoine-LacassagneNot Yet Recruiting
Nice, France
CHU de NimesNot Yet Recruiting
Nîmes, France
Institut CurieNot Yet Recruiting
Paris, France
Centre Eugene MarquisNot Yet Recruiting
Rennes, France
Institut de Cancerologie de l'Ouest - site St-HerblainNot Yet Recruiting
Saint-Herblain, France
Oncopole Claudius RegaudNot Yet Recruiting
Toulouse, France
Institut de Cancerologie de Lorraine - Alexis VautrinNot Yet Recruiting
Vandœuvre-lès-Nancy, France
Institut Gustave RoussyNot Yet Recruiting
Villejuif, France
Centro Riferimento Oncologico - AvianoNot Yet Recruiting
Aviano, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.Not Yet Recruiting
Meldola, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriNot Yet Recruiting
Milan, Italy
Istituto Europeo di OncologiaNot Yet Recruiting
Milan, Italy
Fondazione IRCCS San Gerardo dei TintoriNot Yet Recruiting
Monza, Italy
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale BusoneraNot Yet Recruiting
Padova, Italy
Azienda Ospedaliero Universitaria PisanaNot Yet Recruiting
Pisa, Italy
National Cancer Center Hospital EastNot Yet Recruiting
Kashiwa, Chiba, Japan
Tokai University HospitalRecruiting
Isehara, Kanagawa, Japan
Kanagawa Cancer CenterNot Yet Recruiting
Yokohama, Kanagawa, Japan
Kansai Medical University HospitalNot Yet Recruiting
Hirakata, Osaka, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCRRecruiting
Koto-ku, Tokyo, Japan
Showa Medical University HospitalNot Yet Recruiting
Shinagawa-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer CenterNot Yet Recruiting
Fukuoka, Japan
Fukushima Medical University HospitalRecruiting
Fukushima, Japan
Osaka International Cancer InstituteNot Yet Recruiting
Osaka, Japan
Seoul National University Bundang HospitalNot Yet Recruiting
Seongnam-si, South Korea
Seoul National University HospitalNot Yet Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemNot Yet Recruiting
Seoul, South Korea
Asan Medical CenterNot Yet Recruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Institut Catala d'Oncologia - BadalonaNot Yet Recruiting
Badalona, Spain
NEXT Oncology BarcelonaNot Yet Recruiting
Barcelona, Spain
Hospital Universitari Quiron Dexeus BarcelonaNot Yet Recruiting
Barcelona, Spain
Hospital Universitario Vall d'HebronNot Yet Recruiting
Barcelona, Spain
Hospital Clinic BarcelonaNot Yet Recruiting
Barcelona, Spain
Hospital Universitario San CecilioNot Yet Recruiting
Granada, Spain
Hospital Beata Maria AnaNot Yet Recruiting
Madrid, Spain
Clinica Universidad de Navarra - MadridNot Yet Recruiting
Madrid, Spain
Hospital Universitario Ramon y CajalNot Yet Recruiting
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCCNot Yet Recruiting
Madrid, Spain
Hospital Regional Universitario de MalagaNot Yet Recruiting
Málaga, Spain
Hospital Universitario Virgen de la VictoriaNot Yet Recruiting
Málaga, Spain
Clinica Universidad de Navarra - PamplonaNot Yet Recruiting
Pamplona, Spain
NEXT Oncology MadridNot Yet Recruiting
Pozuelo de Alarcón, Spain
Hospital Universitario de CanariasNot Yet Recruiting
Santa Cruz de Tenerife, Spain
Hospital Clinico Universitario de SantiagoNot Yet Recruiting
Santiago de Compostela, Spain
Hospital Universitario Virgen del RocioNot Yet Recruiting
Seville, Spain
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Veterans General HospitalNot Yet Recruiting
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer CenterNot Yet Recruiting
Taipei, Taiwan