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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)
EU CTIS ID: 2025-520582-51-00
What this study is testing
1. To compare patritumab deruxtecan (HER3-DXd) to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants. 2. To compare HER3-DXd to TPC with respect to OS in all participants.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has a diagnosis of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/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 4 and 6 (CDK4/6) inhibitor + endocrine therapy (ET) with one of the following: a. Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as first line (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 b. 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
- Is determined by the investigator to be a candidate for at least 1 treatment of physician’s choice (TPC) option
- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (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
You likely can't join if
- Has breast cancer amenable to treatment with curative intent
- Has ≥Grade 2 peripheral neuropathy
- Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (e.g., 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
See the full eligibility criteria
Who can join
- Has a diagnosis of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/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 4 and 6 (CDK4/6) inhibitor + endocrine therapy (ET) with one of the following: a. Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as first line (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 b. 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
- Is determined by the investigator to be a candidate for at least 1 treatment of physician’s choice (TPC) option
- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (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
What rules you out
- Has breast cancer amenable to treatment with curative intent
- Has ≥Grade 2 peripheral neuropathy
- Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (e.g., 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 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
- Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator. Patients with alterations/mutations in phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3KCA), phosphatase and tensin homolog (PTEN), alpha-serine/threonine kinase (AKT), or estrogen receptor 1 (ESR1) who are deemed suitable for second line (2L) treatment with ET in combination with targeted therapy, where available, are not eligible
- Has a known germline BReast CAncer gene (BRCA) mutation (deleterious or suspected deleterious) where poly adenosine diphosphate-ribose polymerase (PARP) inhibitor(s) is a potential treatment option (i.e., available and not medically contraindicated)
- 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 clinically significant corneal disease
- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Japan
- United Kingdom
- Argentina
- Peru
- Canada
- Australia
- Chile
- Korea, Republic of
- Taiwan
- China
- Brazil
- Colombia
- Mexico
- Turkey
- Vietnam
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Japan; United Kingdom; Argentina; Peru; Canada and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.