Phase 3: testing Patritumab deruxtecan for Breast Neoplasms

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Patritumab deruxtecan, Paclitaxel, or Nab-paclitaxel. The registry lists allocation as randomized. 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.

They plan to enroll about 1,000 people at 206 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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).

Interventions: Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel, Capecitabine, Pegylated liposomal doxorubicin, Trastuzumab deruxtecan, Rescue Medication

Primary outcome (registry wording): Progression Free Survival (PFS)

Who it is for (from inclusion criteria)

• Ages 18 Years to any
• The main who can join include but are not limited to the following:
• 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