Recruiting NCT07060807

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

Phase III Interventional Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel, Capecitabine.
Who it may be relevant to: Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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).

Overview

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.

Interventions

Biological Patritumab deruxtecan
Administered via intravenous (IV) infusion
Drug Paclitaxel
Administered via IV infusion
Drug Nab-paclitaxel
Administered via IV infusion
Drug Capecitabine
Administered via oral tablets
Drug Liposomal doxorubicin
Administered via IV infusion
Biological Trastuzumab deruxtecan
Administered via IV infusion

Primary outcome measures

Progression Free Survival (PFS) [Time frame: Up to approximately 45 months]
Overall Survival (OS) [Time frame: Up to approximately 85 months]

Secondary outcome measures (12)

Objective Response Rate (ORR) [Time frame: Up to approximately 85 months]
Duration of Response (DOR) [Time frame: Up to approximately 85 months]
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score [Time frame: Baseline and up to approximately 85 months]
Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score [Time frame: Baseline and up to approximately 85 months]
Change from Baseline in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score [Time frame: Baseline and up to approximately 85 months]
Change from Baseline in the EORTC-QLQ-C30 Pain (Items 9 and 19) Combined Score [Time frame: Baseline and up to approximately 85 months]
Time to First Deterioration (TTD) in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score [Time frame: Baseline and up to approximately 85 months]
TTD in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score [Time frame: Baseline and up to approximately 85 months]
TTD in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score [Time frame: Baseline and up to approximately 85 months]
TTD in the EORTC-QLQ-C30 Pain (Items 9 and 19) Combined Score [Time frame: Baseline and up to approximately 85 months]
Number of Participants Who Experience One or More Adverse Event (AEs) [Time frame: Up to approximately 85 months]
Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 85 months]

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 most recent line of therapy (with certain exceptions)
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) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 34 centers

Southern Cancer Center (SCC) ( Site 8000) — Daphne
The University of Arizona Cancer Center - North Campus ( Site 0055) — Tucson
Los Angeles Hematology Oncology Medical Group ( Site 0026) — Los Angeles
Hoag Memorial Hospital Presbyterian ( Site 0025) — Newport Beach
St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Sit — Grand Junction
Medical Oncology Hematology Consultants (MOHC) ( Site 8002) — Newark
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024) — Altamonte Springs
Comprehensive Hematology Oncology ( Site 0060) — St. Petersburg
… and 26 more centers

China · 23 centers

Anhui Provincial Cancer Hospital ( Site 3140) — Hefei
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3100) — Beijing
Peking University People's Hospital ( Site 3138) — Beijing
The First Affiliated Hospital of Chongqing Medical University ( Site 3101) — Chongqing
Chongqing Three Gorges Central Hospital's ( Site 3128) — Wanzhou
The First Affiliated hospital of Xiamen University ( Site 3120) — Fujian
Sun Yat-Sen University Cancer Center ( Site 3102) — Guangzhou
Jiangmen Central Hospital ( Site 3132) — Jiangmen
… and 15 more centers

Japan · 20 centers