Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
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, Trastuzumab, Trastuzumab Biosimilar, Pertuzumab.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Breast Cancer. 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, Canada, Israel, Japan, South Korea +1
- 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
HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer
Overview
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment
Detailed description
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
Interventions
- Biological Patritumab deruxtecan
Patritumab deruxtecan administered via IV infusion - Biological Trastuzumab
Trastuzumab administered via IV infusion - Biological Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion - Biological Pertuzumab
Pertuzumab administered via IV infusion - Biological Tucatinib
Tucatinib administered as oral tablets
Primary outcome measures
- Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [Time frame: Up to 21 days]
- Number of Participants with One or More Adverse Events (AEs) [Time frame: Up to approximately 13 months]
- Number of Participants who Discontinue Study Intervention Due to an AE [Time frame: Up to approximately 12 months]
Secondary outcome measures (9)
- Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC) [Time frame: At designated time points (up to ~13 months)]
- Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC [Time frame: At designated time points (up to ~13 months)]
- Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC [Time frame: At designated time points (up to ~13 months)]
- Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA) [Time frame: At designated time points (up to ~13 months)]
- Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA [Time frame: At designated time points (up to ~13 months)]
- Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA [Time frame: At designated time points (up to ~13 months)]
- Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload [Time frame: At designated time points (up to ~13 months)]
- Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload [Time frame: At designated time points (up to ~13 months)]
- Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload [Time frame: At designated time points (up to ~13 months)]
Eligibility criteria
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
- Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
Arm 1:
- Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
- Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment
Arm 2:
-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
Arm 3:
-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
- Uncontrolled or significant cardiovascular disease
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
- Has clinically severe respiratory compromise
- Has any history of or evidence of any current leptomeningeal disease
- Has clinically significant corneal disease
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
- HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Evidence of spinal cord compression or brain metastases
- Has an active infection requiring systemic therapy
- Concurrent active HBV and HCV infection
- Has had major surgical procedure (excluding placement of vascular access) less than 28 days
Arm 3 ONLY
\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- University of Colorado Anschutz Medical Campus ( Site 0057) — Aurora
- Dana-Farber Cancer Institute ( Site 0050) — Boston
- Rutgers Cancer Institute of New Jersey ( Site 0052) — New Brunswick
- Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) — Greenville
- Inova Schar Cancer Institute ( Site 0051) — Fairfax
Canada · 4 centers
- Kingston General Hospital ( Site 0061) — Kingston
- Princess Margaret Cancer Centre ( Site 0001) — Toronto
- Centre Hospitalier de l'Université de Montréal ( Site 0004) — Montreal
- Jewish General Hospital ( Site 0003) — Montreal
Israel · 3 centers
- Rambam Health Care Campus ( Site 0011) — Haifa
- Rabin Medical Center ( Site 0012) — Petah Tikva
- Sheba Medical Center ( Site 0010) — Ramat Gan
United Kingdom · 3 centers
- University College London Hospital ( Site 0041) — London
- The Beatson West of Scotland Cancer Centre ( Site 0043) — Glasgow
- St Bartholomew s Hospital ( Site 0040) — London
South Korea · 2 centers
- Seoul National University Hospital ( Site 0030) — Seoul
- Asan Medical Center ( Site 0031) — Seoul
Japan · 1 center
- Nagoya City University Hospital ( Site 0020) — Nagoya
Identifiers
NCT: NCT06686394 · 1022-009 · MK-1022-009 · jRCT2041250022