A Clinical Study of Patritumab Deruxtecan to Treat Breast... | NCT07060807

NCT07060807

ID	Type	Description
U1111-1317-5490	Registry Identifier	UTN
2025-520582-51-00	Registry Identifier	EU CT
jRCT2031250297	Registry Identifier	Japan Registry of Clinical Trial (jRCT)

Status Module

Name	Class
Daiichi Sankyo	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patritumab Deruxtecan	Experimental	Participants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.	Biological: Patritumab deruxtecan
Treatment of Physician's Choice	Active Comparator	Participants receive treatment of physician's choice (TPC) for up to 13 months. The TPC may be any of the following options: Paclitaxel (80 mg/m^2) on Days 1, 8, 15, and 22 of each 4-week cycle; Paclitaxel (90 mg/m^2) on Days 1, 8, and 15 of each 4-week cycle; Nab-paclitaxel (100 mg/m^2) on Days 1, 8, and 15 of each 4-week cycle; Capecitabine (1000 mg/m^2) bid on Days 1 to 14 of each 3-week cycle; Liposomal doxorubicin (50 mg/m^2) on Day 1 of each 4-week cycle; or trastuzumab deruxtecan (T-DXd) (5.4 mg/kg) Q3W.	Drug: Paclitaxel Drug: Nab-paclitaxel Drug: Capecitabine Drug: Liposomal doxorubicin Biological: Trastuzumab deruxtecan

Name	Type	Description	Arm Group Labels	Other Names
Patritumab deruxtecan	Biological	Administered via intravenous (IV) infusion	Patritumab Deruxtecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by blinded independent central review (BICR). Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.	Up to approximately 45 months
Overall Survival (OS)	OS is the length of time from when the participant starts treatment until death from any cause.	Up to approximately 85 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.	Up to approximately 85 months
Duration of Response (DOR)

Eligibility Module

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

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary Link	View source

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C000710748	patritumab deruxtecan
D017239	Paclitaxel
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel
D000069287	Capecitabine
C506643	liposomal doxorubicin
C000614160	trastuzumab deruxtecan

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides