Sacituzumab tirumotecan for Hormone receptor-positive (HR+) HER2-negative locally advanced or metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- 1.\tHas unresectable locally advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer\n- 2.\tHas radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor.\n- 3.\tIs a chemotherapy candidate\n- 4.\tHas an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n- 5.\tHas adequate organ function\n- 6.\tHuman immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n- 7.\tParticipants 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 HBV viral load\n- 8.\tParticipants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable"}

Exclusion criteria

• {"criterion_text":"- 1.\tHas breast cancer amenable to treatment with curative intent\n- 2.\tHas experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment\n- 3.\tHas symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications\n- 4.\tHas received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n- 5.\tActive autoimmune disease that has required systemic treatment in the past 2 years\n- 6.\tHistory of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease\n- 7.\tHas an active infection requiring systemic therapy"}

Primary endpoints

• {"endpoint_text":"- Progression-Free Survival (PFS) (MK-2870 versus treatment of physician’s choice [TPC]; MK-2870 + pembrolizumab versus TPC)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by Blind Independent Central Review (BICR)"}

Secondary endpoints

• {"endpoint_text":"- 1.\tOverall Survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2.\tProgression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR"}
• {"endpoint_text":"- 3.\tObjective Response Rate (ORR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by BICR (where specified in objectives)"}
• {"endpoint_text":"- 4.\tDuration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR (where specified in objectives)"}
• {"endpoint_text":"- 5.\tChange from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Measured by EORTC QLQ-C30 questionnaire"}
• {"endpoint_text":"- 6.\tChange from baseline in physical functioning score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Measured by EORTC QLQ-C30 questionnaire"}
• {"endpoint_text":"- 7.\tChange from baseline in emotional functioning score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Measured by EORTC QLQ-C30 questionnaire"}
• {"endpoint_text":"- 8.\tChange from baseline in fatigue score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Measured by EORTC QLQ-C30 questionnaire"}
• {"endpoint_text":"- 9.\tChange from baseline in diarrhea score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Measured by EORTC QLQ-C30 questionnaire"}
• {"endpoint_text":"- 10.\tTime to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to first deterioration measured using EORTC QLQ-C30"}
• {"endpoint_text":"- 11.\tTTD in physical functioning score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to first deterioration measured using EORTC QLQ-C30"}
• {"endpoint_text":"- 12.\tTTD in emotional functioning score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to first deterioration measured using EORTC QLQ-C30"}
• {"endpoint_text":"- 13.\tTTD in fatigue score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to first deterioration measured using EORTC QLQ-C30"}
• {"endpoint_text":"- 14.\tTTD in diarrhea score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to first deterioration measured using EORTC QLQ-C30"}
• {"endpoint_text":"- 15.\tNumber of participants who experience one or more Adverse Events (AEs)","definition_or_measurement_approach":"Safety reporting of AEs per trial safety procedures"}
• {"endpoint_text":"- 16.\tNumber of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":"Reported discontinuations due to AEs"}

Methods

• Patient brochures (country-specific; e.g., patient brochure documents present for multiple countries)
• Posters (recruitment posters present in country-specific recruitment documents)
• Website recruitment content (country-specific recruitment website documents listed)
• Print advertisements (e.g., patient print ad documents in recruitment materials)
• Patient visit guides and study cards (site-facing recruitment materials)

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Icon Clinical Research Limited

Responsibilities

Central Imaging

Name

IQVIA Limited

Responsibilities

Responsibilities indicated (code '4')

Name

Signant Health Global Solutions Limited

Responsibilities

eCOA/eConsent and related services (duties codes '3' and '7' listed)

Third parties

• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company / CRO"}
• {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"ER, PR, HER2 , H&E","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Roche Tissue Diagnostics","duties_or_roles":"unspecified (sponsor duties list includes code '4')","organisation_type":"Industry"}
• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Responsibilities include codes '3' and '7' (as listed in sponsor duties)","organisation_type":"Pharmaceutical company / eCOA provider"}
• {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"TROP2 Assay; additional duties indicated","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company / CRO"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Responsibilities indicated (code '4')","organisation_type":"Pharmaceutical company / CRO"}