MK-2870 with or without pembrolizumab in HR+/HER2- metastatic breast cancer

JRCT ID: jRCT2031240476

Registered date:11/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: HR+/HER2 unresectable locally advanced or metastatic breast cancer
• Date of first enrollment: 25/12/2024
• Target sample size: 77
• Countries of recruitment: USA,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Costa Rica,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Peru,Japan,Philippines,Japan,Poland,Japan,Refer to 7-5,Japan
• Study type: Interventional

Intervention(s)

Arm A:MK-2870
Participants receive 4 mg/kg of MK-2870 once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.

Arm B:MK-2870+Pembrolizumab
Participants receive 4 mg/kg of MK-2870 Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to ~2 years).

Arm C:treatment of physician's choice(TPC)
At the physician's discretion, participants receive chemotherapy of 80 mg/m2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m2 of liposomal doxorubicin once Q4W via IV infusion, until progressive disease or discontinuation.

Outcome(s)

• Primary Outcome: -Progression free survival (PFS): The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

Secondary Outcome

-Overall Survival (OS): The time from randomization to death due to any cause.
-Objective Response (OR): Complete response(CR) or partial response(PR).
-Duration of Response (DOR) : For participants who demonstrate confirmed CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
-Change from baseline in European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ)-C30 as follows:
-global health status/Quality of Life(QoL) scores,
-physical functioning score,
-emotional functioning score,
-fatigue score,
-diarrhea score.
-Time to first deterioration (TTD) from baseline to the first onset of a 10-points deterioration as measured by the following score from the EORTC QLQ-C30:
-global health status/QoL scores,
-physical functioning score,
-emotional functioning score,
-fatigue score,
-diarrhea score.
-AEs
-AEs leading to study treatment discontinuation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
-Has 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
-Is a chemotherapy candidate
-Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
-Has adequate organ function
-Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
-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 HBV viral load
-Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclude criteria

-Has breast cancer amenable to treatment with curative intent
-Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
-Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
-Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
-Active autoimmune disease that has required systemic treatment in the past 2 years
-History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
-Has an active infection requiring systemic therapy

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT06312176