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Clinical trial that compares MK-2870 with or without pembrolizumab to chemotherapy in people with breast cancer that cannot be surgically removed.
EU CTIS ID: 2023-504918-29-00
What this study is testing
1. To compare MK-2870 to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants. 2. To compare MK-2870 plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Has unresectable locally advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- 2. 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.
- 3. Is a chemotherapy candidate
- 4. Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- 5. Has adequate organ function
- 6. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
You likely can't join if
- 1. Has breast cancer amenable to treatment with curative intent
- 2. Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- 3. Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- 4. Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- 5. Active autoimmune disease that has required systemic treatment in the past 2 years
- 6. History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
See the full eligibility criteria
- 1. Has unresectable locally advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- 2. 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.
- 3. Is a chemotherapy candidate
- 4. Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- 5. Has adequate organ function
- 6. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- 7. 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
- 8. Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- 1. Has breast cancer amenable to treatment with curative intent
- 2. Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- 3. Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- 4. Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- 5. Active autoimmune disease that has required systemic treatment in the past 2 years
- 6. History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- 7. Has an active infection requiring systemic therapy
The study team makes the final eligibility decision.
Where it's taking place
- Malaysia
- Hong Kong
- United States
- Israel
- Australia
- Mexico
- New Zealand
- Taiwan
- Switzerland
- Colombia
- Korea, Republic of
- India
- Canada
- Singapore
- Japan
- South Africa
- Philippines
- Brazil
- China
- United Kingdom
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malaysia; Hong Kong; United States; Israel; Australia; Mexico and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.