An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
New Breast Cancer Trial Tests Promising Therapies Against Standard Care
Plain English Summary
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Breast Neoplasms. This trial is testing a new drug called sacituzumab tirumotecan, both alone and with another drug (pembrolizumab), against the treatment chosen by the patient's doctor. It is for individuals with a specific type of advanced or metastatic breast cancer that is HR+/HER2- and has spread. Participants will receive one of the study treatments, which are given through IV infusion or as a pill, and will have regular check-ups and tests. Alternative treatments include chemotherapy or other therapies chosen by the physician. The trial aims to enroll 1200 participants.
Official Summary
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have HR+/HER2- breast cancer that cannot be removed by surgery and has spread, and if you have had progression on at least one prior endocrine therapy (possibly with a CDK4/6 inhibitor). You must be able to receive chemotherapy and have a good general health status (ECOG 0-1). You cannot join if your cancer can be cured with surgery, if you had a recurrence within 6 months of finishing chemotherapy, or if you have rapidly progressing, life-threatening symptoms from your cancer. Certain autoimmune conditions, lung issues, or active infections may also prevent participation. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if the new treatments can help patients live longer without their cancer getting worse, which means the cancer is controlled for a longer period. The specific primary outcome measures are: Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) (Up to ~38 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a significant need for more effective treatments for advanced HR+/HER2- breast cancer, aiming to improve outcomes for patients who have progressed on existing therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Neoplasms, where improved treatment options are needed.
Investor Insight
This trial targets a large patient population with advanced breast cancer, and success could position sacituzumab tirumotecan and pembrolizumab as new standards of care, representing a significant mar Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1200 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for your specific situation and what the potential benefits and risks are. Be prepared for regular visits for treatment, monitoring, and tests, which may include blood work, scans, and answering quality of life questionnaires. Understand that you will be randomly assigned to one of the treatment groups, and your doctor will choose the comparison treatment. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 1,200 participants
Interventions
- DRUG: Sacituzumab tirumotecan — IV infusion
- BIOLOGICAL: Pembrolizumab — IV infusion
- DRUG: Paclitaxel — IV infusion
- DRUG: Nab-paclitaxel — IV infusion
- DRUG: Capecitabine — oral tablet
Primary Outcomes
- Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) (Up to ~38 months)
Secondary Outcomes
- Overall Survival (OS) (Up to ~77 months)
- Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan) (Up to ~57 months)
- Objective Response Rate (ORR) (Up to ~57 months)
- Duration of Response (DOR) (Up to ~57 months)
- Change 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) (Baseline and up to ~77 months)
Full Eligibility Criteria
Inclusion 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 Exclusion 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
Trial Locations
- Ironwood Cancer & Research Centers ( Site 0066), Chandler, Arizona, United States
- Banner MD Anderson Cancer Center-Oncology ( Site 0004), Gilbert, Arizona, United States
- Providence Medical Foundation-Oncology ( Site 0020), Fullerton, California, United States
- Moores Cancer Center ( Site 0059), La Jolla, California, United States
- Cancer and Blood Specialty Clinic ( Site 0001), Los Alamitos, California, United States
- University of Colorado Anschutz Medical Campus ( Site 0061), Aurora, Colorado, United States
- UCHealth Cherry Creek Medical Center ( Site 0094), Denver, Colorado, United States
- University of Colorado Health - Highlands Ranch Hospital ( Site 0095), Highlands Ranch, Colorado, United States
- Yale Cancer Center ( Site 0060), New Haven, Connecticut, United States
- Stamford Hospital ( Site 0049), Stamford, Connecticut, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06312176?
NCT06312176 is a Phase 3 INTERVENTIONAL study titled "A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 1200 participants.
What conditions does NCT06312176 study?
This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.
What treatments are being tested in NCT06312176?
The interventions being studied include: Sacituzumab tirumotecan (DRUG), Pembrolizumab (BIOLOGICAL), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Capecitabine (DRUG). IV infusion
What does Phase 3 mean for NCT06312176?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06312176?
This trial is currently "Recruiting." It started on 2024-04-14. The estimated completion date is 2031-04-12.
Who is sponsoring NCT06312176?
NCT06312176 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06312176?
The trial aims to enroll 1200 participants. The trial is currently recruiting and accepting new participants.
How is NCT06312176 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06312176?
The primary outcome measures are: Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) (Up to ~38 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06312176 being conducted?
This trial is being conducted at 20 sites, including Chandler, Arizona; Gilbert, Arizona; Fullerton, California; La Jolla, California and 16 more sites (United States).
Where can I find official information about NCT06312176?
The official record for NCT06312176 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06312176. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06312176 testing in simple terms?
This trial is testing a new drug called sacituzumab tirumotecan, both alone and with another drug (pembrolizumab), against the treatment chosen by the patient's doctor. It is for individuals with a specific type of advanced or metastatic breast cancer that is HR+/HER2- and has spread.
Why is this trial significant?
This trial addresses a significant need for more effective treatments for advanced HR+/HER2- breast cancer, aiming to improve outcomes for patients who have progressed on existing therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06312176?
Common side effects may include low blood cell counts, nausea, diarrhea, fatigue, and hair loss. More serious risks can include lung problems, high blood sugar, and severe allergic reactions. Pembrolizumab can cause the immune system to attack healthy organs, leading to inflammation in various parts of the body. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06312176?
Ask your doctor if this trial is a good fit for your specific situation and what the potential benefits and risks are. Be prepared for regular visits for treatment, monitoring, and tests, which may include blood work, scans, and answering quality of life questionnaires. Understand that you will be randomly assigned to one of the treatment groups, and your doctor will choose the comparison treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06312176 signal from an investment perspective?
This trial targets a large patient population with advanced breast cancer, and success could position sacituzumab tirumotecan and pembrolizumab as new standards of care, representing a significant mar This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive one of the study treatments, which are given through IV infusion or as a pill, and will have regular check-ups and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.