Clinical Trials in Italy / NCT06312176
Recruiting
Phase 3
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)
NCT06312176 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Breast Neoplasms
Investigational drug(s) / intervention(s)
Sacituzumab tirumotecan →Pembrolizumab →Paclitaxel →Nab-paclitaxel →Capecitabine →Liposomal doxorubicin →
Sacituzumab tirumotecan: IV infusion
Pembrolizumab: IV infusion
Paclitaxel: IV infusion
Nab-paclitaxel: IV infusion
Capecitabine: oral tablet
Liposomal doxorubicin: IV infusion
Study 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.
Eligibility
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
Primary outcome measure(s)
- Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) — Up to ~40 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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. PFS as assessed by blinded independent central review (BICR) will be presented. - PFS (Sacituzumab tirumotecan + pembrolizumab versus TPC) — Up to ~40 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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. PFS as assessed by BICR in participants with programmed cell death ligand 1 (PD-L1) at combined positive score (CPS) ≥1 tumors will be presented.
Trial sites (259)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer & Research Centers ( Site 0066) | Chandler | Arizona | Recruiting |
| Banner MD Anderson Cancer Center-Oncology ( Site 0004) | Gilbert | Arizona | Recruiting |
| Providence Medical Foundation-Oncology ( Site 0020) | Fullerton | California | Recruiting |
| Moores Cancer Center ( Site 0059) | La Jolla | California | Active Not Recruiting |
| Cancer and Blood Specialty Clinic ( Site 0001) | Los Alamitos | California | Active Not Recruiting |
| University of Colorado Anschutz Medical Campus ( Site 0061) | Aurora | Colorado | Recruiting |
| UCHealth Cherry Creek Medical Center ( Site 0094) | Denver | Colorado | Recruiting |
| University of Colorado Health - Highlands Ranch Hospital ( Site 0095) | Highlands Ranch | Colorado | Completed |
| Yale Cancer Center ( Site 0060) | New Haven | Connecticut | Recruiting |
| Stamford Hospital ( Site 0049) | Stamford | Connecticut | Recruiting |
| AdventHealth Altamonte Springs ( Site 0021) | Altamonte Springs | Florida | Recruiting |
| University of Florida College of Medicine ( Site 0063) | Gainesville | Florida | Active Not Recruiting |
| Orlando Health Cancer Institute ( Site 0011) | Orlando | Florida | Recruiting |
| Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) | Thomasville | Georgia | Recruiting |
| Rush University Medical Center ( Site 0079) | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center ( Site 0067) | Chicago | Illinois | Active Not Recruiting |
| Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053) | Edgewood | Kentucky | Recruiting |
| Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042) | Baton Rouge | Louisiana | Recruiting |
| Greenebaum Comprehensive Cancer Center ( Site 0036) | Baltimore | Maryland | Recruiting |
| Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028) | Baltimore | Maryland | Completed |
| Holy Cross Hospital ( Site 0073) | Silver Spring | Maryland | Recruiting |
| Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037) | Boston | Massachusetts | Recruiting |
| Henry Ford Health ( Site 0002) | Detroit | Michigan | Recruiting |
| Saint Luke's Cancer Institute ( Site 0027) | Kansas City | Missouri | Recruiting |
| Washington University School of Medicine ( Site 0076) | St Louis | Missouri | Recruiting |
| NYU Langone Health - Brooklyn ( Site 0089) | Brooklyn | New York | Recruiting |
| NYU Langone Hospital - Long Island ( Site 0090) | Mineola | New York | Recruiting |
| Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068) | New York | New York | Recruiting |
| Hematology Oncology Associates of Rockland ( Site 0054) | Nyack | New York | Recruiting |
| Stony Brook University-Cancer Center ( Site 0034) | Stony Brook | New York | Recruiting |
| Levine Cancer Institute ( Site 0014) | Charlotte | North Carolina | Recruiting |
| Zangmeister Cancer Center ( Site 7000) | Columbus | Ohio | Completed |
| Providence Portland Medical Center ( Site 0044) | Portland | Oregon | Recruiting |
| Providence St. Vincent Medical Center ( Site 0081) | Portland | Oregon | Recruiting |
| Thomas Jefferson University - Clinical Research Institute ( Site 0056) | Philadelphia | Pennsylvania | Recruiting |
| Texas Oncology-Dallas Presbyterian Hospital ( Site 8000) | Dallas | Texas | Recruiting |
| Parkland Health and Hospital System ( Site 0069) | Dallas | Texas | Recruiting |
| UT Southwestern Medical Center ( Site 0050) | Dallas | Texas | Recruiting |
| The Center for Cancer and Blood Disorders ( Site 0041) | Fort Worth | Texas | Recruiting |
| Texas Oncology - San Antonio ( Site 8002) | San Antonio | Texas | Recruiting |
+ 219 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Active, not recruiting
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06312176 on ClinicalTrials.gov ↗ ← All trials in Italy