Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)
Public ClinicalTrials.gov record NCT05159778. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With Metastatic Breast Cancer (mBCA) Who Have Progressed Through Prior Hormonal Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this Phase 2 Simon 2-Stage study is to determinate the Overall Response Rate (ORR) per RECIST v1.1 following treatment with Imprime PGG + pembrolizumab in patients with ER/PR+/ HER2(-) metastatic breast cancer who have progressed through prior hormone therapy with at least one CDK4/6 inhibitor, and a maximum of 2 subsequent chemotherapy treatment. Patients will be screened for baseline anti-β glucan antibody level (ABA; measured in peripheral blood). Those patients with an ABA greater than or equal to 20 mcg/ml and meeting all other I/E criteria, will be enrolled. The study will enroll 47 patients with 23 patients enrolled into Stage 1. If 4 or more patients in Stage 1 have an objective response after 12 weeks of treatment, the study will proceed into Stage 2. A total of 24 patients will be enrolled in Stage 2 for a total combined population of 47. Overall, objective responses must be observed in 10 patients for the study to be declared a success.
Study identification
- NCT ID
- NCT05159778
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 26 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 8, 2021
- Primary completion
- Mar 21, 2023
- Completion
- Apr 11, 2023
- Last update posted
- Jun 21, 2023
2021 – 2023
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 10032 | — |
| The University of Arizona Cancer Center | Tucson | Arizona | 85719 | — |
| University of Colorado at Denver | Denver | Colorado | 80045 | — |
| University of Miami and Clinics -Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Mt. Sinai (Miami) | Miami Beach | Florida | 33140 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Louisiana State University Health Sciences Center - New Orleans | New Orleans | Louisiana | 70112 | — |
| HealthPartners Cancer Research Center | Saint Louis Park | Minnesota | 55426 | — |
| St. Luke's Cancer Institute | Kansas City | Missouri | 64111 | — |
| St. Vincent - Frontier Cancer Center | Billings | Montana | 59102 | — |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Columba University Medical Center | New York | New York | 10032 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| Thomas Jefferson University- Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | — |
| Baptist Clinical Research Institute | Memphis | Tennessee | 38120 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05159778, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05159778 live on ClinicalTrials.gov.