Ignite Creation Date:
2024-05-06 @ 8:00 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02648477
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2016-01-05
Brief Title:
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
MK-3475 Pembrolizumab in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive HR HER2- Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy anastrozole letrozole or exemestane in treating patients with triple-negative or hormone-receptor positive breast cancer that has spread from the primary site place where it started to other places in the body Pembrolizumab is an antibody drug that blocks a molecule called programmed death PD-1 PD-1 is a molecule that shuts down the bodys immune responses and prevents the immune system from attacking the cancer Doxorubicin hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by stopping them from dividing and by causing them to die Anti-estrogen therapy including anastrozole letrozole and exemestane lowers estrogen levels in the body which may help treat cancer that is hormone receptor-positive Giving pembrolizumab together with standard treatment of either doxorubicin hydrochloride triple-negative cancer or anti-estrogen therapy hormone receptor-positive cancer may be an effective treatment for these types of breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate efficacy overall response rate of MK-3475 pembrolizumab and doxorubicin doxorubicin hydrochloride in patients with stage IV triple negative breast cancer
II To evaluate efficacy overall response rate of MK-3475 and an oral aromatase inhibitor in patients with stage IV hormone receptor positive HR human epidermal growth factor receptor 2 negative HER2- breast cancer
SECONDARY OBJECTIVES
I To assess clinical benefit rate lack of progression for 24 weeks duration of response time-to-treatment failure progression-free survival and overall survival in triple negative TN stage IV breast cancer patients based primarily on Response Evaluation Criteria in Solid Tumors RECIST 11 and immune-related irRECIST
II To assess feasibility and toxicity
III To assess clinical benefit rate lack of progression for 24 weeks duration of response time-to-treatment failure progression-free survival and overall survival in patients with stage IV HR breast cancer based primarily on RECIST 11 and irRECIST
IV To assess feasibility and toxicities
TERTIARY OBJECTIVES
I To procure serial tumor primary and metastatic and blood cellular and serumplasma samples and analyze them to better our understanding of cellular and humoral immune response correlates and predictors of clinical benefits leading to optimized selection of target populations in future phase II and subsequent phase III randomized prospective trials
OUTLINE Patients are assigned to 1 of 2 treatment arms
COHORT 1 TRIPLE-NEGATIVE Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 and doxorubicin hydrochloride IV on day 1 Treatment repeats every 3 weeks for 6 courses and then continues for up to 24 months with pembrolizumab alone in the absence of disease progression or unacceptable toxicity
COHORT 2 HORMONEHER2 Patients receive pembrolizumab IV over 30 minutes on day 1 and an aromatase inhibitor exemestane anastrozole or letrozole orally PO once daily QD on days 1-21 Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity
In both arms patients who stop pembrolizumab with stable disease or better may receive additional pembrolizumab therapy for up to 1 year if they progress after stopping study treatment
After completion of study treatment patients are followed up for 30 days after the end of treatment and then every 8-12 weeks thereafter
I To evaluate efficacy overall response rate of MK-3475 pembrolizumab and doxorubicin doxorubicin hydrochloride in patients with stage IV triple negative breast cancer
II To evaluate efficacy overall response rate of MK-3475 and an oral aromatase inhibitor in patients with stage IV hormone receptor positive HR human epidermal growth factor receptor 2 negative HER2- breast cancer
SECONDARY OBJECTIVES
I To assess clinical benefit rate lack of progression for 24 weeks duration of response time-to-treatment failure progression-free survival and overall survival in triple negative TN stage IV breast cancer patients based primarily on Response Evaluation Criteria in Solid Tumors RECIST 11 and immune-related irRECIST
II To assess feasibility and toxicity
III To assess clinical benefit rate lack of progression for 24 weeks duration of response time-to-treatment failure progression-free survival and overall survival in patients with stage IV HR breast cancer based primarily on RECIST 11 and irRECIST
IV To assess feasibility and toxicities
TERTIARY OBJECTIVES
I To procure serial tumor primary and metastatic and blood cellular and serumplasma samples and analyze them to better our understanding of cellular and humoral immune response correlates and predictors of clinical benefits leading to optimized selection of target populations in future phase II and subsequent phase III randomized prospective trials
OUTLINE Patients are assigned to 1 of 2 treatment arms
COHORT 1 TRIPLE-NEGATIVE Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 and doxorubicin hydrochloride IV on day 1 Treatment repeats every 3 weeks for 6 courses and then continues for up to 24 months with pembrolizumab alone in the absence of disease progression or unacceptable toxicity
COHORT 2 HORMONEHER2 Patients receive pembrolizumab IV over 30 minutes on day 1 and an aromatase inhibitor exemestane anastrozole or letrozole orally PO once daily QD on days 1-21 Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity
In both arms patients who stop pembrolizumab with stable disease or better may receive additional pembrolizumab therapy for up to 1 year if they progress after stopping study treatment
After completion of study treatment patients are followed up for 30 days after the end of treatment and then every 8-12 weeks thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15295 | OTHER | City of Hope Medical Center | None |
| NCI-2015-02194 | REGISTRY | None | None |