Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03213041|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Negative Estrogen Receptor Positive HER2/Neu Negative Progesterone Receptor Negative Recurrent Breast Carcinoma Stage IV Breast Cancer Triple-Negative Breast Carcinoma||Drug: Carboplatin Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. Evaluate the impact on progression free survival (PFS) of the combination pembrolizumab - carboplatin in patients with circulating tumor cells (CTC) positive, HER2 negative metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes in primary setting.
I. Evaluate the impact on overall survival (OS) of the combination carboplatin - pembrolizumab in patients with CTC positive MBC previously treated with anthracyclines and taxanes in primary setting.
II. To assess the overall response rate or objective response rate (ORR) and clinical benefit rate (CBR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with carboplatin - pembrolizumab in patients with CTC positive MBC previously treated with anthracyclines and taxanes in primary setting.
III. To assess immune-related response using tumor response by immune-related RECIST (irRECIST) as immune-related partial response (irPR) or immune-related complete response (irCR).
IV. Measure the time to new metastases (TTNM). V. Evaluate ORR and clinical benefit in relation to PDL-1 expression in tissue and CTCs.
I. Measure immune biomarkers (PDL-1) in CTCs (CellSearch) and immune cells such as cancer-associated macrophage-like cells (CAMLs) (CellSieve) and correlate with therapeutic benefit.
II. Measure cell-free circulating tumor deoxyribonecleic acid (ctDNA) and T-cell receptor sequencing analysis and correlate them with CTC enumeration and therapeutic benefit.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days, every 9 weeks for 1 year, and then every 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)|
|Actual Study Start Date :||September 14, 2017|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Treatment (pembrolizumab, carboplatin)
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Progression Free Survival (PFS) [ Time Frame: Every 9 weeks from the first study treatment, assessed up to 3 years ]Use imaging to evaluate the PFS for patients with CTC positive, HER2 negative MBC treated with the combination pembrolizumab - carboplatin.
- Overall Survival (OS) [ Time Frame: Up to 3 years ]Assess the combination Carboplatin - pembrolizumab on OS.
- Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]Evaluate the ORR according to RECIST criteria.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 3 years ]CBR will be evaluated according to RECIST criteria.
- Immune-related response [ Time Frame: Up to 3 years ]Immune-related response defined as irPR or irCR and assessed by irRECIST.
- Immune-related clinical benefit rate [ Time Frame: Up to 3 years ]Immune-related clinical benefit rate defined as immune-related stable disease (irSD), irPR or irCR and assessed by irRECIST.
- Time to New Metastases (TTNM) [ Time Frame: Up to 3 years ]The time to new metastases will be measured.
- ORR in relation to PDL-1 expression [ Time Frame: Up to 3 years ]ORR will be evaluated in relation to PDL-1 expression in tissue and CTCs.
- CBR in relation to PDL-1 expression [ Time Frame: Up to 3 years ]CBR will be evaluated in relation to PDL-1 expression in tissue and CTCs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213041
|Contact: Study Coordinator||(312)firstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Massimo Cristofanilli, MD 312-503-5488 Massimo.email@example.com|
|Principal Investigator: Massimo Cristofanilli, MD|
|Sub-Investigator: Cesar A. Santa-Maria, MD|
|Sub-Investigator: Sarika Jain, MD|
|Sub-Investigator: William J. Gradishar, MD|
|Sub-Investigator: Lisa Flaum, MD|
|Sub-Investigator: Claudia Tellez, MD|
|Principal Investigator:||Massimo Cristofanilli, MD||Northwestern University|