Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
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ClinicalTrials.gov Identifier: NCT02738866 |
Recruitment Status :
Recruiting
First Posted : April 14, 2016
Last Update Posted : January 12, 2021
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Tracking Information | |||||||||
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First Submitted Date ICMJE | April 11, 2016 | ||||||||
First Posted Date ICMJE | April 14, 2016 | ||||||||
Last Update Posted Date | January 12, 2021 | ||||||||
Actual Study Start Date ICMJE | October 25, 2016 | ||||||||
Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor | ||||||||
Official Title ICMJE | Phase II Trial of Palbociclib With Fulvestrant in Individuals With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Who Have Progressed on Treatment With Palbociclib and an Aromatase Inhibitor | ||||||||
Brief Summary | This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase inhibitor. | ||||||||
Detailed Description | In this phase II trial, the primary objective is to determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). The study will also determine the prevalence rate of estrogen receptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population. The secondary objectives include evaluating the progression-free survival (PFS) in participants with and without ESR1 mutations, and PI3K mutations through analysis of tumor biopsies and circulating plasma tumor DNA (ptDNA) samples. The study will also describe other alterations in genes and gene products relevant to the cell cycle, drug targets, tumor sensitivity and resistance, and identify novel protein kinases activated in biopsies from participants with hormone refractory MBC who progressed on prior palbociclib and AI. The data will be correlated with tumor subtypes, expression profiles, and candidate phosphoprotein expression with PFS in the study population. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Palbociclib and Fulvestrant
Participants will receive fulvestrant with palbociclib until disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
100 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 2023 | ||||||||
Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02738866 | ||||||||
Other Study ID Numbers ICMJE | J15212 IRB00086616 ( Other Identifier: JHMIRB ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |