Metastatic Breast CancerNCT03285568
Patterns of Prescribing and Monitoring of Palbociclib
An observational study of Metastatic Breast Cancer and Advanced Breast Cancer, run by Rush University Medical Center.
Trial summary
The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Metastatic Breast Cancer, Advanced Breast Cancer, Estrogen Receptor-positive Breast Cancer
- What is being tested?
- Palbociclib
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2015to 30 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients seen at RUMC
Who may be able to join
- women at least 18 years old
- ER+, HER2- advanced breast cancer
- receiving palbociclib
Who cannot join
- brain metastases
- on palbociclib clinical trial
About this study
The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.
Read the detailed description
This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.
The primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.
The secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Estrogen Receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Being tested
- Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called IBRANCE
Observe patients receiving palbociclib for dose adjustment and lab monitoring
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib | women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palbociclib dose according to the package insert recommendations.
Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.
Measured: 22 months
Secondary outcomes (5)
Dose adjustment for hematologic toxicities
Number of patients who required dose adjustment for hematologic toxicities while on the study.
Measured: 22 months
Number of patients who experienced neutropenia.
Patients who experienced neutropenia as a result of their participation in the study.
Measured: 22 months
Duration of therapy
Number of patients who completed the study compared to the number of patients who were was discontinued with the most common reason for discontinuation being disease progression
Measured: 22 months
Progression free survival (PFS)
Progression free survival duration of patients that were in the study who received Palbociclib
Measured: 22 months
Adherence to manufacturer monitoring recommendations
Patient adherence was also a limitation of this study as providers relied on the patient report to track medication adherence. Insurance coverage and access to palbociclib also contributed some variability as there were occasional delays in initiation of therapy or change in dose.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start3 Feb 2015
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Schultz, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285568
- Sponsor's protocol ID
- 16082509
- Status last verified
- Mar 2023
- First submitted
- 14 Sep 2017
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Prescribing and Monitoring of Palbociclib
- ClinicalTrials.gov ID
- NCT03285568
- Acronym / sponsor ID
- 16082509
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Estrogen Receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.
Detailed description
This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.
The primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.
The secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib | – | Drug: Palbociclibwomen at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients seen at RUMC
Key inclusion criteria (3 listed)
- women at least 18 years old
- ER+, HER2- advanced breast cancer
- receiving palbociclib
Key exclusion criteria (2 listed)
- brain metastases
- on palbociclib clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalbociclibAlso: IBRANCEObserve patients receiving palbociclib for dose adjustment and lab monitoring | Drug | Palbociclib |
Primary outcome
Palbociclib dose according to the package insert recommendations.
Time frame: 22 months
Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.
5 secondary outcomes
Dose adjustment for hematologic toxicities
Time frame: 22 months
Number of patients who experienced neutropenia.
Time frame: 22 months
Duration of therapy
Time frame: 22 months
Progression free survival (PFS)
Time frame: 22 months
Adherence to manufacturer monitoring recommendations
Time frame: 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Schultz principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Advanced Breast Cancer, run by Rush University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palbociclib dose according to the package insert recommendations. (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.