Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer

August 1, 2023 updated by: Novartis Pharmaceuticals
This was a retrospective observational study of patients with advanced breast cancer (BC). This non-interventional study was conducted using discrete structured data and medical record abstraction, if needed, from patients treated at Texas Oncology, the designated research organization and a community oncology practice. The first date of a new diagnosis of advanced BC (de novo or progressed to advanced BC) defined the study index date. To allow for an adequate potential duration of follow-up (retrospectively observed) after the index date over which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of 6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was required.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1093

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria:

  • Patients who met the following criteria were eligible for abstraction:
  • Newly diagnosed advanced BC between 01 January 2015, and 30 June 2020
  • Evaluated for a PIK3CA mutation and identified PIK3CA gene status
  • No evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced BC
  • At least 18 years of age at the time of first diagnosis of BC
  • Patients may be alive or deceased at the time of abstraction

  • Not ever enrolled in the following interventional clinical trials evaluating PI3K inhibitors:

    • SOLAR-1 trial (NCT0243731) evaluating alpelisib (BYL719)
    • BELLE-2 or BELLE-3 trial (NCT01610284, NCT01633060) evaluating buparlisib (BKM120)
    • SANDPIPER trial (NCT02340221) evaluating taselisib (GDC-0032)

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
PIK3CA positive: HR+ Her2-
PIK3CA positive: HR- Her2-
PIK3CA positive: HR- Her2+
PIK3CA positive: HR+ Her2+
PIK3CA negative

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients with PIK3CA mutations
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Time from first BC diagnosis to first PIK3CA evaluation
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Time from advanced BC diagnosis to first PIK3CA evaluation
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of tests for patients with CDK4/6 inhibitor treatment
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Year of (first, where applicable) PIK3CA evaluation
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Result of PIK3CA evaluation (negative, positive, unknown)
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Type of biopsy
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Type of tissue sample, for patients who had tissue biopsy
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Source of tissue sample, for patients who had tissue biopsy
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Analytical method used for PIK3CA evaluation
Time Frame: Up to approximately 6 years
Up to approximately 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age at advanced breast cancer diagnosis
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Stage when patients were diagnosed with BC
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of patients with known metastatic sites
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Performance as assessed by Karnofsky Performace Scale
Time Frame: Up to approximately 6 years
The Karnofsky Performance Scale is a measure of functional impairment.
Up to approximately 6 years
Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Time Frame: Up to approximately 6 years
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Up to approximately 6 years
Height
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Weight
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Body mass index (BMI)
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of patients per stage of cancer
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of patients per line of treatment
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Time from advanced diagnosis to initiation of lines of treatment
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of patients per systemic therapy
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of patients per treatment sequence
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Number of patients per supportive treatment
Time Frame: Up to approximately 6 years
Up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBYL719A0US11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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