Breast CancerNCT05982886
Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 1,093 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 1 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer,, PIK3CA,, Alpelisib,, non-interventional study,, HR+
- Medical subject headings
- Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PIK3CA positive: HR+ Her2- | Not described | |
| PIK3CA positive: HR- Her2- | Not described | |
| PIK3CA positive: HR- Her2+ | Not described | |
| PIK3CA positive: HR+ Her2+ | Not described | |
| PIK3CA negative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with PIK3CA mutations
Measured: Up to approximately 6 years
Time from first BC diagnosis to first PIK3CA evaluation
Measured: Up to approximately 6 years
Time from advanced BC diagnosis to first PIK3CA evaluation
Measured: Up to approximately 6 years
Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation
Measured: Up to approximately 6 years
Number of tests for patients with CDK4/6 inhibitor treatment
Measured: Up to approximately 6 years
Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
Measured: Up to approximately 6 years
Year of (first, where applicable) PIK3CA evaluation
Measured: Up to approximately 6 years
Result of PIK3CA evaluation (negative, positive, unknown)
Measured: Up to approximately 6 years
Type of biopsy
Measured: Up to approximately 6 years
Type of tissue sample, for patients who had tissue biopsy
Measured: Up to approximately 6 years
Source of tissue sample, for patients who had tissue biopsy
Measured: Up to approximately 6 years
Analytical method used for PIK3CA evaluation
Measured: Up to approximately 6 years
Secondary outcomes (14)
Age at advanced breast cancer diagnosis
Measured: Up to approximately 6 years
Stage when patients were diagnosed with BC
Measured: Up to approximately 6 years
Number of patients with known metastatic sites
Measured: Up to approximately 6 years
Performance as assessed by Karnofsky Performace Scale
The Karnofsky Performance Scale is a measure of functional impairment.
Measured: Up to approximately 6 years
Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
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.
Measured: Up to approximately 6 years
Height
Measured: Up to approximately 6 years
Weight
Measured: Up to approximately 6 years
Body mass index (BMI)
Measured: Up to approximately 6 years
Number of patients per stage of cancer
Measured: Up to approximately 6 years
Number of patients per line of treatment
Measured: Up to approximately 6 years
Time from advanced diagnosis to initiation of lines of treatment
Measured: Up to approximately 6 years
Number of patients per systemic therapy
Measured: Up to approximately 6 years
Number of patients per treatment sequence
Measured: Up to approximately 6 years
Number of patients per supportive treatment
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Jan 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982886
- Sponsor's protocol ID
- CBYL719A0US11
- Status last verified
- Jul 2023
- First submitted
- 1 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05982886
- Acronym / sponsor ID
- CBYL719A0US11
- Conditions
- Breast Cancer
- Keywords
- Breast cancer,, PIK3CA,, Alpelisib,, non-interventional study,, HR+
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,093 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 9 Aug 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PIK3CA positive: HR+ Her2- | – | – |
| PIK3CA positive: HR- Her2- | – | – |
| PIK3CA positive: HR- Her2+ | – | – |
| PIK3CA positive: HR+ Her2+ | – | – |
| PIK3CA negative | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with PIK3CA mutations
Time frame: Up to approximately 6 years
Time from first BC diagnosis to first PIK3CA evaluation
Time frame: Up to approximately 6 years
Time from advanced BC diagnosis to first PIK3CA evaluation
Time frame: 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
Number of tests for patients with CDK4/6 inhibitor treatment
Time frame: Up to approximately 6 years
Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
Time frame: Up to approximately 6 years
Year of (first, where applicable) PIK3CA evaluation
Time frame: Up to approximately 6 years
Result of PIK3CA evaluation (negative, positive, unknown)
Time frame: Up to approximately 6 years
Type of biopsy
Time frame: Up to approximately 6 years
Type of tissue sample, for patients who had tissue biopsy
Time frame: Up to approximately 6 years
Source of tissue sample, for patients who had tissue biopsy
Time frame: Up to approximately 6 years
Analytical method used for PIK3CA evaluation
Time frame: Up to approximately 6 years
14 secondary outcomes
Age at advanced breast cancer diagnosis
Time frame: Up to approximately 6 years
Stage when patients were diagnosed with BC
Time frame: Up to approximately 6 years
Number of patients with known metastatic sites
Time frame: Up to approximately 6 years
Performance as assessed by Karnofsky Performace Scale
Time frame: 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
Height
Time frame: Up to approximately 6 years
Weight
Time frame: Up to approximately 6 years
Body mass index (BMI)
Time frame: Up to approximately 6 years
Number of patients per stage of cancer
Time frame: Up to approximately 6 years
Number of patients per line of treatment
Time frame: Up to approximately 6 years
Time from advanced diagnosis to initiation of lines of treatment
Time frame: Up to approximately 6 years
Number of patients per systemic therapy
Time frame: Up to approximately 6 years
Number of patients per treatment sequence
Time frame: Up to approximately 6 years
Number of patients per supportive treatment
Time frame: Up to approximately 6 years
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 9 Aug 2023.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
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 10 inclusion and 1 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 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of patients with PIK3CA mutations (time frame: Up to approximately 6 years). The study lists 12 primary outcomes in all. 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 9 Aug 2023.