HR+/HER2- Advanced or Metastatic Breast CancerNCT05853432
A Descriptive Study of Baseline Characteristics, Clinical Outcomes, and Treatment Patterns of HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Alpelisib Plus Fulvestrant Who Have Received Fulvestrant in Any Prior Line of Therapy
An observational study of HR+/HER2- Advanced or Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Ireland.
Trial summary
This was a non-interventional, retrospective cohort study of patients with HR+/HER2- aBC treated with alpelisib (ALP) plus fulvestrant (FUL) who have received fulvestrant in any prior line of therapy (LoT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+/HER2- Advanced or Metastatic Breast Cancer
- How many people
- 157 participants
- Where
- 1 siteIreland
- Study dates
- 16 Mar 2022to 2 May 2022
- 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
- Had a curated record for advanced or metastatic breast cancer diagnosis.
- Note: Diagnosis of a/mBC is based on a curated record of M stage=M1, Stage 4/4a/4b, presence of metastatic tumor, Stage 3b/3c or presence of secondary neoplasm.
- Had patient activity documented in ConcertAI Patient 360 Breast Cancer database (defined as a record of a clinic visit, medication administration, vital test, or lab test) or death within 90 days after the advanced or metastatic breast cancer diagnosis date.
- Had documented receipt of treatment with alpelisib plus fulvestrant on or after the advanced or metastatic diagnosis date.
- Had documented receipt of treatment with fulvestrant before the index date (start date of the earliest alpelisib plus fulvestrant regimen). This included (neo) adjuvant therapies.
- Age ≥18 years on the index date.
Who cannot join
- Had documented hormone receptor-negative (defined as both estrogen receptor-negative and progesterone receptor-negative) or HER2-positive status any time prior to index date (but prioritizing results closest to index date, if there were conflicting results).
- Patient had a clinical trial registration date (i.e., participated in a clinical trial) on or before the index date.
- Patients with "negative" PIK3CA test before index date (in case of multiple tests, the one closer to the index date was used).
Trial locations and contacts
1 site in 1 country.
About this study
This was a non-interventional, retrospective cohort study of patients with HR+/HER2- aBC treated with alpelisib (ALP) plus fulvestrant (FUL) who have received fulvestrant in any prior line of therapy (LoT). This study utilized de-identified individual patient data from the United States (US) ConcertAI Patient360 Breast Cancer database, sourced from electronic health records (EHR) (i.e., secondary use of data). Patients were indexed at their start date of the earliest alpelisib plus fulvestrant regimen and followed until their death date or last confirmed activity date in the absence of an observed death.
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the date of death, or last confirmed activity date in the absence of an observed death event.
Measured: Up to approximately 21 months
Real-world progression-free survival (rwPFS)
rwPFS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the first documented progression or death date occurring at least 14 days after the index date, or last adequate tumor assessment date in the absence of an observed progression or death event.
Measured: Up to approximately 21 months
Line of treatment of ALP+FUL received
Measured: Baseline
Line of treatment number of index regimens stratified by index year
Measured: Baseline
Starting dose of alpelisib
Measured: Baseline
Number of prior regimens
Measured: Baseline
Prior fulvestrant treatment category
Measured: Baseline
Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment
Measured: Baseline
Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant
Measured: Baseline
Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting
Measured: Baseline
Percentage of patients with prior exposure to chemotherapy in the metastatic setting
Measured: Baseline
Time to treatment discontinuation
Measured: Up to approximately 21 months
First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen
Measured: Up to approximately 21 months
Secondary outcomes (13)
Overall survival (OS) in subgroups of patients according to the prior lines of treatment
OS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the date of death, or last confirmed activity date in the absence of an observed death event.
Measured: Up to approximately 21 months
Real-world progression-free survival (rwPFS) in subgroups of patients according to the prior lines of treatment
rwPFS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the first documented progression or death date occurring at least 14 days after the index date, or last adequate tumor assessment date in the absence of an observed progression or death event.
Measured: Up to approximately 21 months
Line of treatment of ALP+FUL received in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Line of treatment number of index regimens stratified by index year in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Starting dose of alpelisib in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Number of prior regimens in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Prior fulvestrant treatment category in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Percentage of patients with prior exposure to chemotherapy in the metastatic setting in subgroups of patients according to the prior lines of treatment
Measured: Baseline
Time to treatment discontinuation in subgroups of patients according to the prior lines of treatment
Measured: Up to approximately 21 months
First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen in subgroups of patients according to the prior lines of treatment
Measured: Up to approximately 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start16 Mar 2022
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Advanced or Metastatic 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
- 157 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
- NCT05853432
- Sponsor's protocol ID
- CBYL719C2009
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of Baseline Characteristics, Clinical Outcomes, and Treatment Patterns of HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Alpelisib Plus Fulvestrant Who Have Received Fulvestrant in Any Prior Line of Therapy
- ClinicalTrials.gov ID
- NCT05853432
- Acronym / sponsor ID
- CBYL719C2009
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 10 May 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 non-interventional, retrospective cohort study of patients with HR+/HER2- aBC treated with alpelisib (ALP) plus fulvestrant (FUL) who have received fulvestrant in any prior line of therapy (LoT). This study utilized de-identified individual patient data from the United States (US) ConcertAI Patient360 Breast Cancer database, sourced from electronic health records (EHR) (i.e., secondary use of data). Patients were indexed at their start date of the earliest alpelisib plus fulvestrant regimen and followed until their death date or last confirmed activity date in the absence of an observed death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
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 (6 listed)
- Had a curated record for advanced or metastatic breast cancer diagnosis.
- Note: Diagnosis of a/mBC is based on a curated record of M stage=M1, Stage 4/4a/4b, presence of metastatic tumor, Stage 3b/3c or presence of secondary neoplasm.
- Had patient activity documented in ConcertAI Patient 360 Breast Cancer database (defined as a record of a clinic visit, medication administration, vital test, or lab test) or death within 90 days after the advanced or metastatic breast cancer diagnosis date.
- Had documented receipt of treatment with alpelisib plus fulvestrant on or after the advanced or metastatic diagnosis date.
- Had documented receipt of treatment with fulvestrant before the index date (start date of the earliest alpelisib plus fulvestrant regimen). This included (neo) adjuvant therapies.
Key exclusion criteria (3 listed)
- Had documented hormone receptor-negative (defined as both estrogen receptor-negative and progesterone receptor-negative) or HER2-positive status any time prior to index date (but prioritizing results closest to index date, if there were conflicting results).
- Patient had a clinical trial registration date (i.e., participated in a clinical trial) on or before the index date.
- Patients with "negative" PIK3CA test before index date (in case of multiple tests, the one closer to the index date was used).
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
Overall survival (OS)
Time frame: Up to approximately 21 months
OS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the date of death, or last confirmed activity date in the absence of an observed death event.
Real-world progression-free survival (rwPFS)
Time frame: Up to approximately 21 months
rwPFS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the first documented progression or death date occurring at least 14 days after the index date, or last adequate tumor assessment date in the absence of an observed progression or death event.
Line of treatment of ALP+FUL received
Time frame: Baseline
Line of treatment number of index regimens stratified by index year
Time frame: Baseline
Starting dose of alpelisib
Time frame: Baseline
Number of prior regimens
Time frame: Baseline
Prior fulvestrant treatment category
Time frame: Baseline
Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment
Time frame: Baseline
Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant
Time frame: Baseline
Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting
Time frame: Baseline
Percentage of patients with prior exposure to chemotherapy in the metastatic setting
Time frame: Baseline
Time to treatment discontinuation
Time frame: Up to approximately 21 months
First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen
Time frame: Up to approximately 21 months
13 secondary outcomes
Overall survival (OS) in subgroups of patients according to the prior lines of treatment
Time frame: Up to approximately 21 months
Real-world progression-free survival (rwPFS) in subgroups of patients according to the prior lines of treatment
Time frame: Up to approximately 21 months
Line of treatment of ALP+FUL received in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Line of treatment number of index regimens stratified by index year in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Starting dose of alpelisib in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Number of prior regimens in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Prior fulvestrant treatment category in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Percentage of patients with prior exposure to chemotherapy in the metastatic setting in subgroups of patients according to the prior lines of treatment
Time frame: Baseline
Time to treatment discontinuation in subgroups of patients according to the prior lines of treatment
Time frame: Up to approximately 21 months
First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen in subgroups of patients according to the prior lines of treatment
Time frame: Up to approximately 21 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 10 May 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 HR+/HER2- Advanced or Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Ireland.
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 6 inclusion and 3 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 10 May 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 Ireland. 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?
Overall survival (OS) (time frame: Up to approximately 21 months). The study lists 13 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 10 May 2023.