Metastatic Breast CancerNCT06607601
CARE Initiative: Real-world Emulation of the PALOMA-2 Trial
An observational study of Metastatic Breast Cancer, run by Aetion, Inc..
Trial summary
The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer using real-world, electronic health record data. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palbociclib and Letrozole
- How many people
- 724 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2010to 20 Jul 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients identified in the electronic health record data source with metastatic ER+/HER2- breast cancer initiating treatment with the study drugs (palbociclib, letrozole)
Who may be able to join
- Breast cancer diagnosis
- Histology not indicative of non-adenocarcinoma histologies
- Metastatic disease
- Estrogen-receptor positive (ER+)
- No prior systemic treatment for metastatic breast cancer
- Post-menopausal
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or missing or Karnofsky performance status \>=50 or missing
- No lab results indicating inadequate organ function, as defined in the PALOMA-2 RCT protocol
Who cannot join
- Human epidermal growth factor receptor 2 (HER2) positive tumor
- Diagnosis of brain, central nervous system, and/or spinal cord metastases
- Neoadjuvant or adjuvant treatment with anastrozole or letrozole ≤12 months before metastatic diagnosis
- Prior treatment with treatment with ribociclib, abemaciclib, or palbociclib
- Treatment with a CYP3A4 inhibitor or inducer or drugs known to prolong the QT interval, as specified in the PALOMA-2 trial protocol, in the 7 days prior to study treatment initiation
- Anti-cancer therapy or major cancer-related surgery within 2 weeks before study treatment initiation
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- Diagnosis of a second primary malignancy within 3 years prior to study treatment initiation
- Diagnosis of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes
- Diagnosis of hypocalcemia, hypokalemia, or hypomagnesemia
- Diagnosis of myocardial infarction, angina, ongoing cardiac dysrhythmias, atrial fibrillation, congestive heart failure, cerebral infarction, transient ischemic attack, or pulmonary embolism in the 6 months prior to study treatment initiation
- Diagnosis of inflammatory bowel disease chronic diarrhea, or short bowel syndrome
- Diagnosis of human immunodeficiency virus infection
About this study
Official title: CARE Initiative Study: Real-world Emulation of the PALOMA-2 Comparative Effectiveness Trial of Palbociclib and Letrozole vs. Placebo and Letrozole for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer using real-world, electronic health record data. The main questions this study aims to answer are:
- Do patients with metastatic ER+/HER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival (rwPFS) compared with patients treated with letrozole alone?
- How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial?
Read the detailed description
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (RWD) in clinical and regulatory decision-making. Using randomized controlled trials (RCT) as a benchmark for causal effect estimates, a series of RCT emulations will be conducted across varying trials, real world data sources, and study design elements to better understand under what conditions non-interventional studies, using data generated during routine clinical care, can provide reliable conclusions about drug effectiveness.
In this study, real-world electronic health record (EHR) data will be used to emulate the Palbociclib: Ongoing Trials in the Management of Breast Cancer (PALOMA-2) efficacy trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.2 Similarly to the PALOMA-2 trial, this study will compare real-world progression-free survival (rwPFS) between patients who initiate palbociclib and letrozole and those initiating letrozole alone.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palbociclib, Letrozole
- Keywords
- real-world evidence, real-world data, oncology, pharmacoepidemiology, comparative effectiveness research, trial emulation
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Treatment information in the electronic health record indicates initiation of palbociclib after metastatic diagnosis
LetrozoleDrug
Treatment information in the electronic health record indicates initiation of letrozole after metastatic diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Patients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer Receives: Drug: Palbociclib; Drug: Letrozole | |
| Comparator | Patients initiating treatment with letrozole as first-line treatment for metastatic ER+/HER2- breast cancer Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world progression-free survival (rwPFS)
Time from study treatment initiation to disease progression or death
Measured: From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 33 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Feb 2010
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aetion, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, Amgen, AstraZeneca, Bayer, Gilead Sciences, Janssen, LP, Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607601
- Sponsor's protocol ID
- DS3-PALOMA2
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
PubMed 27959613
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE Initiative Study: Real-world Emulation of the PALOMA-2 Comparative Effectiveness Trial of Palbociclib and Letrozole vs. Placebo and Letrozole for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06607601
- Acronym / sponsor ID
- DS3-PALOMA2
- Conditions
- Metastatic Breast Cancer
- Keywords
- real-world evidence, real-world data, oncology, pharmacoepidemiology, comparative effectiveness research, trial emulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Aetion, Inc.University, hospital or other
- Collaborators
- AbbVie, Amgen, AstraZeneca, Bayer, Gilead Sciences, Janssen, LP, Pfizer
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 23 Sep 2024 (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 goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer using real-world, electronic health record data. The main questions this study aims to answer are:
- Do patients with metastatic ER+/HER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival (rwPFS) compared with patients treated with letrozole alone?
- How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial?
Detailed description
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (RWD) in clinical and regulatory decision-making. Using randomized controlled trials (RCT) as a benchmark for causal effect estimates, a series of RCT emulations will be conducted across varying trials, real world data sources, and study design elements to better understand under what conditions non-interventional studies, using data generated during routine clinical care, can provide reliable conclusions about drug effectiveness.
In this study, real-world electronic health record (EHR) data will be used to emulate the Palbociclib: Ongoing Trials in the Management of Breast Cancer (PALOMA-2) efficacy trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.2 Similarly to the PALOMA-2 trial, this study will compare real-world progression-free survival (rwPFS) between patients who initiate palbociclib and letrozole and those initiating letrozole alone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Drug: Palbociclib, Drug: LetrozolePatients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer |
| Comparator | – | Drug: LetrozolePatients initiating treatment with letrozole as first-line treatment for metastatic ER+/HER2- breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients identified in the electronic health record data source with metastatic ER+/HER2- breast cancer initiating treatment with the study drugs (palbociclib, letrozole)
Key inclusion criteria (8 listed)
- Breast cancer diagnosis
- Histology not indicative of non-adenocarcinoma histologies
- Metastatic disease
- Estrogen-receptor positive (ER+)
- No prior systemic treatment for metastatic breast cancer
Key exclusion criteria (12 listed)
- Human epidermal growth factor receptor 2 (HER2) positive tumor
- Diagnosis of brain, central nervous system, and/or spinal cord metastases
- Neoadjuvant or adjuvant treatment with anastrozole or letrozole ≤12 months before metastatic diagnosis
- Prior treatment with treatment with ribociclib, abemaciclib, or palbociclib
- Treatment with a CYP3A4 inhibitor or inducer or drugs known to prolong the QT interval, as specified in the PALOMA-2 trial protocol, in the 7 days prior to study treatment initiation
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 |
|---|---|---|
| PalbociclibTreatment information in the electronic health record indicates initiation of palbociclib after metastatic diagnosis | Drug | Exposed |
| LetrozoleTreatment information in the electronic health record indicates initiation of letrozole after metastatic diagnosis | Drug | Comparator, Exposed |
Primary outcome
Real-world progression-free survival (rwPFS)
Time frame: From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 33 months.
Time from study treatment initiation to disease progression or death
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 23 Sep 2024.
- Background: PubMed 27959613Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Aetion, Inc..
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 8 inclusion and 12 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 23 Sep 2024. 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?
Real-world progression-free survival (rwPFS) (time frame: From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 33 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607601, which also lists 1 linked publication.
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 23 Sep 2024.