Metastatic Breast CancerNCT05012644

Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone

An observational study of Metastatic Breast Cancer, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: Palbociclib + aromatase inhibitor and Aromatase inhibitor
How many people: 197 participants
Where: 1 siteUnited States
Study dates: 16 Jul 2021to 9 Dec 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: pre-menopausal metastatic breast cancer patients

Who may be able to join

Pre or perimenopausal at MBC diagnosis
Diagnosis of MBC in patient history
Confirmed HR+/HER2- status as defined as: a. HR+: ER+ or PR+ test; b. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, fluorescence in situ hybridization [FISH] positive/amplified, positive not otherwise specified [NOS]).
Received one of the following regimens as first-line treatment for MBC during the period from 01 January 2010 through index period 30 June 2020 until the data cutoff date of 31 December 2020.
Palbociclib + AI as first-line treatment for MBC or
Monotherapy AI as first-line treatment for MBC
Received care at a US Oncology Network (USON) site(s) utilizing the full EHR capacities of iKnowMed (iKM) at the time of treatment.
EHR data available from the USON site(s) where the patient received treatment are accessible for research purposes.

Who cannot join

Evidence of prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors (palbociclib, ribociclib or abemaciclib) in the early breast cancer (BC) or MBC setting.
First structured activity (clinical visit) greater than 120 days after MBC diagnostic date with chart review to confirm no initial MBC treatment outside USON.
Receipt of treatment indicated for another primary cancer during the study observation period (after initiation of Palbociclib + AI or AI monotherapy and before 31 December 2020) or history of another primary cancer within USON.
Enrolled in any interventional clinical trial after initiation of Palbociclib + AI or AI monotherapy AND before 31 December 2020.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer New York
New York, New York, 10017

Other trials in United States

About this study

Official title: REAL-WORLD TUMOR RESPONSE OF PALBOCICLIB IN COMBINATION WITH AN AROMATASE INHIBITOR AS FIRST-LINE THERAPY IN PRE/PERIMENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER

This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obtained from structured data fields within an electronic health record (EHR) database and will be supplemented by additional unstructured data collected through a targeted chart review.

Conditions: Metastatic Breast Cancer
Being tested: Palbociclib + aromatase inhibitor, Aromatase inhibitor
Keywords: pre-menopausal, palbociclib, aromatase inhibitor
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Palbociclib + aromatase inhibitorDrug
Palbociclib + aromatase inhibitor
Aromatase inhibitorDrug
Aromatase inhibitor

Study groups in NCT05012644
Study group	Role	What they receive
Palbociclib + aromatase inhibitor		Palbociclib + aromatase inhibitor Receives: Drug: Palbociclib + aromatase inhibitor
Aromatase inhibitor alone		Aromatase inhibitor alone Receives: Drug: Aromatase inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Real World Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW])
rwTR of complete response (CR) or partial response (PR) based on response assessments captured with chart review during first line therapy. Real-world response rate (rwRR) was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases.
Measured: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.
Real World Tumor Response in Patients With Tumor Assessment (Adjusted by nIPTW)
rwTR of complete CR or PR based on response assessments captured with chart review during first line therapy. rwRR was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases.
Measured: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 20219 Dec 2021

First posted19 Aug 2021
Study start16 Jul 2021
Primary completion9 Dec 2021
Study completion9 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by PfizerThe 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: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05012644
Sponsor's protocol ID: A5481159
Status last verified: Jul 2024
First submitted: 12 Aug 2021
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

DeMichele A, Robert N, Chen C, Kim S, Zhang Z, Lu DR, Aguilar KM, Wang Y, Li B, Schneeweiss S, Rassen JA, Gaffney M, McRoy L. Real-World Tumor Response of Palbociclib in Combination With an Aromatase Inhibitor as First-Line Therapy in Pre/Perimenopausal Women With Metastatic Breast Cancer. Target Oncol. 2023 Jul;18(4):543-558. doi: 10.1007/s11523-023-00979-1. Epub 2023 Jul 10.
PubMed 37428347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REAL-WORLD TUMOR RESPONSE OF PALBOCICLIB IN COMBINATION WITH AN AROMATASE INHIBITOR AS FIRST-LINE THERAPY IN PRE/PERIMENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER
ClinicalTrials.gov ID: NCT05012644
Acronym / sponsor ID: A5481159
Conditions: Metastatic Breast Cancer
Keywords: pre-menopausal, palbociclib, aromatase inhibitor
Study type: Observational
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 16 Jul 2021 (actual)
Primary completion: 9 Dec 2021 (actual)
Study completion: 9 Dec 2021 (actual)
First posted: 19 Aug 2021 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Palbociclib + aromatase inhibitor	–	Drug: Palbociclib + aromatase inhibitorPalbociclib + aromatase inhibitor
Aromatase inhibitor alone	–	Drug: Aromatase inhibitorAromatase inhibitor alone

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: pre-menopausal metastatic breast cancer patients

Key inclusion criteria (8 listed)

Pre or perimenopausal at MBC diagnosis
Diagnosis of MBC in patient history
Confirmed HR+/HER2- status as defined as: a. HR+: ER+ or PR+ test; b. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, fluorescence in situ hybridization [FISH] positive/amplified, positive not otherwise specified [NOS]).
Received one of the following regimens as first-line treatment for MBC during the period from 01 January 2010 through index period 30 June 2020 until the data cutoff date of 31 December 2020.
Received care at a US Oncology Network (USON) site(s) utilizing the full EHR capacities of iKnowMed (iKM) at the time of treatment.

Key exclusion criteria (4 listed)

Evidence of prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors (palbociclib, ribociclib or abemaciclib) in the early breast cancer (BC) or MBC setting.
First structured activity (clinical visit) greater than 120 days after MBC diagnostic date with chart review to confirm no initial MBC treatment outside USON.
Receipt of treatment indicated for another primary cancer during the study observation period (after initiation of Palbociclib + AI or AI monotherapy and before 31 December 2020) or history of another primary cancer within USON.
Enrolled in any interventional clinical trial after initiation of Palbociclib + AI or AI monotherapy AND before 31 December 2020.

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
Palbociclib + aromatase inhibitorPalbociclib + aromatase inhibitor	Drug	Palbociclib + aromatase inhibitor
Aromatase inhibitorAromatase inhibitor	Drug	Aromatase inhibitor alone

Primary outcome

Real World Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW])
Time frame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.
rwTR of complete response (CR) or partial response (PR) based on response assessments captured with chart review during first line therapy. Real-world response rate (rwRR) was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases.
Real World Tumor Response in Patients With Tumor Assessment (Adjusted by nIPTW)
Time frame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.
rwTR of complete CR or PR based on response assessments captured with chart review during first line therapy. rwRR was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases.

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palbociclib + AI	116	1
AI Monotherapy	80	0

Primary outcome: Real World Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW])

Time frame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.. Number. Unit: Percentage of Participants

Measure	Palbociclib + AI n = 116	AI Monotherapy n = 80
Value	52.1	46.2

Palbociclib + AI vs AI Monotherapy: Odds Ratio (OR): 1.266 (95% CI 0.715 to 2.241)

Population analysed: Pre/perimenopausal patients who were treated with palbociclib plus AI or AI monotherapy as first-line treatment for HR positive, HER2 negative MBC in the US clinical practice setting from the USON database who met the inclusion/exclusion criteria of the study protocol. The study period began at patients' starting date of the first-line MBC treatment during the period of 01 January 2010 through 30 June 2020 to study end (data cutoff 31 December 2020).

Primary outcome: Real World Tumor Response in Patients With Tumor Assessment (Adjusted by nIPTW)

Time frame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.. Number. Unit: Percentage of Participants

Measure	Palbociclib + AI n = 103	AI Monotherapy n = 71
Value	60.0	49.9

Palbociclib + AI vs AI Monotherapy: Odds Ratio (OR): 1.508 (95% CI 0.819 to 2.774)

Population analysed: A subgroup of patients with at least 1 tumor assessment on treatment, from pre/perimenopausal patients treated with palbociclib plus AI or AI monotherapy as first-line treatment for HR positive, HER2 negative MBC in the US clinical practice setting from the USON database who met the eligibility of the study protocol. Began at patients' starting date of the first-line MBC treatment from 01 January 2010 to 30 June 2020 to study end (data cutoff 31 December 2020).

Adverse events

Time frame: 11 Years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib + AI	0 of 116 (0%)	0 of 116 (0%)	27 of 116
AI Monotherapy	0 of 80 (0%)	0 of 80 (0%)	38 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37428347DeMichele A, Robert N, Chen C, Kim S, Zhang Z, Lu DR, Aguilar KM, Wang Y, Li B, Schneeweiss S, Rassen JA, Gaffney M, McRoy L. Real-World Tumor Response of Palbociclib in Combination With an Aromatase Inhibitor as First-Line Therapy in Pre/Perimenopausal Women With Metastatic Breast Cancer. Target Oncol. 2023 Jul;18(4):543-558. doi: 10.1007/s11523-023-00979-1. Epub 2023 Jul 10.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Metastatic Breast Cancer

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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.

Pfizer CT.gov Call Center study director

Pfizer

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 Metastatic Breast Cancer, run by Pfizer 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 8 inclusion and 4 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 8 Oct 2024. 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?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW]) (time frame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.). The study lists 2 primary outcomes in all. 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 NCT05012644, 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 8 Oct 2024.