Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer

An observational study of 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.

Trial summary

This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by participating providers from Cardinal Health's Oncology Provider Extended Network (OPEN). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: Talazoparib
How many people: 84 participants
Where: 1 siteUnited States
Study dates: 20 Aug 2021to 11 Oct 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
All sexes
No healthy volunteers
Adult, Older adult

Study population: The primary population for this study includes: -HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Who may be able to join

Diagnosed with HER2-negative ABC
gBRCA1/2 mutation(s)
Treatment with talazoparib monotherapy initiated on or after October 16, 2018
-≥18 years of age at initiation of talazoparib
A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period

Who cannot join

Participation in any BC clinical trial after initiation of talazoparib
Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy
gBRCA1/2 or HER2 status unknown
Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Inc
New York, New York, 10017

Other trials in United States

About this study

Official title: Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Talazoparib-Treated Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer and Germline BRCA1/2 Mutations: US Chart Review

This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US.

The primary population for this study includes:

-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Conditions: Breast Cancer
Being tested: Talazoparib
Keywords: Talazoparib, Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

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

TalazoparibDrug
Also called TALZENNA®
This retrospective chart review study focuses on patients with HER2- ABC with gBRCA1/2m initiating talazoparib on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Study groups in NCT04987931
Study group	Role	What they receive
Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m		HER2-negative ABC patients with gBRCA1/2 mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib. Receives: Drug: Talazoparib

What is being measured

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

Time to Treatment Failure (TTF) for Talazoparib
TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method.
Measured: Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)

Secondary outcomes (2)

Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib
rwPFS was defined as the time from initiation of talazoparib to charted disease progression based on radiographic imaging or death from any cause, whichever occurred first. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Since information was retrieved from participants' charts, there was no specific criteria for progression. It was determined on physician judgement. Median was analyzed using the Kaplan-Meier method.
Measured: Index date up to charted disease progression, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)
Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy
The time taken for initiating subsequent chemotherapy after initiation of talazoparib was reported in this outcome measure. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method.
Measured: Index date up to initiation of subsequent chemotherapy, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)

Timeline

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

20 Aug 202111 Oct 2021

First posted3 Aug 2021
Study start20 Aug 2021
Primary completion11 Oct 2021
Study completion11 Oct 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.
Other trials for 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: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04987931
Sponsor's protocol ID: C3441053
Status last verified: Oct 2022
First submitted: 14 Jul 2021
Last updated: 22 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
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.

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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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Talazoparib-Treated Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer and Germline BRCA1/2 Mutations: US Chart Review
ClinicalTrials.gov ID: NCT04987931
Acronym / sponsor ID: C3441053
Conditions: Breast Cancer
Keywords: Talazoparib, Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 Aug 2021 (actual)
Primary completion: 11 Oct 2021 (actual)
Study completion: 11 Oct 2021 (actual)
First posted: 3 Aug 2021 (actual)
Results: Posted 22 Jan 2024

Clinical summary

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

This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US.

The primary population for this study includes:

-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m	–	Drug: TalazoparibHER2-negative ABC patients with gBRCA1/2 mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The primary population for this study includes: -HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Key inclusion criteria (5 listed)

Diagnosed with HER2-negative ABC
gBRCA1/2 mutation(s)
Treatment with talazoparib monotherapy initiated on or after October 16, 2018
-≥18 years of age at initiation of talazoparib
A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period

Key exclusion criteria (4 listed)

Participation in any BC clinical trial after initiation of talazoparib
Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy
gBRCA1/2 or HER2 status unknown
Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection

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
TalazoparibAlso: TALZENNA®This retrospective chart review study focuses on patients with HER2- ABC with gBRCA1/2m initiating talazoparib on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.	Drug	Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m

Primary outcome

Time to Treatment Failure (TTF) for Talazoparib
Time frame: Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)
TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method.

2 secondary outcomes

Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib
Time frame: Index date up to charted disease progression, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)
Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy
Time frame: Index date up to initiation of subsequent chemotherapy, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)

Results and safety

Results posted to the registry on 22 Jan 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
Talazoparib	84	84

Primary outcome: Time to Treatment Failure (TTF) for Talazoparib

Time frame: Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study). Median (95% Confidence Interval). Unit: Months

Measure	Talazoparib n = 52
Value	8.5 (8.0 to 9.7)

Population analysed: Analysis population included all eligible participants with HER2- ABC gBRCA 1/2m who initiated talazoparib on or after 16-October-2018 and were \>=18 years of age at initiation of talazoparib. Here ''Overall Number of Participants Analyzed'' signifies number of participants with TTF event.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality: index date up to death due to any cause, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study); since adverse events (AEs) were not collected hence time frame for AEs not applicable. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Talazoparib	0 of 0	0 of 0	38 of 84

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

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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 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 5 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 22 Jan 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 22 Jan 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?

Time to Treatment Failure (TTF) for Talazoparib (time frame: Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)). 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 NCT04987931.

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 22 Jan 2024.