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Ibrance Real World Insights [IRIS]

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NCT03159195

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Pfizer, Inc.
New York, New York, 10017 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malignant Neoplasm of Breast
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- ≥18 years old

- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.

- Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus
fulvestrant in line with the licenced indication(s)

- No prior or current enrolment in an interventional clinical trial for ABC/MBC

- Minimum of three months of follow up data since palbociclib with fulvestrant
initiation, or minimum of six months of follow up data since palbociclib with
letrozole/aromatase inhibitor initiation (core medical record review)

- Minimum of three months of follow up data since palbociclib initiation (interim
medical record review)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- ≥18 years old

- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.

- Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus
fulvestrant in line with the licenced indication(s)

- No prior or current enrolment in an interventional clinical trial for ABC/MBC

- Minimum of three months of follow up data since palbociclib with fulvestrant
initiation, or minimum of six months of follow up data since palbociclib with
letrozole/aromatase inhibitor initiation (core medical record review)

- Minimum of three months of follow up data since palbociclib initiation (interim
medical record review)

NCT03159195
Pfizer
Recruiting
Ibrance Real World Insights [IRIS]

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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Ibrance Real World Insights [IRIS]
Treatment Patterns And Clinical Outcomes Among Patients Receiving Palbociclib Combinations For Hr+/her2- Advanced/Metastatic Breast Cancer In Real World Settings
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Adult female patients with HR+/HER2 advanced or metastatic breast cancer receiving palbociclib combination regimens as per the approved indication.
Malignant Neoplasm of Breast
Drug: Palbociclib
CDK 4/6 inhibitor for advanced/ metastatic breast cancer
Other Name: Ibrance
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1
September 30, 2019
September 30, 2019   (Final data collection date for primary outcome measure)

INCLUSION CRITERIA

  • ?18 years old
  • HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
  • Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s)
  • No prior or current enrolment in an interventional clinical trial for ABC/MBC
  • Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review)
  • Minimum of three months of follow up data since palbociclib initiation (interim medical record review)
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female participants only
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03159195
A5481090
No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now