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Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region

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ClinicalTrials.gov Identifier: NCT04916509
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2- metastatic/locally advanced breast cancer (BC)

Condition or disease Intervention/treatment
Breast Neoplasms Drug: Palbociclib plus an aromatase inhibitor Drug: Palbociclib plus fulvestrant

Study Design
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Study Type : Observational
Estimated Enrollment : 665 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region Like Saudi Arabia, UAE and Other GCC Countries: A Retrospective Study (Treasure Study)
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Palbociclib plus an aromatase inhibitor

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor.

Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.

Aligned with Locally Approved Indication

 Drug: Palbociclib plus an aromatase inhibitor
Palbociclib plus an aromatase inhibitor therapy
palbociclib plus fulvestrant

Adult metastatic breast cancer patients who initiated Palbociclib + fulvestrant. Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.

Aligned with Locally Approved Indication

 Drug: Palbociclib plus fulvestrant
Palbociclib plus fulvestrant


Outcome Measures
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Primary Outcome Measures :
  1. Demographical Characteristics of Participants [ Time Frame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019) ]
  2. Demographical Characteristics of Participants: Biomarker status [ Time Frame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019) ]
    Biomarker status - (estrogen receptor [ER], progesterone receptor [PR], HER-2 neu, Ki67, Germline BRCA [gBRCA] testing).

  3. Clinical Characteristics of Participants: Description of diagnosis [ Time Frame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019) ]
    Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.

  4. Number of patients receiving adjuvant therapies [ Time Frame: Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019) ]
    Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)

  5. Number of participants receiving treatment for advanced/metastatic BC before and after palbociclib combination use [ Time Frame: Upon diagnosis of metastatic/locally advanced HR+/HER2 BC for a maximum of 4 years approximately (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019) ]
    Treatments and supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis. Duration of treatments. Reasons for regimen changes. Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible reasons for change in treatment. Line of treatment.

  6. Number of participants with dose changes associated with palbociclib use [ Time Frame: From 01 January 2015 to 30 September 2019 ]
    Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.

  7. Number of participants to discontinue treatment associated with palbociclib use [ Time Frame: From 01 January 2015 to 30 September 2019 ]
    Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.

  8. Number of participant receiving supportive therapies while receiving palbociclib combination treatment [ Time Frame: From 01 January 2015 to 30 September 2019 ]
    Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.

  9. Proportion of patients who are progression free at multiple intervals [ Time Frame: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 57 months ]
    Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 months).

  10. Objective response rate (ORR) [ Time Frame: From date of index treatment up to 57 months ]
    Proportion of objective response rate (at intervals per standard of care).

  11. Proportion of patients alive 1 and 2 years post palbociclib combination initiation depending on availability of follow-up data (if available) [ Time Frame: From 01 January 2015 to 30 September 2019 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Data will be abstracted from the medical records of all eligible patients across 17 - 35 selected sites from Arabian Gulf Region countries. The observational period for patients is the 57 month-period prior to the study index date. During this period, patients who initiated treatment with palbociclib between 01st January 2015 and 01st March 2019 will be considered eligible for participation in the study. Sites from diverse health care settings
Criteria

Inclusion Criteria:

  1. Age ≥18 years old.
  2. HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease.
  3. Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March 2019.
  4. Minimum of six months of follow up data since palbociclib initiation.
  5. Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s).

Exclusion Criteria:

  1. Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
  2. Patients who were initiated on palbociclib after 01st March 2019.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916509


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Meteb Al-Foheidi King Abdul-Aziz Medical City, National Guard Hospital
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04916509    
Other Study ID Numbers: A5481136
TREASURE ( Other Identifier: Alias Study Number )
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Keywords provided by Pfizer:
Retrospective Studies
palbociclib
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Palbociclib
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors