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

Breast Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916509
• Other study ID #: A5481136
• Secondary ID: TREASURE
• Status: Completed
• Start date: September 13, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha
Saudi Arabia	King Abdulaziz Medical City National Guard Hospital	Jeddah
Saudi Arabia	King Abdulaziz Medical City National Guard Hospital Riyahd	Riyadh
Saudi Arabia	King Saud University Medical City Riyadh PO BOX 7805	Riyadh
United Arab Emirates	Tawam	Al Ain
United Arab Emirates	Dubai Hospital	Dubai
United Arab Emirates	Mediclinic City Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Qatar,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographical Characteristics of Participants		Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Primary	Demographical Characteristics of Participants: Biomarker status	Biomarker status - (estrogen receptor [ER], progesterone receptor [PR], HER-2 neu, Ki67, Germline BRCA [gBRCA] testing).	Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Primary	Clinical Characteristics of Participants: Description of diagnosis	Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.	Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Primary	Number of patients receiving adjuvant therapies	Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)	Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Primary	Number of participants receiving treatment for advanced/metastatic BC before and after palbociclib combination use	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.	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)
Primary	Number of participants with dose changes associated with palbociclib use	Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.	From 01 January 2015 to 30 September 2019
Primary	Number of participants to discontinue treatment associated with palbociclib use	Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.	From 01 January 2015 to 30 September 2019
Primary	Number of participant receiving supportive therapies while receiving palbociclib combination treatment	Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.	From 01 January 2015 to 30 September 2019
Primary	Proportion of patients who are progression free at multiple intervals	Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 months).	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
Primary	Objective response rate (ORR)	Proportion of objective response rate (at intervals per standard of care).	From date of index treatment up to 57 months
Primary	Proportion of patients alive 1 and 2 years post palbociclib combination initiation depending on availability of follow-up data (if available)		From 01 January 2015 to 30 September 2019

External Links

•   To obtain contact information for a study center near you, click here.