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| ID | Type | Description | Link |
|---|---|---|---|
| TREASURE | Other Identifier | Alias Study Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib plus an aromatase inhibitor | Drug | Palbociclib plus an aromatase inhibitor therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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) |
| 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) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | Qatar | ||||
| King Abdulaziz Medical City National Guard Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| Palbociclib plus fulvestrant | Drug | Palbociclib plus fulvestrant |
|
| 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 |
| 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 |
| 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 |
| 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 |
| Objective response rate (ORR) | Proportion of objective response rate (at intervals per standard of care). | From date of index treatment up to 57 months |
| 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 |
| Jeddah |
| 22384 |
| Saudi Arabia |
| King Abdulaziz Medical City National Guard Hospital Riyahd | Riyadh | 11426 | Saudi Arabia |
| King Saud University Medical City Riyadh PO BOX 7805 | Riyadh | 11472 | Saudi Arabia |
| Tawam | Al Ain City | United Arab Emirates |
| Dubai Hospital | Dubai | United Arab Emirates |
| Mediclinic City Hospital | Dubai | United Arab Emirates |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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