Breast Neoplasms
Conditions
Keywords
Retrospective Studies, palbociclib
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)
Interventions
DRUGPalbociclib plus an aromatase inhibitor
Palbociclib plus an aromatase inhibitor therapy
Palbociclib plus fulvestrant
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Clinical Characteristics of Participants: Description of diagnosis | 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. |
| Number of patients receiving adjuvant therapies | 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) |
| Number of participants receiving treatment for advanced/metastatic BC before and after palbociclib combination use | 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. |
| Number of participants with dose changes associated with palbociclib use | 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. |
| Number of participants to discontinue treatment associated with palbociclib use | 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. |
| Number of participant receiving supportive therapies while receiving palbociclib combination treatment | 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. |
| Proportion of patients who are progression free at multiple intervals | 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). |
| Objective response rate (ORR) | From date of index treatment up to 57 months | Proportion of objective response rate (at intervals per standard of care). |
| 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 | — |
Countries
Qatar, Saudi Arabia, United Arab Emirates
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed