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

Primary outcomes

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