Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obtained from structured data fields within an electronic health record (EHR) database and will be supplemented by additional unstructured data collected through a targeted chart review.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib + aromatase inhibitor | Palbociclib + aromatase inhibitor |
| |
| Aromatase inhibitor alone | Aromatase inhibitor alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib + aromatase inhibitor | Drug | Palbociclib + aromatase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real World Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW]) | rwTR of complete response (CR) or partial response (PR) based on response assessments captured with chart review during first line therapy. Real-world response rate (rwRR) was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases. | 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020. |
| Real World Tumor Response in Patients With Tumor Assessment (Adjusted by nIPTW) | rwTR of complete CR or PR based on response assessments captured with chart review during first line therapy. rwRR was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases. | 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020. |
Not provided
Not provided
Inclusion Criteria:
Pre or perimenopausal at MBC diagnosis
Diagnosis of MBC in patient history
Confirmed HR+/HER2- status as defined as: a. HR+: ER+ or PR+ test; b. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, fluorescence in situ hybridization [FISH] positive/amplified, positive not otherwise specified [NOS]).
Received one of the following regimens as first-line treatment for MBC during the period from 01 January 2010 through index period 30 June 2020 until the data cutoff date of 31 December 2020.
Received care at a US Oncology Network (USON) site(s) utilizing the full EHR capacities of iKnowMed (iKM) at the time of treatment.
EHR data available from the USON site(s) where the patient received treatment are accessible for research purposes.
Exclusion Criteria:
pre-menopausal metastatic breast cancer patients
Not provided
pre-menopausal metastatic breast cancer patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer New York | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37428347 | Derived | DeMichele A, Robert N, Chen C, Kim S, Zhang Z, Lu DR, Aguilar KM, Wang Y, Li B, Schneeweiss S, Rassen JA, Gaffney M, McRoy L. Real-World Tumor Response of Palbociclib in Combination With an Aromatase Inhibitor as First-Line Therapy in Pre/Perimenopausal Women With Metastatic Breast Cancer. Target Oncol. 2023 Jul;18(4):543-558. doi: 10.1007/s11523-023-00979-1. Epub 2023 Jul 10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
A total of 196 patients were included in the study, with 116 patients in the palbociclib plus AI cohort and 80 patients in the AI monotherapy cohort, after applying inclusion and exclusion criteria, using EHR structured data and chart review to confirm eligibility.
Data from United States Oncology Network's (USON) iKnowMed (iKM) electronic health record (EHR) database combined with chart review in pre/perimenopausal patients with hormone receptor (HR) positive, human epidermal growth factor receptor (HER2) negative metastatic breast cancer (MBC) who initiated palbociclib plus aromatase inhibitor (AI) or AI alone as first-line therapy during the period of from 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib + AI | Pre/perimenopausal patients, diagnosed with HR positive (+), HER2 negative (-) MBC who initiated palbociclib along with AI as first-line therapy on or after 01 January 2010 up to and including 30 June 2020 |
| FG001 | AI Monotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2020 | Nov 22, 2022 |
Not provided
Not provided
Not provided
Not provided
| Aromatase inhibitor | Drug | Aromatase inhibitor |
|
Pre/perimenopausal patients, diagnosed with HR+, HER2- MBC who initiated AI alone as first-line therapy on or after 01 January 2010 up to and including 30 June 2020 |
| Discontinued | Included first line metastatic treatment only |
|
| Ongoing | Included first line metastatic treatment only |
|
| COMPLETED | Included first line metastatic treatment only |
|
| NOT COMPLETED |
|
Analysis population included all eligible participants whose data were retrieved and observed in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib + AI (All Patients) | Patients who received palbociclib along with AI on or after 01 January 2010 up to and including 30 June 2020 for the treatment of MBC as part of their routine treatment were observed retrospectively. |
| BG001 | AI Monotherapy (All Patients) | Patients who received AI alone on or after 01 January 2010 up to and including 30 June 2020 for the treatment of MBC as part of their routine treatment were observed retrospectively. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) (>= 25) | Count of Participants | Participants |
| ||||||||||||||||||
| Disease Site (s) | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Metastatic Site(s) | Count of Participants | Participants |
| ||||||||||||||||||
| Stage at Diagnosis | Stage refers to the extent of your cancer, such as how large the tumor is and if it has spread. Stage is determined by X-rays, lab tests and other tests or procedures. Tumor, Node, Metastasis (TNM) combinations were used. TNM combinations were grouped into 5 stages: Stage 0 = abnormal cells were present but had not spread to nearby tissue; Stage I, Stage II and Stage III = Cancer was present. The higher the number, the larger the cancer tumor and the more it had spread into nearby tissues; Stage IV = The cancer has spread to distant parts of the body. | Count of Participants | Participants |
| |||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status score is a rating of a patient's disease status, daily living activities and quality of life, with low scores indicating greater functioning than high scores: 0 = fully active; 1 = restricted in physically strenuous; 2 = ambulatory and capable of self-care but unable to work; 3 = capable of self-care but unable to work; 4 = completely disabled; 5 = dead. 2+ included those participants with ECOG performance status scores of 2-5. | Count of Participants | Participants |
| |||||||||||||||||
| Prior Neo/Adjuvant Chemotherapy | Count of Participants | Participants |
| ||||||||||||||||||
| Disease-free Interval | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Real World Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW]) | rwTR of complete response (CR) or partial response (PR) based on response assessments captured with chart review during first line therapy. Real-world response rate (rwRR) was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases. | Pre/perimenopausal patients who were treated with palbociclib plus AI or AI monotherapy as first-line treatment for HR positive, HER2 negative MBC in the US clinical practice setting from the USON database who met the inclusion/exclusion criteria of the study protocol. The study period began at patients' starting date of the first-line MBC treatment during the period of 01 January 2010 through 30 June 2020 to study end (data cutoff 31 December 2020). | Posted | Number | Percentage of Participants | 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Real World Tumor Response in Patients With Tumor Assessment (Adjusted by nIPTW) | rwTR of complete CR or PR based on response assessments captured with chart review during first line therapy. rwRR was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease (decrease in disease volume even though disease is still present). nIPTW method was employed to reduce confounding due to potential selection biases. | A subgroup of patients with at least 1 tumor assessment on treatment, from pre/perimenopausal patients treated with palbociclib plus AI or AI monotherapy as first-line treatment for HR positive, HER2 negative MBC in the US clinical practice setting from the USON database who met the eligibility of the study protocol. Began at patients' starting date of the first-line MBC treatment from 01 January 2010 to 30 June 2020 to study end (data cutoff 31 December 2020). | Posted | Number | Percentage of Participants | 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020. |
|
11 Years.
Due to non-interventional nature of the study, safety data was collected as standard non-interventional study reporting only, with the exception of for ILD and pneumonitis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palbociclib + AI | Patients who received palbociclib along with AI on or after 01 January 2010 up to and including 30 June 2020 for the treatment of MBC as part of their routine treatment were observed retrospectively. Normalized inverse probability of treatment weighting (nIPTW) adjustment was applied. | 27 | 116 | 0 | 116 | 0 | 116 |
| EG001 | AI Monotherapy | Patients who received AI alone on or after 01 January 2010 up to and including 30 June 2020 for the treatment of MBC as part of their routine treatment were observed retrospectively. Normalized inverse probability of treatment weighting (nIPTW) adjustment was applied. | 38 | 80 | 0 | 80 | 0 | 80 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2021 | Nov 22, 2022 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
| >=45 Years |
|
| Male |
|
| White |
|
| Not Reported |
|
| Unknown |
|
| No |
|
| Unknown |
|
| Non-visceral |
|
| Bone Only |
|
| 2 |
|
| 3+ |
|
| Stage I |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Unknown |
|
| 1 |
|
| 2+ |
|
| Unknown |
|
| No |
|
| >= 12 Months |
|
| De Novo Metastatic |
|
| Unknown |
|
| OG001 | AI Monotherapy | Patients who received AI alone on or after 01 January 2010 up to and including 30 June 2020 for the treatment of MBC as part of their routine treatment were observed retrospectively. Normalized inverse probability of treatment weighting (nIPTW) adjustment was applied. |
|
|
|