RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.

Breast Cancer Clinical Trial

Official title:

Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460898
• Other study ID #: A5481123
• Status: Completed
• Start date: January 4, 2019
• Est. completion date: June 24, 2019

Study information

• Verified date: April 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Diagnosed with locoregional recurrent or metastatic female breast cancer.

2. Pathologically confirmed HR-positive/HER2-negative diagnosis.

3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.

2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.

4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.

5. =18 year old at initiation of palbociclib.

Exclusion Criteria:

• No exclusion criteria will be imposed for the selection of patients.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Pfizer United States	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		mBC diagnosis through end of study (assessed up to 24 months)
Primary	Tumor response		mBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients receiving various cancer treatment regimens		mBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients receiving each therapy sequence across lines		mBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients receiving each starting dose and end dose for those on palbociclib combination therapy		mBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients that experienced dose adjustment		mBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients that discontinued therapy		mBC diagnosis through end of study (assessed up to 24 months)

External Links

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