A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.

NCT05770713 | Completed Results

• 1 other identifier: A5481178
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies. The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC). Female patients aged 18 years old or more presenting the following conditions will be selected for the study:

• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
• Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021
• Treatment with CDK4/6 inhibitor Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.

Conditions

Breast Cancer

Keywords

metastatic breast cancer; advanced breast cancer; HR+/HER2-

Outcome Measures

Primary Outcomes (1)

• Number of Participants Classified According to Treatment Pattern

  Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel.

  From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study

Secondary Outcomes (2)

• Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor

  From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study

• Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor

  From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study

Study Arms (1)

Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC.

Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed with HR+/HER2- ABC/MBC who received a CDK4/6 inhibitor at Sinai Health, Canada during the study period.

You may qualify if:

• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
• Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021
• Treatment with CDK4/6 inhibitor

You may not qualify if:

• Patient does not have ABC/MBC
• Patient has indicated HR- or HER2+ status
• Patient received a CDK4/6i as part of a clinical trial

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Canada

Kirkland, Quebec, H9J2M5, Canada

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 15, 2023
• Study Start: October 12, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)