Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Patients Treated with Palbociclib for Advanced Breast Cancer in Australia (PIPPA)

Not Applicable

• Conditions: Advanced Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12622001004752
• Lead Sponsor: Pfizer Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-18
• Study Completion: 2023-05-10
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.Has regular access to the ClaimIt virtual trial platform application via Apple iPhone (compatible with operating system versions 13, 12 and 11) or Android phone (compatible with versions 10, 9, 8) and is willing and able to complete data entry through application
2.Adult women or men (greater or equal to 18 years of age) with diagnosis with advanced or metastatic breast cancer not amenable to resection or radiation therapy with curative intent
3.Evidence of HR+ tumor based on the patient’s most recent tumor biopsy as reported by site-based HCP or self-reported by patient
4.Evidence of an HER2– tumor based on the patient’s most recent tumor biopsy as reported by site-based HCP or self-reported by patient
5.Recently intiated on first or second line treatment with one of the following regimens: (i) palbociclib and an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with advanced or metastatic disease as per product label or (ii) palbociclib with fulvestrant if the patient has experienced disease progression following endocrine therapy as per product label, where recently initiaited is defined as within the last seven days for the site based cohort and last 90 days for the virtual cohort
6.Evidence of an electronically signed and dated informed consent form indicating that the patient has been informed of all pertinent aspects of the study
7.Able to read and understand English

Exclusion Criteria

1.Patient has initiated palbociclib more than seven days prior to study or enrolment (site-based cohort)
2.Patient has initiated palbociclib more than 90 days prior to study enrolment (virtual cohort)
3.Patient is initiating adjuvant or neoadjuvant systemic therapy
4.The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study
5.The patient is on active treatment for other malignancies other than Advanced Breast Cancer (ABC) or metastatic breast cancer (mBC)
6.In the judgment of the investigator, the patient’s life expectancy is fewer than 180 days (i.e. six months) at the time of diagnosis of ABC or mBC (site-based cohort)

Study & Design

• Study Type: Interventional
• Study Design: Not specified