Clinical trial NCT04735367: Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
Official title: Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: retrospective
multicenter
observational study
Japan
HR+/HER2- advanced breast cancer
palbociclib
overall survival
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated, treated with palbociclib plus letrozole, and under follow-up for survival in J-Ph2

Brief summary: This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus letrozole. This observational study was planned as follow-up study of Japanese phase 2 study of palbociclib (NCT01684215, phase 2 portion of A5481010 study).


Eligibility criteria: Inclusion Criteria:

1. Participated, treated with palbociclib plus letrozole in J-Ph2, and was under follow-up for survival at the study completion of J-Ph2.
2. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained. For patients who had already passed away, the conduct of this study will be disclosed, and the patients' legally acceptable representatives will be guaranteed an opportunity to refuse data collection for the patients in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects

Exclusion Criteria:

1. There are no exclusion criteria for this study.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Date of first treatment dose until death or end of study collection on 31 Dec 2022, whichever is later.
Secondary outcomes:
measure: Type of subsequent therapy after palbociclib plus letrozole
timeFrame: Date of first treatment dose until death or end of study collection on 31 Dec 2024
measure: Duration of subsequent therapy after palbociclib plus letrozole
timeFrame: Date of first treatment dose until death or end of study collection on 31 Dec 2024
Other outcomes:
Locations:
city: Chiba-shi
country: Japan
facility: Chiba cancer center
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Hiroshima-city
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kumamoto-city
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Kita-adachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kagoshima
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: