Clinical Trials

JBCRG-C06

Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer

Status
No Longer Recruiting

Objectives
The purpose of this study is to retrospectively evaluate effects of subject's clinical background and prior therapies on the treatment time with Fulvestrant(TTF), in patients with postmenopousal ER-positive advanced recurrent breast cancer receiving Fulvestrant in clinical setting in Japan. Also this study is to explore the impact on prognosis for advanced recurrent breast cancer receiving Fulvestrant as a secondary analysis.

Subjects

Endpoints
Primary: Effects of clinical background and prior therapies on the treatment time with Fulvestrant (TTF) secondary: Secondary analysis 1.Effects of clinical background and prior therapies on overall survival (OS) after start of Fulvestrant 2.Descriptive statistics of treatment 3.Summary of therapies administered to subjects with long survival

Trial Period

Lead Principal Investigator
Hidetoshi Kawaguchi Matsuyama Red Cross Hospital Shinji Ohno National Hospital Organization Kyushu Cancer Center

Target Sample Size
1000

Regimen
Fulvestrant

Source of Funding
AstraZeneca K.K.

Conference Presentation
Retrospective study using database for the effectiveness of medroxyprogesterone acetate in patients with ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study Outcomes of fulvestrant therapy among Japanese women with ER-positive HER2-positive advanced or metastatic breast cancer: A subgroup analysis of the Japan Breast Cancer Research Group(JBCRG)-C06 Safari study Factors associated with prolonged post-recurrence survival in patients with postmenopausal estrogen receptor-positive breast cancer taking fulvestrant: A follow-up data of the JBCRG-C06 Safari study Influence of the adjuvant hormonal therapy on hormone sensitivity and survival outcomes in ER+ and HER2−advanced breast cancer: a subgroup analysis of the JBCRG-C06 Safari study Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with postmenopausal estrogen receptor-positive advanced/metastatic breast cancer: A subgroup analysis (JBCRG-C06) Search for appropriate treatment strategy using fulvestrant for postmenopausal ER-positive advanced or recurrent breast cancer patients in Japan (JBCRG-C06; Safari)

Articles and Publications
Fulvestrant with or without anti-HER2 therapy in patients in a postmenopausal hormonal state and with ER-positive HER2-positive advanced or metastatic breast cancer: a subgroup analysis of data from the Safari study (JBCRG-C06) Retrospective study on the effectiveness of medroxyprogesterone acetate in the treatment of ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study Factors associated with overall survival after recurrence in patients with ER-positive/HER2-negative breast cancer: An ad-hoc analysis of the JBCRG-C06 Safari study Factors associated with prolonged overall survival in patients with postmenopausal estrogen receptor-positive advanced breast cancer using real-world data: a follow-up analysis of the JBCRG-C06 Safari study Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with post-menopausal estrogen receptor-positive advanced breast cancer: a sub-group analysis of the JBCRG-C06 Safari study. Effectiveness of Fulvestrant in Advanced or Metastatic Breast Cancer Patients in the Real World: A Retrospective Multi-center Cohort Study with 1072 Patients (JBCRG-C06; Safari)

UMIN-ID
UMIN000015168

jRCT

Memo

COI Disclosure

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