An open-label, multi-center, sINGlE arm clinical study to evaluate treatment efficacy and quality of life in women with hormone-receptor-positive, HER2-negative loco-regionally recurrent or metastatic breast cancer receiving palbociclib (PD 0332991) in combination with an aromatase inhibitor, or fulvestrant after prior endocrine therapy (INGE-B) - INGE-B

iOMEDICO AG0 个研究点目标入组 360 人开始时间: 2016年2月4日最近更新: 2021年8月2日

适应症

试验速览

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•- Patients with proven diagnosis of advanced adenocarcinoma of the breast (locally advanced, inoperable or metastatic disease).
•- Patients with hormone-receptor-positive (HR+) disease, defined as ER+ and/or PgR+
•- Patients with human-epidermal-growth-factor-receptor-2-negative (HER2-) disease
•- Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist or postmenopausal status
•- Patients scheduled for palliative treatment with the combination of palbociclib and letrozole for first- or later-line, anastrozole for first-line, exemestane for first-line, or fulvestrant for first-or later-line after prior endocrine failure.
•- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•- Patient has received prior treatment with any CDK inhibitor
•- Prior adjuvant therapy with the respective endocrine combination partner if last intake <12 months prior to entering the study
•- Prior palliative therapy with the respective endocrine combination partner
•- More than one palliative chemotherapy for patients in treatment group 5 (second or later line, Palbociclib and Letrozole) and group 6 (Second or leter line, Palbociclib and Fulvestrant after prior endocrine therapy)
•- Patient has known, not-irradiated CNS metastases

发起方