SEQUence of Endocrine therapy in advanced Luminal Breast cancer (SEQUEL-Breast): A phase 2 study on fulvestrant beyond progression in combination with alpelisib for PIK3CA-mutated, hormone-receptor positive HER2 negative advanced breast cancer - SEQUEL-Breast

BOOG Study Center0 个研究点目标入组 130 人开始时间: 2022年3月18日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•1. Adult women and men (= 18 years of age) with proven diagnosis of adenocarcinoma of the breast with locoregional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
•2. Estrogen receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer.
•3. Patients must have progressed on fulvestrant as a preceding treatment line (as first or second line therapy).
•4. Previous treatment with a CDK4/6 inhibitor in the advanced setting.
•5. The presence of an activating PIK3CA mutation.
•6. Evaluable disease as defined per RECIST v.1.1.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term (visceral crisis).
•2. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progres-sive growth.
•3. Prior treatment with a PI3K /AKT/mTOR inhibitor.
•4. Type 1 diabetes or uncontrolled type 2 diabetes (Hba1C at screening exceeds 68 mmol/mol).
•5. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection.
•6. Clinically significant, uncontrolled heart disease and/or recent cardiac events.

发起方

BOOG Study Center