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.

Phase 2

Recruiting

Conditions: Breast cancer
HR positive/HER2 negative breast cancer
10006291

Registration Number: NL-OMON54330

Lead Sponsor: BOOG Study Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

* Adult women and men (>= 18 years of age) with proven diagnosis of
adenocarcino-ma 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
* Estrogen receptor (ER) expression >10% and/or progesterone receptor (PR)
expression >10% breast cancer based on local la-boratory results. Tumor must be
HER2- as defined by ASCO-CAP guidelines
* Patients must have progressed on fulvestrant as a preceding treatment line
(as first or second line therapy)
* Previous treatment with a CDK4/6 inhibitor in the advanced setting
* The presence of an activating PIK3CA mutation
* Evaluable disease* as defined per RECIST v.1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Exclusion Criteria

* Patients with advanced, symptomatic, visceral spread, who are at risk of
life-threatening complications in the short term
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous
meningitis, or leptomeningeal disease as indicated by clinical symptoms,
cerebral edema, and/or progressive growth
* Prior treatment with an PI3K /AKT/mTOR inhibitor
* Prior treatment with chemotherapy in the advanced setting
* (prior) use of oral SERD in any setting
* Type 1 diabetes or uncontrolled type 2 diabetes (Hba1C > 68 mmol/mol)
* Clinically significant, uncontrolled heart disease and/or recent cardiac
events

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- to determine Progression-free survival (PFS), defined as time from study<br /><br>enrollment to disease progression or death from any cause, with censoring when<br /><br>fulvestrant and alpelisib are stopped and another treatment is initiated<br /><br>without confirmed disease progression.</p><br>

Secondary Outcome Measures