Status:
ACTIVE_NOT_RECRUITING
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
Lead Sponsor:
Borstkanker Onderzoek Groep
Collaborating Sponsors:
Novartis Pharma B.V.
BOOG Study Center
Conditions:
Neoplasm, Breast
Congenital, Familial and Genetic Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulve...
Eligibility Criteria
Inclusion
- Adult women and men (≥ 18 years of age) with proven diagnosis of adenocarcino-ma of the breast withlocoregional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent andfor whom chemotherapy is not clinically indicated
- Estrogen receptor (ER) expression \>10% and/or progesterone receptor (PR) expression \>10% breast cancerbased 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
- Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in theshort term
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningealdisease as indicated by clinical symptoms, cerebral edema, and/or progressive growth
- Prior treatment with a PI3K /AKT/mTOR inhibitor
- Type 1 diabetes or uncontrolled type 2 diabetes (Hba1C \> 68 mmol/mol)
- Clinically significant, uncontrolled heart disease and/or recent cardiac events
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05392608
Start Date
June 2 2022
End Date
March 1 2028
Last Update
September 17 2025
Active Locations (25)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
3
Ziekenhuisgroep Twente
Almelo, Netherlands
4
Meander Medisch Centrum
Amersfoort, Netherlands