Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Disease Progression

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Alpelisib plus fulvestrant beyond progression

Alpelisib 300mg once daily (may be reduced to 1dd250 or 1dd200mg in case of toxicity)

Alpelisib 150 MG Oral Tablet [Piqray]

Annemarie C.A.M. Almekinders, MD

S. Vrijaldenhoven

E Siemerink

J Baas

A van Zweeden

I. Konings

V Dezentjé

S Hiddink

K Beelen

J Heijns

L Mammatas

J Tol

D. Houtsma

L Kessels

M Dercksen

M. Pleunis-van Empel

E van Vliet

A van der Velden

A Beeker

L. Hamming

P. de Jong

C. Mandigers

A. van der Padt-Pruijsten

H Zuetenhorst

J.M.G.H. van Riel

A van de Wouw

Vincent V.O. Dezentjé, MD PhD

Inge I.R. Konings, MD PhD

Monique M.E.M.M. Bos, MD PhD

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 fulvestrant (either in first or second line, with or without previous use of CDK4/6-inhibitor) in patients with HR+ HER2- advanced breast cancer with PIK3CA mutated tumors.

All eligible patients must have progressive disease on fulvestrant as latest treatment line.

Previous treatment with a CDK4/6 inhibitor in first or second line is obligatory. After progressive disease is confirmed, it is important to continue fulvestrant (without CDK4/6 inhibition) during the screening period awaiting study enrollment.

After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression. Follow-up time will be until progression or death or until a different oncolytic treatment has started (in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented).

Should participants discontinue due to reasons other than progression or death (e.g. toxicity), then they should still be evaluated for disease progression every 8 weeks as per protocol until progression, unless they do not wish to proceed with these screenings, or receive a different oncolytic treatment.

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

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

Exploratory endpoint; determine circulating tumor DNA (ctDNA) in plasma before and during treatment, to investigate the prognostic and possibly predictive values of these measures

Defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped and another treatment is initiated without confirmed disease progression.

Defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped earlier than disease progression

Spots Global Cancer Trial Database for alpelisib 150 mg oral tablet [piqray]