A Phase 2 interventional study of Alpelisib 150 MG Oral Tablet [Piqray] and Fulvestrant in Neoplasm, Breast and Congenital, Familial and Genetic Disorders, sponsored by Borstkanker Onderzoek Groep. Active, not recruiting at 25 sites in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Borstkanker Onderzoek Groep · Phase 2, Interventional, and Treatment
Among 38 studies testing alpelisib in Breast Neoplasms — 3 open to participants now, 12 under way, 2 of them phase 3. Alpelisib · Breast Neoplasms.
Among the 38 studies testing alpelisib in Breast Neoplasms, this one is the 8th largest by planned enrollment, is one of 4 that started in 2022, is one of 15 in phase 2, reaches primary completion later than 3 of the 11 other live ones, and was the 33rd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →3 of the 38 studies testing alpelisib in Breast Neoplasms are open now, in 1 country. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
The Methodist Hospital Research Institute · Sites in United States
Novartis Pharmaceuticals
By country, each count listing its studies:
Alpelisib: first FDA approval 2019 (PIQRAY), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, alpelisib is the treatment under test here. Read study by study →
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 19 · Phase 3 5
First in 2010; this study’s year is marked. 4 started in 2022.
This study's planned enrollment of 130 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 44 across the 38 interventional studies. Of the 25 that completed or were terminated, 10 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 38 have an industry lead sponsor. The 10 most frequent:
Borstkanker Onderzoek Groep is the lead sponsor of 8 studies on the registry; none are open to participants now.
Borstkanker Onderzoek Groep has 8 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
7 of the studies testing alpelisib in Breast Neoplasms that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04208178Phase 3Novartis PharmaceuticalsStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | 2027-02-26 |
| NCT05660083The Methodist Hospital Research InstituteAlpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) | 2026-12-01 |
| NCT04544189Novartis PharmaceuticalsStudy Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer | 2027-01-29 |
| NCT01872260Novartis PharmaceuticalsStudy of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer | 2027-02-26 |
Among the 38 studies testing alpelisib in Breast Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alpelisib plus fulvestrant beyond progression
Drug: Alpelisib 150 MG Oral Tablet [Piqray] · Drug: Fulvestrant
Alpelisib 300mg once daily (may be reduced to 1dd250 or 1dd200mg in case of toxicity)
Also known as: Piqray
Fulvestrant 300mg 1x/four weeks
Also known as: Faslodex
Progression-free survival (PFS)
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.
Time frame: From registration to progression, assessed up to 36 months
'On treatment' Progression-free survival (PFS)
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
Time frame: From registration to progression, assessed up to 36 months
Objective Response Rate
Described as complete response (CR) or partial response (PR)
Time frame: From registration to progression, assessed up to 36 months
Clinical Benefit Rate
Described as stable disease (SD), PR, or CR
Time frame: From registration to progression, assessed up to 36 months
Duration of Response (DoR)
Duration of Response
Time frame: From registration to progression, assessed up to 36 months
Determine circulating tumor DNA (ctDNA) in plasma before and during treatment
Exploratory endpoint; determine circulating tumor DNA (ctDNA) in plasma before and during treatment, to investigate the prognostic and possibly predictive values of these measures
Time frame: At baseline, 2 weeks of treatment, 8 weeks of treatment and every 8 weeks until disease progression. Assessed up to 36 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in May 2026, 47 months.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's 47 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Alpelisib · Fulvestrant
Borstkanker Onderzoek Groep