Breast cancer drug combo safety study ends early – only 4 patients enrolled
NCT ID NCT04967248
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This was an observational study that planned to track side effects, especially high blood sugar, in patients taking alpelisib (Piqray) plus fulvestrant for a type of advanced breast cancer. It included postmenopausal women and men whose cancer had a specific gene mutation (PIK3CA) and had worsened after hormone therapy alone. However, the study was terminated early after enrolling only 4 participants, so it provides very limited information.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alpelisib (Piqray) and fulvestrant
- What this could lead to
- If successful, this study could provide real-world safety data on alpelisib combined with fulvestrant for advanced breast cancer patients.
- What could go wrong
- The study was terminated early with only 4 participants, so results are very limited and may not be reliable or generalizable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
4 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
-
Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who were treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken * Patients diagnosed with HR+, HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation * Patients who have disease progression following endocrine therapy as monotherapy * Patients must be postmenopausal women, or men, ≥18 years of age * Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant Exclusion Criteria: * Use of alpelisib prior to signing the informed consent form for this study * Participation in an interventional study within 30 days prior to the initiation of alpelisib
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.