Clinical trial · Interventional
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alpelisib | Drug | Alpelisib | ALIAS |
| buparlisib | Drug | Buparlisib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Alpelisib + Letrozole
- description
- Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
- interventionNames
- Drug: alpelisib
- type
- EXPERIMENTAL
- label
- Buparlisib + Letrozole
- description
- Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
- interventionNames
- Drug: buparlisib
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Letrozole
- description
- Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is an adult, female ≥ 18 years old at the time of informed consent 2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer 3. Patient is postmenopausal. 4. Patient has T1c-T3, any N, M0, operable breast cancer 5. Patients must have measurable disease 6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level. 7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing 8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing Exclusion Criteria: 1. Patient has locally recurrent or metastatic disease 2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization. 3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus 4. History of acute pancreatitis within 1 year of study entry 5. Uncontrolled hypertension
References
Publications (1)
- DERIVEDMayer IA, Prat A, Egle D, Blau S, Fidalgo JAP, Gnant M, Fasching PA, Colleoni M, Wolff AC, Winer EP, Singer CF, Hurvitz S, Estevez LG, van Dam PA, Kummel S, Mundhenke C, Holmes F, Babbar N, Charbonnier L, Diaz-Padilla I, Vogl FD, Sellami D, Arteaga CL. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB). Clin Cancer Res. 2019 May 15;25(10):2975-2987. doi: 10.1158/1078-0432.CCR-18-3160. Epub 2019 Feb 5. PMID 30723140