Clinical trial · Interventional
BKM120 For Triple Negative Breast Cancer
A Phase II Trial of BKM120 in Patients With Triple Negative Metastatic 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)
Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Limited treatment options exist in the clinic as hormonal therapies and HER2-trageted agents have proven ineffective. BKM120 is a drug that works by blocking a protein called phosphatidylinositol-3-kinase (PI3K) which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing. In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BKM120 | Drug | Buparlisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BKM120
- description
- BKM120: 100 mg capsule once daily each day of a 28 day cycle . Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons.
- interventionNames
- Drug: BKM120
Primary outcomes (1)
- measure
- Clinical Benefit Rate
- timeFrame
- Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.
- description
- Clinical benefit rate (CBR) was defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically and radiologically confirmed metastatic triple negative breast cancer * Up to two prior lines of chemotherapy for metastatic breast cancer * Availability of a representative tumor specimen * At least one measurable lesion Exclusion Criteria: * Have received previous treatment with PI3K inhibitors * Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS metastases are acceptable) * Concurrent malignancy or has a malignancy within 3 years of study enrollment * Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 anxiety * Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study * Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy * Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery * Poorly controlled diabetes mellitus * History of cardiac dysfunction * Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 * Receiving chronic treatment with steroids or another immunosuppressive agent * Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study * History of non-compliance to a medical regimen * Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A) * Known history of human immunodeficiency virus (HIV) * Pregnant or breastfeeding * Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial
References
Publications (1)
- DERIVEDGarrido-Castro AC, Saura C, Barroso-Sousa R, Guo H, Ciruelos E, Bermejo B, Gavila J, Serra V, Prat A, Pare L, Celiz P, Villagrasa P, Li Y, Savoie J, Xu Z, Arteaga CL, Krop IE, Solit DB, Mills GB, Cantley LC, Winer EP, Lin NU, Rodon J. Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2020 Nov 2;22(1):120. doi: 10.1186/s13058-020-01354-y. PMID 33138866