Clinical trial · Interventional
A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab
A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated early due to insufficient evidence of clinical benefit.
Summary
Brief summary (as posted)
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panobinostat | Drug | Panobinostat | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panobinostat with trastuzumab
- description
- Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
- interventionNames
- Drug: Panobinostat
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- day 21
- description
- Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion criteria: * Age \> 18 year old * Confirmed HER2+ ve metastatic breast cancer * Prior treatment and progression on trastuzumab * Patients must have adequate laboratory values * Eastern Cooperative Oncology Group (ECOG) performance status of \<2 Key Exclusion criteria: * Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months. * Impaired heart function or clinically significant heart disease * Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589 * Ongoing diarrhea * Liver or renal disease with impaired hepatic or renal functions * Concomitant use of any anti-cancer therapy or certain drugs * Female patients who are pregnant or breast feeding * Patients not willing to use an effective method of birth control
References
Publications (0)
Data not yet available