Clinical trial · Interventional
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
A Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC)
- 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 primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV LBH589 | Drug | Panobinostat | ALIAS |
| Oral LBH589 | Drug | Panobinostat | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IV LBH589 + trastuzumab + paclitaxel
- description
- i.v. panobinostat
- interventionNames
- Drug: IV LBH589
- Drug: trastuzumab
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- Oral LBH589 + trastuzumab + paclitaxel
- description
- oral panobinostat
- interventionNames
- Drug: IV LBH589
- Drug: Oral LBH589
- Drug: trastuzumab
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 year old * Confirmed HER2+ metastatic breast cancer * Prior treatment and progression on trastuzumab * Patients must have adequate organ functions * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: * Patients who have had surgery within last 2 weeks prior to starting the treatment * Patients who receive concurrent therapy for brain metastases * Impaired heart function or clinically significant heart disease * 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 Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available