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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00788931

Enrollment

Registered

2008-11-11

Start date

2008-12-31

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER-2 Positive Breast Cancer, Metastatic Breast Cancer

Keywords

Breast Cancer, HER2 positive, adult-female, LBH589, HDAC inhibitor, panobinostat, metastatic breast, adult female patients

Brief summary

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

Interventions

DRUGIV LBH589

DRUGOral LBH589

DRUGtrastuzumab

DRUGpaclitaxel

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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.	At least 21 day cycle for both arms

Secondary

Measure	Time frame
Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.	4 weeks after end of treatment
To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.	throughout the study and 4 weeks after end of treatment

Countries

Australia, Belgium, Italy, Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026