A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer

Novartis

Status and phase: Completed; Phase 1

Conditions: Metastatic Breast Cancer; HER-2 Positive Breast Cancer

Treatments: Drug: IV LBH589; Drug: Oral LBH589; Drug: trastuzumab; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788931

2007-004788-23 (EudraCT Number)

CLBH589C2114

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

IV LBH589 + trastuzumab + paclitaxel

Experimental group

Description:

i.v. panobinostat

Treatment:

Drug: trastuzumab

Drug: paclitaxel

Drug: IV LBH589

Oral LBH589 + trastuzumab + paclitaxel

Experimental group

Description:

oral panobinostat

Treatment:

Drug: trastuzumab

Drug: paclitaxel

Drug: Oral LBH589

Drug: IV LBH589