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

Completed · Phase 1

Conditions studied: HER-2 Positive Breast Cancer, Metastatic Breast Cancer

In brief

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

Key facts

Study ID

NCT00788931

Run by

Novartis Pharmaceuticals

People needed

15

Starts

2008-12-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Woodville, South Australia, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Province of Macerata, MC, Italy
• Novartis Investigative Site — Aviano, PN, Italy
• Novartis Investigative Site — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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