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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)


Phase 1
18 Years
N/A
Not Enrolling
Female
HER-2 Positive Breast Cancer, Metastatic Breast Cancer

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

At least 21 day cycle for both arms

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589C2114

NCT ID:

NCT00788931

Start Date:

December 2008

Completion Date:

Related Keywords:

  • HER-2 Positive Breast Cancer
  • Metastatic Breast Cancer
  • Breast Cancer
  • HER2 positive
  • adult-female
  • LBH589
  • HDAC inhibitor
  • panobinostat
  • metastatic breast
  • adult female patients
  • Breast Neoplasms

Name

Location

Novartis Investigative SiteBirmingham, Alabama  35294