Ganetespib, Paclitaxel and Trastuzumab for Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer
This phase I trial studies the side effects and best dose of ganetespib when given with paclitaxel and trastuzumab in treating patients with advanced or metastatic human epidermal growth factor receptor 2 positive (HER2+) breast cancer. HER2+ describes cancer cells that have too much of a protein called HER2 on their surface. In normal cells, HER2 helps to control cell growth. When it is made in larger than normal amounts by cancer cells, the cells may grow more quickly and be more likely to spread to other parts of the body. Checking to see if a cancer is HER2+ may help plan treatment, which may include drugs that kill HER2+ cancer cells. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block the ability of tumors to grow and spread. Giving ganetespib with paclitaxel and trastuzumab may be an effective treatment for patients with HER2+ breast cancer.
HER2-positive Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Clinical Trial of Ganetespib (Heat Shock Protein 90 Inhibitor) in Combination With Paclitaxel and Trastuzumab in Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Metastatic Breast Cancer|
- Maximum tolerated dose (MTD) of ganetespib when combined with paclitaxel and trastuzumab [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Objective Response Rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Defined as the percentage of patients who have achieved complete response or partial response assessed based on Response evaluation criteria in solid tumors 1.1 (RECIST 1.1).
- Clinical benefit rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Defined as the percentage of patients who have achieved complete response, partial response, or stable disease for at least 24 weeks assessed based on RECIST 1.1.
- Duration of response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The duration of response is measured from the time of response to disease progression.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The median time of progression-free survival will be calculated.
- PK parameters of paclitaxel (such as area under the curve and maximum concentration) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 7, 21, 24, 27, and 31 hours ] [ Designated as safety issue: No ]Will be examined descriptively to evaluate the effect of ganetespib on the paclitaxel absorption.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: ganetespib, paclitaxel, and trastuzumab
Patients receive trastuzumab IV over 30 minutes on days 1, 8, 15, and 22, paclitaxel IV over 1 hour on days 1, 8, 15, and 22, and ganetespib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Other Names:Drug: paclitaxel
Other Names:Biological: trastuzumab
I. To establish the safety, tolerability, maximum tolerated dose (MTD) and the recommended phase II dose of ganetespib plus paclitaxel in conjunction with trastuzumab in patients with HER2+ metastatic breast cancer (MBC).
I. To evaluate the possible effects of ganetespib on the pharmacokinetics (PK) of paclitaxel.
II. To make a preliminary assessment of the efficacy of the combination of ganetespib, paclitaxel and trastuzumab as measured by objective response rate (ORR), progression-free survival (PFS), duration of response, and clinical benefit rate (complete response + partial response + stable disease > 24 weeks).
Patients receive trastuzumab IV over 30 minutes on days 1, 8, 15, and 22, paclitaxel IV over 1 hour on days 1, 8, 15, and 22, and ganetespib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02060253
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Shanu Modi 646-888-5243 email@example.com|
|Principal Investigator: Shanu Modi|
|NYU Cancer Institute||Recruiting|
|New York, New York, United States, 10016|
|Contact: Komal Jhaveri 212-731-5835 Komal.Jhaveri@nyumc.org|
|Principal Investigator: Komal Jhaveri|
|Principal Investigator:||Komal Jhaveri||New York University School of Medicine|