Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer
|ClinicalTrials.gov Identifier: NCT00365599|
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : March 26, 2012
Last Update Posted : November 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: suberoylanilide hydroxamic acid (SAHA, Vorinostat) Drug: tamoxifen citrate (Tamoxifen)||Phase 2|
Phase II trial to explore the efficacy of vorinostat and tamoxifen combined. Tamoxifen will be given once daily, continuously. Vorinostat will be given daily for 3 out of 4 weeks (a cycle). Responses will be assessed (restaged) after 2 cycles and toxicities will be captured continuously. Eligible patients will receive treatment in consecutive 4-week cycles, until progression of disease or unacceptable toxicity. Patients will be followed for evaluation of safety for at least 30 days after the last dose of the study drug.
Tests will be obtained pre-and post vorinostat treatment and correlated with plasma levels of vorinostat at the time of tumor biopsy and vorinostat doses; the tests will consist of:
- Patient history
- Physical exam (including height and weight)
- Toxicity assessment
- Pharmacokinetic (PK) sample
- Tumor fine needle aspirate (FNA)
- Peripheral Blood Mononuclear Cells (PBMC)
- Standard labs and Chemistry Profile
- Carcinoembryonic antigen (CEA), cancer antigen (Ca) 15-3, Ca 125 (If clinically indicated)
- Pregnancy Test
- Computed tomography (CT) scans, and magnetic resonance imaging (MRI)
Documentation of response and progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) in Combination With Tamoxifen for Patients With Advanced Breast Cancer Who Have Failed Prior Anti-hormonal Therapy.|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||August 2012|
Experimental: Vorinostat and Tamoxifen
As outlined in Intervention descriptions
Drug: suberoylanilide hydroxamic acid (SAHA, Vorinostat)
Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).
Other Names:Drug: tamoxifen citrate (Tamoxifen)
Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).
- Number of Participants With Objective Response (OR) [ Time Frame: 24 weeks ]The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.
- Time to Progression (TTP) [ Time Frame: Up to 30 months ]The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 4 years, 7 months ]Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365599
|United States, California|
|University of California|
|San Francisco, California, United States, 94143|
|United States, Florida|
|Bethesda Memorial Hospital Research Center|
|Boynton Beach, Florida, United States, 33435|
|M.D. Anderson of Orlando|
|Orlando, Florida, United States, 32806|
|Fawcett Memorial Hospital|
|Port Charlotte, Florida, United States, 33949|
|Martin Memorial Cancer Center|
|Stuart, Florida, United States, 34994|
|Tallahassee Memorial HealthCare, Inc.|
|Tallahassee, Florida, United States, 32308|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Savannah, Georgia, United States, 31405|
|Principal Investigator:||Susan Minton, D.O.||H. Lee Moffitt Cancer Center and Research Institute|