Clinical Trial: Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) as Salvage Therapy in Metastatic Breast Cancer

Brief Summary: This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed Summary:

PRIMARY OBJECTIVES:

I. To evaluate the response rate in patients receiving SAHA for stage IV breast cancer.

SECONDARY OBJECTIVES:

I. Time to progression. II. Overall survival. III. Toxicity profile. IV. Assessment of potential biological correlates.

OUTLINE: This is a multicenter study.

Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 8 weeks.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Objective Tumor Response Rate [ Time Frame: Up to 8 weeks ]

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR


Original Primary Outcome:

Current Secondary Outcome:

  • Overall Survival [ Time Frame: From the initial date of treatment to time of death, up to 5 years. ]
    Estimated using the product-limit method of Kaplan and Meier.
  • Progression-free Survival [ Time Frame: From start of treatment to the time of documented progression, assessed up to 5 years ]
    Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 16, 2005
Date Started: June 2005
Date Completion:
Last Updated: March 6, 2015
Last Verified: February 2013