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

Phase 2
18 Years
Not Enrolling
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

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


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


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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed stage IV adenocarcinoma
of the breast; tumor blocks and/or slides from original diagnosis or metastatic
work-up must be available for correlative studies

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >
20 mm with conventional techniques or as > 10 mm with spiral CT scan

- Prior adjuvant therapy, and up to 2 lines of prior chemotherapy (including
trastuzumab containing regimens in Her-2 positive patients) for metastatic disease
are allowed; prior radiation therapy is allowed, prior hormonal therapy is allowed

- Life expectancy of greater than 6 months

- Performance status: ECOG 0- 2

- Absolute neutrophil count >= 1,000/μl

- Platelets >= 100,000/μl

- Serum creatinine =< 1.6 mg/dl or calculated measured clearance >= 60 cc/min

- Total bilirubin =< 2 mg/dL

- AST and ALT =< 3 times institutional upper normal level

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the activity or pharmacokinetics of SAHA will be
determined following review by the Principal Investigator

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document

- Patients should not have taken valproic acid for at least two weeks prior to study

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- Patients with known brain metastases are excluded from this clinical trial unless the
metastases are controlled after therapy and have not been treated with steroids
within the past two months

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to SAHA; these compounds include sodium butyrate, trichostatin A (TSA),
trapoxin (TPX), MS-27-275 and depsipeptide

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because SAHA is a HDAC inhibitor agent
with an unknown potential for teratogenesis; because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with SAHA, breastfeeding should be discontinued if the mother is treated with

- HIV-positive patients receiving combination antiretroviral therapy are ineligible
because of the potential for pharmacokinetic interactions with SAHA

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate according to the RECIST criteria

Outcome Description:

Response rates (RECIST) will be calculated as the percent of treated patients whose best response is a CR or PR, and exact 95% confidence intervals will be calculated for this estimate (reflecting the interim analysis).

Outcome Time Frame:

Up to 8 weeks

Safety Issue:


Principal Investigator

Thehang Luu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



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