Status:
COMPLETED
Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer
Lead Sponsor:
SRI International
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.
Detailed Description
The objective of this study is to investigate the efficacy and safety of TAS-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Postmenopausal females
- Histologically or cytologically confirmed diagnosis of breast carcinoma
- Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
- Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
- Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
- Performance status of greater than or equal to 2 on the Zubrod scale
- Predicted life expectancy of greater than or equal to 12 weeks
- Must give written informed consent
- Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL
- Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
- Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
- The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade 1.
- All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00166543
Start Date
May 1 2004
End Date
January 1 2008
Last Update
August 18 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905