Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SRI International
• Collaborator: Taiho Pharmaceutical Co., Ltd.
• Treatments: Estradiol

Criteria

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.