Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer
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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.
Condition or disease
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 breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.
A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients With Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Cancer Following Standard First-Line Endocrine Therapy
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.