NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Postmenopausal patients with breast cancer
Date of first enrollment	20/02/2012
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TAS-108 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral TAS-108 (40, 80, or 120 mg/day) will be administered daily after breakfast.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 80age old
Gender	Female
Include criteria	(1) Have a cytologically or histologically confirmed breast cancer as the primary lesion (2) Postmenopausal women 20 to 80 years of age who meet one of the following conditions: 1) Women 50 years of age or older and amenorrheic for at least 12 months 2) Women less than 50 years of age, amenorrheic for at least 12 months, and with both serum estradiol-17 beta (E2) and follicle-stimulating hormone (FSH) levels in the postmenopausal range of each institution* (patients with luteinizing hormone-releasing hormone (LH-RH) agonist-induced menopause will be excluded from this study) 3) Women less than 50 years of age, amenorrheic for at least 3 months by irradiation, and with both serum E2 and FSH levels in the postmenopausal range of each institution* *E2 and FSH tests are not required in patients who have undergone bilateral oophorectomy. (3) Have estrogen receptor (ER)-positive or progesterone receptor (PgR)-positive breast cancer (4) Have at least one measurable lesion the size of which has been measured within 4 weeks prior to enrollment
Exclude criteria