A dose-finding phase II study of TAS-108

Phase 2

• Conditions: Postmenopausal patients with breast cancer

• Registration Number: JPRN-jRCT2080221712
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: Not specified

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified