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Sponsors and Collaborators: |
Taiho Pharma USA, Inc. Quintiles |
---|---|
Information provided by: | Taiho Pharma USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00687557 |
The purpose of this research study is to evaluate the safety and effectiveness of TAS-108, an investigational drug, when administered to postmenopausal patients with advanced breast cancer.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: TAS-108 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 Carcinoma Following Standard First or Second Line Endocrine Therapy |
Estimated Enrollment: | 180 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
TAS-108 orally administered once daily (QD) within 30 minutes after the first meal of the day at 40 mg
|
Drug: TAS-108
TAS-108 orally administered once daily (QD) within 30 minutes after the first meal of the day at 40 mg, 80 mg, or 120 mg
|
B: Experimental
TAS-108 orally administered once daily (QD) within 30 minutes after the first meal of the day at 80 mg
|
Drug: TAS-108
TAS-108 orally administered once daily (QD) within 30 minutes after the first meal of the day at 40 mg, 80 mg, or 120 mg
|
C: Experimental
TAS-108 orally administered once daily (QD) within 30 minutes after the first meal of the day at 120 mg
|
Drug: TAS-108
TAS-108 orally administered once daily (QD) within 30 minutes after the first meal of the day at 40 mg, 80 mg, or 120 mg
|
Many kinds of chemotherapeutic agents and anti-hormone agents have been developed for breast cancer treatment, and for breast cancer prevention. It is obvious that some of these agents, especially tamoxifen in an adjuvant setting, have clearly contributed to the reduction of the incidence of breast cancer recurrence, and consequently reduction in mortality. However, most breast cancer patients after long-term treatment of tamoxifen show progression, indicated by tumor recurrence and metastasis, which is indicative of tamoxifen resistance. In order to overcome such clinical limitations of tamoxifen treatment, aromatase inhibitors (AIs) and selective estrogen receptor down-regulators (SERDs) have been clinically investigated. It is unclear whether AIs and SERDs are as beneficial as tamoxifen for prevention of bone fractures and cardiovascular risk factors caused by enhanced lipid in their long-term treatment of postmenopausal women with ER-positive advanced breast cancer and in adjuvant treatment of postmenopausal women after surgery for breast cancer. Based on preclinical data, TAS-108, a novel oral anti-estrogen compound, may be a superior drug compared to tamoxifen and AIs in a clinical setting. Therefore, a phase II study was planned for patients who are ER/PgR positive, with locally advanced or locally recurrent inoperable or progressive metastatic breast cancer following first or second line endocrine therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has any other serious illness or medical condition(s) including, but not limited to, the following:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
Barnes Jewish Hospital | |
St. Louis, Missouri, United States, 63110 | |
Russian Federation | |
St. Petersburg Pavlov State Medical University | |
St. Petersburg, Russian Federation, 197089 | |
Blokhin Cancer Research Center | |
Moscow, Russian Federation, 115478 |
Responsible Party: | Taiho Pharma USA, Inc. ( Peter Urrea/Senior VP, Clinical and Regulatory Affairs ) |
Study ID Numbers: | TAS108-0004 |
Study First Received: | May 28, 2008 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00687557 |
Health Authority: | United States: Food and Drug Administration |
Postmenopausal Patients with Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Carcinoma |
Skin Diseases Breast Neoplasms Breast Diseases |
Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site |