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

This study has been completed.
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
SRI International
ClinicalTrials.gov Identifier:
NCT00166543
First received: September 12, 2005
Last updated: May 13, 2014
Last verified: February 2011

September 12, 2005
May 13, 2014
May 2004
Not Provided
  • To evaluate the safety of TAS-108 administered on this schedule
  • To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state
  • To determine the time to progression of TAS-108 administered on this schedule
Same as current
Complete list of historical versions of study NCT00166543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Breast Cancer
Drug: TAS-108
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
March 2008
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166543
2216-03, TAS108-0004
Not Provided
SRI International
SRI International
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: James N. Ingle, M.D. Mayo Clinic
SRI International
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP