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
  Purpose

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 Intervention Phase
Breast Cancer
Drug: TAS-108
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Cancer Following Standard First-Line Endocrine Therapy

Resource links provided by NLM:


Further study details as provided by SRI International:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 180
Study Start Date: May 2004
Study Completion Date: March 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166543

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
SRI International
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: James N. Ingle, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: SRI International
ClinicalTrials.gov Identifier: NCT00166543     History of Changes
Obsolete Identifiers: NCT00687557
Other Study ID Numbers: 2216-03, TAS108-0004
Study First Received: September 12, 2005
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SRI International:
locally advanced breast carcinoma
locally recurrent inoperable breast carcinoma
progressive metastatic breast carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014