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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00166543
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : August 18, 2015
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
SRI International

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: TAS-108 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : May 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TAS-108 40 mg Drug: TAS-108
Experimental: TAS-108 80 mg Drug: TAS-108
Experimental: TAS-108 120 mg Drug: TAS-108

Primary Outcome Measures :
  1. To evaluate the safety of TAS-108 administered on this schedule [ Time Frame: Up to 4 years and 3 months ]
    Treatment-emergent adverse events, serious adverse events, bone mineral density

  2. To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state [ Time Frame: Up to 4 years and 3 months ]
  3. To determine the time to progression of TAS-108 administered on this schedule [ Time Frame: Up to 4 years and 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00166543

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

Responsible Party: SRI International Identifier: NCT00166543     History of Changes
Obsolete Identifiers: NCT00687557
Other Study ID Numbers: 2216-03
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: June 2015

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
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs