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

July 28, 2015 updated by: SRI International

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 4 years and 3 months
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
Up to 4 years and 3 months
To determine the time to progression of TAS-108 administered on this schedule
Time Frame: Up to 4 years and 3 months
Up to 4 years and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SRI International

Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: James N. Ingle, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2216-03
  • TAS108-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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