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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: TAS-108

• Registration Number: NCT00166543
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2015-06
• Disposition First Submitted: 2015-06-26
• Disposition First Submitted QC: 2015-06-26
• Last Update Submitted: 2015-07-28
• Disposition First Posted: 2015-08-18
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAS-108 80 mg	TAS-108	-
TAS-108 120 mg	TAS-108	-
TAS-108 40 mg	TAS-108	-

Primary Outcome Measures

Name	Time	Method
To determine the time to progression of TAS-108 administered on this schedule	Up to 4 years and 3 months
To evaluate the safety of TAS-108 administered on this schedule	Up to 4 years and 3 months	Treatment-emergent adverse events, serious adverse events, bone mineral density
To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state	Up to 4 years and 3 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States