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

NCT00166543 | Completed Phase 2

• 2 other identifiers: 2216-03TAS108-0004
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

locally advanced breast carcinoma; locally recurrent inoperable breast carcinoma; progressive metastatic breast carcinoma

Outcome Measures

Primary Outcomes (3)

• To evaluate the safety of TAS-108 administered on this schedule

  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

  Up to 4 years and 3 months

• To determine the time to progression of TAS-108 administered on this schedule

  Up to 4 years and 3 months

Study Arms (3)

TAS-108 40 mg

EXPERIMENTAL

Drug: TAS-108

TAS-108 80 mg

EXPERIMENTAL

Drug: TAS-108

TAS-108 120 mg

EXPERIMENTAL

Drug: TAS-108

Interventions

TAS-108 DRUG

TAS-108 120 mg; TAS-108 40 mg; TAS-108 80 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• SRI International: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TS 108

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James N. Ingle, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 18, 2015

Record last verified: 2015-06

Locations

US (1)