Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

James N. Ingle, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

2216-03

NCT ID:

NCT00166543

Start Date:

May 2004

Completion Date:

March 2008

Related Keywords:

  • Breast Cancer
  • locally advanced breast carcinoma
  • locally recurrent inoperable breast carcinoma
  • progressive metastatic breast carcinoma
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905