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

S

Stanford Research Institute (SRI) International

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: TAS-108

Study type

Interventional

Funder types

Industry

Identifiers

NCT00166543
2216-03
TAS108-0004

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

146 participants in 3 patient groups

TAS-108 40 mg
Experimental group
Treatment:
Drug: TAS-108
TAS-108 80 mg
Experimental group
Treatment:
Drug: TAS-108
TAS-108 120 mg
Experimental group
Treatment:
Drug: TAS-108

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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