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A Phase II, Randomized, Double-Masked, Multicenter Study of Two Dose Levels of ERA-923 for the Treatment of Metastatic Breast Cancer in Postmenopausal Women Who Have Failed Tamoxifen Therapy


Phase 2
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase II, Randomized, Double-Masked, Multicenter Study of Two Dose Levels of ERA-923 for the Treatment of Metastatic Breast Cancer in Postmenopausal Women Who Have Failed Tamoxifen Therapy


OBJECTIVES: I. Compare the efficacy of 2 dose levels of ERA-923 in postmenopausal patients
with metastatic breast cancer refractory to tamoxifen. II. Determine the safety and plasma
levels of this drug in these patients. III. Determine the impact on quality of life of these
patients by this drug.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to
one of two treatment arms receiving different doses of ERA-923. Patients receive oral
ERA-923 daily for 48 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline; at weeks 4, 8, 16, 24, 32, 40, and 48; and then at
4 weeks after last dose. Patients are followed at 4 weeks and then every 3 months
thereafter.

PROJECTED ACCRUAL: At total of 36-100 patients (18-50 per arm) will be accrued for this
study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of metastatic breast cancer Prior tamoxifen therapy
failure within 1 year of study defined as follows: Prior tamoxifen therapy for metastatic
disease with prior response and progression of disease while still on treatment or within
1 year of last treatment Prior adjuvant tamoxifen therapy for a minimum of 2 years with
subsequent progression of disease while still on treatment or within 1 year of last
treatment Postmenopausal Must be amenorrheic for at least 12 months Removal of both
ovaries or chemotherapy induced menopause allowed At least 1 bideminsionally measurable
lesion No disease restricted only to bone No symptomatic CNS metastases untreated by
surgery or radiotherapy Hormone receptor status: Estrogen or progesterone receptor
positive

PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Postmenopausal Performance
status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.0
g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no
greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) PT and
PTT no greater than 1.25 times ULN Renal: Creatinine no greater than 1.5 times ULN
Cardiovascular: No deep vein thrombosis, retinal vein thrombosis, or stroke within past
year No unstable angina or myocardial infarction within past 6 months Pulmonary: No
pulmonary embolism within past year Other: Not pregnant or nursing No other major illness
or condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent trastuzumab (Herceptin)
Chemotherapy: No more than 2 prior chemotherapy regimens, including trastuzumab One
regimen in adjuvant setting and one in metastatic setting OR Two regimens in metastatic
setting No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least
6 months since prior raloxifene for osteoporosis No prior hormonal, antiestrogen, or
aromatase inhibitors other than tamoxifen for breast cancer At least 4 weeks since prior
tamoxifen No concurrent hormonal replacement therapy, other antiestrogens (including
raloxifene), aromatase inhibitors, or systemic steroids (except physiologic replacement
doses) Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Other: At least 4 weeks since prior investigational drug No concurrent warfarin exept low
dose warfarin for port maintenance No other concurrent investigational agent No concurrent
immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan Minton, DO

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068242

NCT ID:

NCT00006369

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612