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Phase II Randomized Double-Blind Evaluation of Two Dose Levels of LY353381 Hydrochloride Administered to Women With Locally Advanced or Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Randomized Double-Blind Evaluation of Two Dose Levels of LY353381 Hydrochloride Administered to Women With Locally Advanced or Metastatic Breast Cancer

OBJECTIVES: I. Compare the response rate or clinical benefit rate in patients with locally
advanced or metastatic breast cancer treated with 1 of 2 different doses of arzoxifene
hydrochloride. II. Compare the response rates and clinical benefit rates for patients with
tamoxifen-sensitive versus tamoxifen-refractory disease. III. Compare the degree of toxicity
between the 2 doses of arzoxifene hydrochloride in these patients. IV. Compare the quality
of life and survival of these patients receiving high versus low dose arzoxifene
hydrochloride. V. Determine the time to progressive disease, time to treatment failure, and
response duration of this treatment in these patients. VII. Measure changes in serum
estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding
globulin in these patients during treatment.

OUTLINE: This is a randomized, double blind study. Patients are stratified according to
number of metastatic sites (less than 3 vs 3 or more), tamoxifen sensitivity (sensitive vs
refractory), and degree of estrogen receptor positivity (high vs low vs unknown). Patients
are randomized to receive 1 of 2 doses of arzoxifene hydrochloride. Patients receive
arzoxifene hydrochloride orally once daily for 12 weeks. Treatment continues in the absence
of toxicity and disease progression. Quality of life is assessed before, during, and at the
completion of the study. Patients are followed every 4 weeks for 12 weeks, at 30 days after
the last treatment, and every 2-3 months after the last treatment.

PROJECTED ACCRUAL: This study will accrue 104-114 patients.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven locally advanced or metastatic breast
cancer and meeting one of the following criteria: No prior systemic therapy OR Relapsed
more than 12 months after stopping adjuvant tamoxifen (tamoxifen- sensitive) OR Relapsed
while receiving adjuvant tamoxifen for more than 12 months (tamoxifen-refractory) OR
Disease progression while receiving tamoxifen as first-line treatment for metastatic
breast cancer (tamoxifen-refractory) Evaluable or bidimensionally measurable disease No
rapid disease progression requiring chemotherapy Brain metastases allowed if stable for at
least 6 months after surgery or radiotherapy, with no increase in corticosteroids Hormone
receptor status: Estrogen receptor positive AND/OR Progesterone receptor positive OR
Unknown status allowed if over 50 years old

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-1 Life expectancy: At least 24 weeks Hematopoietic: Granulocyte
count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL,
transfusion independent Hepatic: Bilirubin no greater than 1.5 times normal PT/PTT no
greater than 1.25 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN
Renal: Creatinine less than 1.5 times ULN Calcium no greater than 11 mg/dL No
hypercalcemia Other: Not pregnant or nursing Fertile patients must use approved
nonhormonal contraceptive during and for 3 months after study No known predisposition to
thromboembolic disorder At least 5 years since other primary malignancy except: Adequately
treated nonmelanomatous skin cancer Carcinoma in situ of the cervix No serious concurrent
systemic disorders incompatible with study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Concurrent
hematopoietic growth factor allowed Chemotherapy: No prior chemotherapy for metastatic
breast cancer No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy for
metastatic breast cancer (except tamoxifen) No concurrent supplemental estrogen or
progesterone At least 3 weeks since prior estrogen replacement therapy No other concurrent
hormone therapy Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: Not
specified Other: At least 4 weeks since prior use of other investigational agents
Concurrent bisphosphonate therapy allowed No other concurrent investigational agent

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Clifford A. Hudis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

June 2001

Related Keywords:

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



Memorial Sloan-Kettering Cancer Center New York, New York  10021