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Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer


OBJECTIVES: I. Compare the time to progression in postmenopausal women with metastatic
breast cancer treated with toremifene with or without atamestane. II. Compare the response
rate, overall survival, duration of response, and time to treatment failure in patients
treated with these regimens. III. Compare the safety profile of these regimens in this
patient population.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to study center. Patients are randomized to one of two treatment
arms. Arm I: Patients receive oral toremifene daily and oral atamestane twice daily. Arm II:
Patients receive oral toremifene as in arm I and an oral placebo twice daily. Treatment
continues for 12-30 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 594 patients (297 per treatment arm) will be accrued for this
study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally
measurable disease Lesion at least 2 cm in at least 1 diameter No failure with prior
adjuvant antiestrogens within the first 12 months of treatment No progression of disease
during therapy with prior aromatase inhibitors or selective estrogen receptor modulators
(SERMs) (including SERMs for prevention of osteoporosis) No history of known CNS
metastases No bone metastases as only tumor manifestation Hormone receptor status:
Estrogen receptor and/or progesterone receptor positive

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Postmenopausal
Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin
at least 9 g/dL Platelet count at least 100,000/mm3 WBC at least 2,000/mm3 Hepatic: AST
and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than
2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No significant
neurological dysfunction including seizures or clinical signs of other significant
neurological diseases No other active malignancy within the past 5 years except basal cell
skin cancer or carcinoma in situ of the cervix No contraindication to toremifene or its
excipients or any of the excipients in atamestane Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic
chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No
concurrent chemotherapy Endocrine therapy: See Disease Characteristics No prior hormonal
therapy for metastatic disease At least 12 months since prior adjuvant antiestrogens No
concurrent SERMs or estrogenic or androgenic hormones No other concurrent aromatase
inhibitors Radiotherapy: No concurrent radiotherapy except for palliation for bone
metastases Surgery: Not specified Other: No prior enrollment in this study At least 30
days since prior investigational drugs No other concurrent investigational drugs
Concurrent bisphosphonates for bone metastases allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter Langecker, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Intarcia Therapeutics

Authority:

United States: Federal Government

Study ID:

CDR0000068480

NCT ID:

NCT00010322

Start Date:

October 2000

Completion Date:

Related Keywords:

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

Name

Location
Millennix Inc. Purchase, New York  10577