Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer

This study has been terminated.
(Withdrawn due to change in standard of care - new protocol required)
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT00010322
First received: February 2, 2001
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight breast cancer by blocking the production of estrogen. It is not yet known if toremifene is more effective with or without atamestane.

PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: atamestane
Drug: toremifene
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

Study Start Date: October 2000
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 central nervous system (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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010322

Locations
United States, New York
Millennix Inc.
Purchase, New York, United States, 10577
Sponsors and Collaborators
Intarcia Therapeutics
Investigators
Study Chair: Peter Langecker, MD, PhD Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT00010322     History of Changes
Other Study ID Numbers: CDR0000068480, BIOMED-777-CLP-27
Study First Received: February 2, 2001
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Intarcia Therapeutics:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Atamestane
Toremifene
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014