search
Back to results

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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
atamestane
toremifene
Sponsored by
Intarcia Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Millennix Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
March 24, 2014
Sponsor
Intarcia Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT00010322
Brief Title
Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer
Official Title
Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to change in standard of care - new protocol required
Study Start Date
October 2000 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
May 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intarcia Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
atamestane
Intervention Type
Drug
Intervention Name(s)
toremifene

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Langecker, MD, PhD
Organizational Affiliation
Intarcia Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Millennix Inc.
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs