NCT00010322

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

May 5, 2004

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

7 months

First QC Date

February 2, 2001

Last Update Submit

March 24, 2014

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

atamestaneDRUG
toremifeneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Millennix Inc.

Purchase, New York, 10577, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

atamestaneToremifene

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Peter Langecker, MD, PhD

    Intarcia Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

May 5, 2004

Study Start

October 1, 2000

Primary Completion

May 1, 2001

Study Completion

May 1, 2001

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)