Conditions

Breast Cancer

Keywords

recurrent breast cancer

Interventions

marimastatDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast with previous manifestations of progressing regional or metastatic cancer Received one prior systemic chemotherapy regimen for the treatment of metastases, which meets all of the following criteria: Included either doxorubicin, a taxane (i.e., paclitaxel or docetaxel), or both 6-8 courses were given If weekly taxane therapy received, at least 12 doses were given Recovered from all related toxic effects (except alopecia and/or neuropathy) 3-6 weeks have elapsed since last course of chemotherapy was given No more than 40 weeks have elapsed since the first dose of chemotherapy for metastases No current or prior history of brain metastases Responding or stable disease since the initiation of systemic chemotherapy (i.e., no disease progression) required No prior enrollment on ECOG trials for metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal Status: Not specified Performance status: ECOG 0 or 1 Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test required if pre- or peri-menopausal (i.e., last menstrual period within one year prior to study) Pre- or peri-menopausal sexually active women must use effective contraception No other invasive malignancy within last 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No history of rheumatoid arthritis, osteoarthritis, symptomatic osteoarthritis requiring therapy, or other inflammatory arthritis At least 5 years since prior invasive malignancies except: Curatively treated basal cell or squamous cell carcinoma of the skin Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No prior trastuzumab Chemotherapy: See Disease Characteristics No concurrent chemotherapy No prior marimastat or batimastat Endocrine therapy: Prior and/or concurrent hormonal therapy for breast cancer allowed Concurrent hormonal therapy allowed Radiotherapy: No concurrent radiotherapy Surgery: No prior organ allograft Other: At least 4 weeks since other investigational agents No concurrent bisphosphonate therapy unless it was initiated prior to the study No concurrent immunosuppressive therapy Patients receiving anticoagulant therapy must be carefully monitored

Sponsors & Collaborators

Eastern Cooperative Oncology Group
Research networklead
North Central Cancer Treatment Group
Research networkcollaborator
National Cancer Institute (NCI)

Study Sites (25)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

CCOP - Wichita

Related Publications (3)

Zucker S, Wang M, Sparano JA, Gradishar WJ, Ingle JN, Davidson NE; Eastern Cooperative Oncology Group. Plasma matrix metalloproteinases 7 and 9 in patients with metastatic breast cancer treated with marimastat or placebo: Eastern Cooperative Oncology Group trial E2196. Clin Breast Cancer. 2006 Feb;6(6):525-9. doi: 10.3816/cbc.2006.n.006.
PMID: 16595036RESULT
Sparano JA, Bernardo P, Stephenson P, Gradishar WJ, Ingle JN, Zucker S, Davidson NE. Randomized phase III trial of marimastat versus placebo in patients with metastatic breast cancer who have responding or stable disease after first-line chemotherapy: Eastern Cooperative Oncology Group trial E2196. J Clin Oncol. 2004 Dec 1;22(23):4683-90. doi: 10.1200/JCO.2004.08.054.
PMID: 15570070RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

marimastat

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Joseph A. Sparano, MD
Albert Einstein College of Medicine
STUDY CHAIR
James N. Ingle, MD
Mayo Clinic
STUDY CHAIR

Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (25)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (25)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations