Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (2)

Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG
from registration
Response rate by RECIST
from registration

Secondary Outcomes (3)

Duration of response by RECIST
from registration
Time to progression
from registration
Toxicity measured by CTC v2.0
from registration

Study Arms (1)

CMF + Herceptin

EXPERIMENTAL

Biological: trastuzumabDrug: CMF regimenDrug: cyclophosphamideDrug: fluorouracilDrug: methotrexate

Interventions

trastuzumabBiological

CMF + Herceptin

CMF regimenDrug

CMF + Herceptin

cyclophosphamide

Eligibility Criteria

Age18 Years - 120 Years

Sexfemale

Healthy VolunteersNo

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer c-erbB2 positive (3+ overexpression by the HercepTest™ method) in the primary tumor or metastatic site * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Lesions that have been irradiated in the preceding 3 months cannot be used as target lesions unless they have appeared or clearly progressed since prior irradiation * No bone lesions as the only target lesions * No contralateral breast cancer that is c-erbB2-positive or c-erbB2-negative/unknown, with status determined on a metastatic site * No CNS metastases * CT scan of brain and CSF cytology are required if neurologic symptoms are present * Hormone receptor status: * Any estrogen or progesterone receptor status PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Any status Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * Transaminases less than 2.5 times ULN (5 times ULN if liver metastases present) Renal: * For patients age 18 to 69: * Creatinine no greater than ULN * For patients age 70 and over: * Creatinine clearance normal Cardiovascular: * LVEF normal by MUGA or echocardiogram * No clinical heart failure Pulmonary: * No malignancy-associated dyspnea at rest * No requirement for supportive oxygen therapy Other: * Not pregnant or nursing * No other prior or concurrent malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude compliance with study therapy and follow-up schedule PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior anti-c-erbB2 antibody, including trastuzumab (Herceptin®) * No other concurrent biologic therapy Chemotherapy: * No more than 1 prior chemotherapy regimen for metastatic breast cancer * Prior combination of cyclophosphamide, methotrexate, and fluorouracil (CMF) allowed in the adjuvant or metastatic setting only if the disease-free interval after completion of CMF was at least 12 months * Prior anthracyclines and/or taxanes allowed * At least 4 weeks since prior anthracyclines * No prior cumulative dose of doxorubicin more than 360 mg/m\^2 * No prior cumulative dose of epirubicin more than 720 mg/m\^2 * No prior cumulative dose of mitoxantrone more than 90 mg/m\^2 * No other concurrent chemotherapy Endocrine therapy: * More than 2 weeks since prior hormonal therapy in the adjuvant or metastatic setting * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer therapy or investigational drugs * No concurrent bisphosphonates started after study enrollment except for hypercalcemia

Sponsors & Collaborators

European Organisation for Research and Treatment of Cancer - EORTC
Research networklead

Study Sites (13)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Institut Jules Bordet

Brussels, 1000, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Herlev Hospital - University Hospital of Copenhagen

Copenhagen, DK-2730, Denmark

National Cancer Institute of Egypt

Cairo, Egypt

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Related Publications (2)

Neskovic-Konstantinovic Z, Nooij M, Khaled H, et al.: Safety and efficacy of combined trastuzumab and CMF therapy in women with metastatic breast cancer: EORTC protocol 10995. [Abstract] J Clin Oncol 25 (Suppl 18): A-1040, 2007.
RESULT
Tryfonidis K, Marreaud S, Khaled H, De Valk B, Vermorken J, Welnicka-Jaskiewicz M, Aalders K, Bartlett JMS, Biganzoli L, Bogaerts J, Cameron D; EORTC- Breast Cancer Group. Cardiac safety, efficacy, and correlation of serial serum HER2-extracellular domain shed antigen measurement with the outcome of the combined trastuzumab plus CMF in women with HER2-positive metastatic breast cancer: results from the EORTC 10995 phase II study. Breast Cancer Res Treat. 2017 Jun;163(3):507-515. doi: 10.1007/s10549-017-4203-y. Epub 2017 Mar 21.
PMID: 28324265DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabCMF regimenCyclophosphamideFluorouracilMethotrexate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, Monoclonal

Study Officials

David Cameron
Western General Hospital, Edinburgh
STUDY CHAIR

Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

CMF + Herceptin

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

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

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

CMF + Herceptin

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations