A phase II study of metronomic oral chemoterapy with Cyclophosphamide plus Capecitabine combined with Trastuzumab in advanced breast cancer - ND

GOIM GRUPPO ONCOLOGICO MERIDIONALE0 sitesApril 9, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pre-or post-menopausal women with histologically proven, locally advanced (inoperable) or metastatic breast cancer.
Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

April 9, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

GOIM GRUPPO ONCOLOGICO MERIDIONALE

•Pre\- or post\-menopausal women with histologically proven, locally advanced (inoperable) or metastatic breast carcinoma. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. No previous lines of chemotherapy for advanced disease (primary and/or adjuvant chemotherapy are allowed, as well as any prior endocrine treatment; prior primary and/or adjuvant trastuzumab therapy are allowed, if ended  6 months before. At least 4 weeks must have elapsed since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included mitomycin C). Age \>18 years and \< 80 years. ECOG performance status \<2 (Karnofsky \>60% Normal organ and marrow function Ability to understand and the willingness to sign a written informed consent document
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•Presence of cerebral or leptomeningeal involvement. Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab or other agents used in the study Seriuos cardiac illness \-Poorly controlled hypertension Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, renal failure, or psychiatric illness/social situations that would limit compliance with study requirements.