A GOIRC Phase II randomized trial of an oral chemotherapy combination of Capecitabine plus Vinorelbine and their sequential single agent use in Metastatic Breast Cancer - ND

• Conditions: Metastatic breast cancer

• Registration Number: EUCTR2009-013472-41-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Patients must be older than 18 years Performance status ECOG 0-2 Histologic or cytologic diagnosis of adenocarcinoma originating in the breast. Evidence that the cancer is metastatic and not curable by local measures (i.e. radiation). Measurable disease which has to be assessed using RECIST criteria. Moreover, target lesions have not to be chosen from a previously irradiated area unless the lesion has appeared as a new lesion after completion of radiation therapy. Patients have to be treated with both an anthracycline (i.e.: doxorubicin or epirubicin) and a taxane (i.e.: paclitaxel or docetaxel). To enter the study, patients who received both class of agents in the neoadjuvant/adjuvant setting must progress within an year from the end of the treatment, while patients who received the drugs in the metastatic setting have not to be treated with more than one line chemotherapy for the advanced disease. Patients HER2 positive (IHC 3+ or FISH positive) must have received trastuzumab in the adjuvant and/or metastatic setting and must have discontinued therapy prior to enrolling on study. Adequate recovery from prior systemic therapy. At least 2 weeks must have elapsed since last hormonal therapy and at least 3 weeks must have elapsed from the last dose of all other systemic therapy, including investigational treatment. Adequate recovery from recent surgery and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery and radiation therapy. Life expectancy of at least 12 weeks. Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating centers. Patients can receive bifosfonates if they have started this therapy before the randomization in the study. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. Give written informed consent
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

Exclusion Criteria

Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study or using a prohibited contraceptive method. Women who are pregnant or breast feeding or with a positive pregnancy test on enrollment or prior to study drug administration. Any history of brain metastases and/or leptomeningeal metastases. Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the protocol. Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with a history of previous malignancies but without evidence of disease for ≥5 years will be allowed to enter the trial. Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy. Myocardial infarction, unstable angina or unstable congestive heart failure within six months. Patients treated with Warfarin that are not able to receive Heparin during the chemotherapy period Known history of HIV infection. Inability to take and/or absorb oral medication including previous gastric surgery, or any evidence of partial esophageal, gastric, small or large bowel obstruction. Hematologic function with absolute neutrophils count <1.000/mm3 and/or platelets count < 100.000/mm3. Hepatic function with serum bilirubin >1.5 the upper institutional limits of normal (UNL), ALT or AST >2.5 times UNL (for all patients, regardless of the presence of hepatic metastases) or ALP > 3 times UNL (unless patients have hepatic disease, in which case ALP can reach 5 times UNL) Adeguate renal function (creatinine clearance < 40 ml/h) Other concurrent chemotherapy or radiation therapy regimens, standard or investigational. Prior treatment with navelbine and/or with fluoropirimidine administered as oral formulation or endovenous continous infusion Prior history of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within two years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified