.A phase ll trial of combination chemotherapy with intravenous oxaliplatin combined with tablet capecitabin in patients with recidivant breastcancer

• Conditions: breastcancer with metastases; MedDRA version: 16.0Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005329-56-DK
• Lead Sponsor: Dept of oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Informed concent Age > 18 years
Performance status 0-1; expected survival > 3 months
Prior treatment with a Taxane and antracyclin
No treatment with capecitabine and oxaliplatin
Evaluable disease (recist 1.1)
neu granulocytes > 1,5, thrombocytes >100
bilirubine <2 x UNL
Creatinine-clearence >30 ml/min
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• History of chemotherapy within the 4-week period prior to the start of
trial medication
• Other current or prior malignant disease except adequately treated
and cured carcinoma in situ of the cervix or squamous cell carcinoma of
the skin
• Previous treatment with oxaliplatin
• Cytotoxic or experimental treatment within a 14 days period before
start of trial medication
• Current participation in other clinical trials
• Any clinical symptoms suggesting peripheral neuropathy grade 2 or
CNS metastases (In case of clinical suspicion on CNS metastases a MR or
CT scan must be conducted within 4 weeks before inclusion)
• Other severe medical conditions e.g. severe cardiovascular disease or
AMI < 1 year
• Medical diseases or condition affecting the patients compliance with
peroral study drug
• Patients with uncontrolled infection
• Pregnant or lactating women
• Women capable of childbearing not using a sufficient non-hormonal
method of birth control (spiral)
• Patients who due to physiological, intelectual, cultural reasons, or
lack of language capabilities, an unable to comply with the treatment
concept or to place the patient at high risk from treatment related
complications
• Prior serious or unsuspected reaction to fluorpyrimidin therapy
• Known prior hypersensitivity reactions any components used

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Response rate<br>Number of patients with complete or partial respons (Recist 1.1);Secondary Objective: Time to<br>a) Progression<br>b) Survival<br>c) Toxicity;Primary end point(s): Response rate<br>Number of patients with complete or partial response.<br>(RECIST version 1.1);Timepoint(s) of evaluation of this end point: After 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to progression<br>Toxicity<br>Overall survival;Timepoint(s) of evaluation of this end point: TTP: from first study drug administration to progression or death<br>Survival:from first study drug administration to death of any cause <br>Toxicity: at every clinical control