Breast cancer study

• Conditions: Her-2 negative metastatic or locally advanced inoperable breast cancer; MedDRA version: 17.0Level: 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: EUCTR2009-018025-73-DE
• Lead Sponsor: GMIHO mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-31
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

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

Inclusion Criteria

1.Histologically or cytologically confirmed adenocarcinoma of the breast
2.HER-2/neu negative (primary tumour site HER-2/neu negative by ICH/FISH test)
3.Second till third-line of cytostatics based chemotherapy
4.Female, age = 18 years.
5.ECOG Performance Status of 0 or 1 (Karnofsky-Index = 70%)
6.Life expectancy of at least 12 weeks.
7.Subjects with at least one uni-dimensional (for RECIST 1.1) measurable lesion.
Lesions must be measured by Xray (pulmonary lesions only) or CT-scan or MRI (Patients with only measurable bone lesions can be also included, as long they meet the criteria for RECIST 1.1. Means, lytic bone lesions or mixed lytic-blastic bone lesions with identifiable soft tissue components.)
8.No prior therapy for locally recurrent or metastatic disease with TKI’s (RAS/Raf, MEK, AKT), mTOR inhibitors and angiogenesis inhibitors (VEGV/VEGFR, PDGF/PDGFR) but bevacizumab will be allowed.
9.Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Hemoglobin = 9.0 g/dl
Absolute neutrophil count (ANC) = 1,500/mm3
Platelet count = 100,000/µl
Total bilirubin = 1.5 x upper limit of normal
ALT and AST = 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
Alkaline phosphatase = 4 x upper limit of normal
PT-INR and PTT = 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
Serum creatinine = 1.5 x upper limit of normal.
10.Signed and dated informed consent before the start of specific protocol procedures.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 148

Exclusion Criteria

1.History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
2.Known history of HIV infection or chronic hepatitis B or C
3.Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
4.Prior clinical or radiological evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by contrast enhanced head CT scan or MRI
5.Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
6.History of organ allograft
7.Patients with evidence or history of bleeding diathesis
8.Patients undergoing renal dialysis
9.Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
10.Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
11.Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
12.Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study
13.Patients unable to swallow oral medications.
14. Patients with intolerance to Paclitaxel

Study & Design

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