Clinical study of irinotecan weekly in patients with locally advanced or metastatic HER2-negative breast cancer and increased cancer cell copy number of the topoisomerase 1 gene”
- Conditions
- Metastatic breast cancerMedDRA version: 17.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002348-26-DK
- Lead Sponsor
- Danish Breast Cancer Group (BDCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- 40
Histological or cytological confirmed adenocarcinoma of the breast
MBC with = 4 TOP1 genes in the primary tumour.
Age › 18
Performance status 0-2
Locally advanced or metastatic disease
HER2 negative disease
Measurable disease by RECIST 1.1
Maximum 4 prior chemotherapy regiments for locally advanced or metastatic disease
Neutrophil count (ANC) = 1,5 x 10?/l and platelet count = 100 x 10?/l
Serum bilirubin = 1.5 x ULN
Serum transaminases = 2.5 x ULN
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Other present or previous malignancy except curatively treated
cervical cancer stage I or non-melanotic skin cancer
Cytotoxic or experimental treatment 2 weeks prior to inclusion
Pregnant or breast-feeding. For fertile women a negative pregnancy
test at screening is mandatory.
Fertile patients not willing to use IUD as an acceptable and safe method of
contraception
CNS metastasis
Allergy to the ingredients of the study medication.
Patients who due to linguistic, culturel or incelectual reasons do not understand the protocol information
Any condition or therapy that in the opinion of the investigator will put the patient at risk
Patients with ongoing infections or other serious concomitant medical conditions that could interfere with the treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1;Secondary Objective: Progression free survival<br>Overall survival <br>toxicity.;Primary end point(s): Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Every 6 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression free survival<br>Overall survival <br>toxicity.;Timepoint(s) of evaluation of this end point: PFS: from first treatment date to progression or death<br>Overall Survival: from first treatment date to death of any cause<br>Toxicity: at every clinical control