Phase II study of irinotecan weekly in combination with trastuzumab in patientswith locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1”

Conditions: Metastatic breast cancer
MedDRA version: 17.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-002347-23-DK

Lead Sponsor: Danish Breast Cancer Group (DBCG)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

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 positive 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
Baseline LVEF = 50% measured by echocardiography or MUGA

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

Exclusion Criteria

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.
Dyspnoea when resting due to complications of progressive malignancy (metastasis of the lung with lymphangitis) or other conditions requiring oxygen therpy.