Metastatic breast cancer MedDRA version: 17.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Herceptin
Product Name: trastuzumab
Product Code: NA
Pharmaceutical Form: Infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Danish Breast Cancer Group (DBCG)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, overall survival and 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival Toxicity Overall Survival;Timepoint(s) of evaluation of this end point: PFS: from first study drug administration to progression or death Overall Survivial: from first study drug administration til death of any cause Toxicity: at every clinical control | — |
Countries
Denmark
Contacts
Public ContactDep. of Oncology
Herlev Hospital
Outcome results
None listed