HER2-positive early breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Current interventions as of 08/10/2014:
Patients will receive during or after a standard regimen of chemotherapy either:
1. The standard treatment, i.e. a dose every 3
Sponsors
Cambridge Hospitals NHS Foundation Trust and Cambridge University (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of invasive breast cancer 2. No evidence of metastatic disease 3. Known hormone receptor status 4. Overexpression of HER-2 positive: 3+ overexpression by immunohistochemistry (IHC) or 2+ overexpression by IHC and fluorescence in situ hybridisation (FISH) test positive 5. Clear indication for chemotherapy based on clinical and histopathological features 6. Patient fit to receive any of the trial chemotherapy regimens 7. Patient must not have clinically significant cardiac abnormalities and must not have had a previous myocardial infarction during the 6 months prior to recruitment. Cardiac function should be assessed by physical examination and electrocardiogram (ECG) 8. Patient must have adequate bone marrow, hepatic, and renal function 9. No previous chemotherapy or radiotherapy 10. No previous diagnosis of malignancy unless: 10.1. Managed by surgical treatment only, and disease-free for 10 years 10.2. Previous basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast treated by surgery only 11. Non-pregnant and non-lactating 12. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up 13. Patients 18 years or older (updated 08/10/2014; originally women only) 14. Written informed consent for the study
Exclusion criteria
Exclusion criteria: 1. Non-controlled or malignant arterial high-pressure 2. Clinically significant cardiac disease. Cardiac left ventricular ejection fraction below normal range 3. History of atrio-ventricular arrhythmias and/or congestive heart failure, even where it is under medical control, or active second- or third-degree cardiac block. History of myocardial infarct during the 6 months prior to recruitment. 4. Any co-morbidity significantly adding to risks associated with cytotoxic chemotherapy, for instance: severe chronic obstructive pulmonary disease, poorly controlled diabetes, etc. 5. History of allergy to drugs containing polysorbate 20 and the excipient TWEEN 80® and history of allergy to mouse proteins 6. Inability to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Does 6 months of trastuzumab treatment prevent breast cancer death as well as 12 months of trastuzumab treatment? 2. What is the health economic costs and the quality of life for patients receiving 6 months versus 12 months of trastuzumab treatment? Research will also be conducted through the collection of tissue samples Updated 08/10/2014: Research will also be conducted through the collection of blood and tissue samples | — |
Countries
United Kingdom
Outcome results
None listed