Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients. The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Trastuzumab: loading dose of 8 mg/kg of body weight on cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks. Pertuzumab: loading dose of 840 mg on cycle 1, followed by 420 mg for subsequent cycles, every 3 weeks. if T-DM1: 3.6 mg/kg IV, every 3 weeks.
Pertuzumab and trastuzumab will be administered as in arm A. Cyclophosphamide: daily dose of 50 mg/day. if T-DM1: as in arm A
UZ Antwerpen
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Hopital De Jolimont
Haine-Saint-Paul, Belgium
AZ Groeninge Kortrijk
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
Progression free survival rate
Time frame: 6 months after patients in
Overall survival
Breast cancer specific survival
Tumor response rate as measured by RECIST v1.1
Evolution of HRQoL as assessed by EORTC QLQ-C30 and ELD 14
Time frame: Up to 1 year after treatment start
Evolution of geriatric assessment
Time frame: Up to 1 year after treatment start
if T-DM1: progression free survival rate
Time frame: 6 months after start of T-DM1 treatment
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CHU Sart-Tilman
Liège, Belgium
Clinique et Maternité Sainte Elisabeth
Namur, Belgium
AZ Damiaan
Ostend, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
...and 20 more locations