Chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus Kisqali® (ribociclib) in patients with HER2 positive and hormone-receptor positive metastatic breast cancer.
Especially for diseases that are not curable such as metastatic breast cancer (MBC), the maintenance of quality of life is one of the main aims of treatments. Adverse events are well-known side effects of any cytostatic treatment and impact the patients' quality of life. Therefore, new treatment options are developed that should stop or at least slow down metastatic spread of cancer without causing negative side effects in terms of high-grade adverse events. For patients with hormone-receptor positive and HER2 positive MBC the combination of HER2-targeted therapy with endocrine therapy has already been proven to be an effective and in many cases valuable alternative to the combination of HER2-targeted therapy with chemotherapy. The high relevance of HER2-neu-targeted/endocrine treatment combinations derives from the fact that potential chemotherapy-related toxicity can be avoided, which in turn positively affects quality of life. Clinical trials suggest an additional benefit when a CDK4/6 inhibitor is added to the combination of endocrine therapy and anti HER2 treatment. DETECT V is a randomized phase III study comparing the safety and efficacy of trastuzumab plus pertuzumab and the CDK 4/6 inhibitor ribociclib in combination with either endocrine therapy or chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
271
University Hospital Ulm Gynecology/Obstetrics
Ulm, Germany
Number of Participants with Adverse Events
safety of a dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (riobciclib) plus endocrine therapy as compared to a dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus chemotherapy (followed by endocrine therapy plus ribociclib in combination with trastuzumab and pertuzumab as maintenance therapy) by the proportion of patients experiencing any adverse event (as defined by the modified adverse event score)
Time frame: 3 - 9 weeks
quality-adjusted survival
to assess quality-adjusted survival (as assessed by the Q-TWiST method) and to compare it between the two treatment arms
Time frame: 3 - 9 weeks
overall response rate (ORR)
compare efficacy between the two treatment arms as assessed by overall response rate (ORR)
Time frame: 3 - 9 weeks
incidence of central nervous system (CNS) metastases and their control rate
assess the incidence of CNS metastases and control rate of preexisting CNS metastases
Time frame: 3 - 9 weeks
Analysis of Quality of life
assess additional aspects of quality of life based on the evaluation of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) QLQ-C30 and QLQ-BR23 questionnaires
Time frame: 3 - 9 weeks
presence and number of circulating tumor cell (CTC) at different time points
determine presence and number of CTC in the peripheral blood at baseline and at different time points after the start of palliative treatment including the time of progression, and to assess the value of CTCs as indicator for therapy success
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chemotherapy
Chemotherapy
Chemotherapy
endocrine therapy
endocrine therapy
endocrine therapy
endocrine therapy
CDK 4/6 inhibitor
chemotherapy
chemotherapy
endocrine therapy
endocrine therapy
Time frame: 6 weeks
Evaluation of all reported events and all grades in both treatment arms (chemotherapy and endocrine therapy)
All reported events with all grades for evaluation of safety and tolerability of the study treatments and to to evaluate and compare toxicity of chemotherapy arm vs. endocrine treatment arm
Time frame: 3 - 9 weeks
disease control rate (DCR)
compare efficacy between the two treatment arms as assessed by disease control rate (DCR)
Time frame: 3 - 9 weeks
progression-free survival (PFS)
compare efficacy between the two treatment arms as assessed by progression-free survival (PFS)
Time frame: 3 - 9 weeks
overall survival (OS)
compare efficacy between the two treatment arms as assessed by overall survival (OS)
Time frame: 3 - 9 weeks