Mammary carcinoma
Conditions
Interventions
Palbociclib, ribociclib or abemaciclib
Sponsors
BOOG study center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated. 2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer based on local laboratory results. 3. Previously untreated with any systemic anti-cancer therapy for loco-regional recurrent or metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine treatment. Evaluable disease according to RECIST is sufficient for inclusion (also patients with no target lesions, other than bone only disease, are allowed to participate). If patients have already started palliative endocrine therapy (<21 days before randomization), they may still be included.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term. 2. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. 3. Prior neoadjuvant or adjuvant treatment with an aromatase inhibitor with disease recurrence while on or within 12 months of treatment. 4. Prior treatment with any CDK4/6 inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival after two lines of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival - Objective response - Quality of life - Cost-effectiveness - Adverse events | — |
Contacts
Public ContactElise van Leeuwen-Stok
Postbus 9236
Outcome results
None listed