Project

SAKK 21/18 Ribociclib-endocrine combination therapy versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer. A mul-ticenter, randomized phase III trial

Ongoing - recruitment active · 2019 until 2026

Type
Clinical Studies
Range
Multicentric, KSSG as main centre
Units
Status
Ongoing - recruitment active
Start Date
2019
End Date
2026
Financing
SAKK
Study Design
Phase III
Keywords
Ribociclib-endocrine combination therapy, visceral meta-static breast cancer
Homepage
Brief description/objective

Breast cancer is the most frequent malignancy in women and the
leading cause of cancer mortality in most countries in Europe.
Metastatic breast cancer remains an incurable disease with a
median overall survival (OS) of 2–4 years and a 5 year survival
of only 25%. Patients with hormone receptor (HR)-positive breast cancer involving visceral disease at diagnosis have an even worse
outcome.
Many oncologists still prefer to treat visceral diseases primarily with chemotherapy rather than with endocrine
treatment, thinking to receive a faster response with chemothera-py than with endocrine therapy, especially in patients with clinical
symptoms or potentially threatening lesions. However,
results from cross-sectional clinical practice studies suggest
that endocrine therapy is associated with better quality of life,
fewer concerns about side effects, less activity impairment and
higher treatment satisfaction compared to chemotherapy. In addition,
with the new data of CDK4/6 inhibitors combined with endocrine
treatment we now have even better efficacy data compared to
endocrine therapy alone.