CAREGIVER
Cyclin dEpendent kinase in tRiple nEGatIVe brEast canceR – a “window of opportunity” study
About the study
CAREGIVER was a prospective, randomised, multicentre, open-label, five-arm clinical trial designed to evaluate the clinical and biological effects of palbociclib combined with chemotherapy in patients with triple-negative breast cancer (TNBC).
The study followed a “window of opportunity” design, allowing researchers to assess early treatment responses and biological changes before definitive treatment.
What is triple-negative breast cancer?
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer characterised by the absence of oestrogen receptors, progesterone receptors and HER2 overexpression.
Because TNBC lacks these common therapeutic targets, treatment options are more limited and often rely primarily on chemotherapy.
Study design
Eligible patients with previously untreated TNBC underwent a pre-screening phase, during which a breast tumour biopsy was performed to confirm diagnosis, identify TNBC cases and collect tissue samples for translational research.
The study was designed as a prospective, randomised, multicentre, open-label, five-arm trial with unequal allocation ratios of 1:1:2:1:2.
Primary endpoint
The primary endpoint was the difference in early metabolic response after three weeks of treatment (one treatment cycle) in chemotherapy-containing study arms (chemotherapy ± palbociclib).
Response was assessed through blinded central review by comparing reductions in SUVmax between baseline and Day 27 (±3 days) using 18F-FDG PET-CT imaging.
The primary analysis compared chemotherapy combined with palbociclib versus chemotherapy alone.
Study objectives
Primary efficacy objective
- to evaluate early clinical efficacy parameters of chemotherapy combined with palbociclib compared with chemotherapy alone in triple-negative breast cancer.
Secondary and exploratory efficacy objectives
- to investigate the clinical efficacy and biological effects of chemotherapy combined with palbociclib, including changes in gene and protein expression, morphological changes and pathological tumour regression, compared with chemotherapy alone or palbociclib monotherapy.
Safety objective
- to evaluate the safety of chemotherapy combined with palbociclib compared with chemotherapy alone.
Study population
The study was planned to enrol 126 adult women and men aged over 18 years with triple-negative breast cancer.
Participating centres
CAREGIVER was conducted as a partnership project involving leading oncology centres in Poland.
Gdańsk
Medical University of Gdańsk
National Coordinating Investigator:
Elżbieta Senkus-Konefka, MD, PhD, Professor
Elżbieta Senkus-Konefka, MD, PhD, Professor
Wrocław
Lower Silesian Oncology Centre
Principal Investigator:
Aleksandra Łacko, MD, PhD
Aleksandra Łacko, MD, PhD
Gliwice
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Principal Investigator:
Michał Jarząb, MD, PhD, Professor
Michał Jarząb, MD, PhD, Professor
Organisational information
The project was funded by the Polish state budget through the Medical Research Agency (MRA) under the non-commercial clinical trials funding call ABM/2020/1.
Project number: 2020/ABM/01/00008.
Project duration: 01 December 2020 – 30 November 2026.
Funding and total project value: PLN 17,435,785.00.
Key information
project number
2020/ABM/01/00008
funding call
ABM/2020/1
funding
PLN 17,435,785.00
total project value
PLN 17,435,785.00
project duration
01 December 2020 – 30 November 2026
status
study closed
study type
prospective, randomised, multicentre, open-label, five-arm clinical trial
national coordinating investigator
Elżbieta Senkus-Konefka, MD, PhD, Professor