Hormone Receptor positive postmenopausal breast cancer
Conditions
Brief summary
The primary endpoint is the mean change in log-transformed KI67 expression values between baseline and time of surgery in the different arms.
Detailed description
Adherence to GLP1/GIP RA and letrozole treatment, The type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v6.0), seriousness, time till onset and duration of Adverse Events (AEs)/SAEs and any laboratory abnormalities., Perioperative complications graded using the Clavien Dindo Classification (Dindo et al, 2004, Ann Surg) up till 3 weeks postoperative., To evaluate the presence of circulating tumor DNA (ctDNA) at baseline, during treatment and at surgery in plasma samples. To evaluate changes between baseline, during treatment and at surgery in plasma samples
Interventions
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the mean change in log-transformed KI67 expression values between baseline and time of surgery in the different arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to GLP1/GIP RA and letrozole treatment, The type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v6.0), seriousness, time till onset and duration of Adverse Events (AEs)/SAEs and any laboratory abnormalities., Perioperative complications graded using the Clavien Dindo Classification (Dindo et al, 2004, Ann Surg) up till 3 weeks postoperative., To evaluate the presence of circulating tumor DNA (ctDNA) at baseline, during treatment and at surgery in plasma samples. To evaluate changes between baseline, during treatment and at surgery in plasma samples | — |
Outcome results
None listed