OncoMatch/Clinical Trials/NCT07463235
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Is NCT07463235 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cabergoline and Cabergoline for prolactinoma.
Treatment: Cabergoline · Cabergoline — This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of \~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PRL hyperprolactinemia (prolactin ≥2x ULN) (≥2x upper limit of normal)
Hyperprolactinemia, defined as a prolactin (PRL) level ≥2 times the local laboratory maximum level of normality, present at the time of enrolment
Excluded: IGF1 overexpression (IGF-1 >1x ULNR)
IGF-1 level above the age-adjusted normal range of the local laboratory (IGF 1 >1x ULNR)
Prior therapy
Cannot have received: radiation therapy
Prior radiotherapy of the pituitary gland area for any reason
Cannot have received: pituitary tumor-directed therapy (temozolomide, everolimus, lapatinib, cytotoxic chemotherapy)
Additional pituitary tumor-directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy
Lab requirements
Kidney function
estimated glomerular filtration rate ≥30 mL/min /1.73m2
Liver function
AST/TGO or ALT/TGP ≤3x upper limit of normality
Renal failure (estimated glomerular filtration rate <30 mL/min /1.73m2) [excluded]; Hepatopathy with AST/TGO or ALT/TGP >3x the upper limit of normality [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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