OncoMatch/Clinical Trials/NCT07463235
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Is NCT07463235 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07463235 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require PRL?
Yes, PRL hyperprolactinemia (prolactin ≥2x ULN) is a required biomarker for enrollment.
Are patients with IGF1 alterations eligible?
No. IGF1 overexpression (IGF-1 >1x ULNR) is an exclusion criterion.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify