Table of Contents

• Trial overview
• Breast cancer studies
• Prostate cancer studies
• Fertility and reproductive studies
• Other studies
• Main endpoints being measured
• Who can participate

Trial overview

The trial data show that Triptorelin is being studied in several different settings, mainly breast cancer, prostate cancer, and fertility treatment.^[1][2] Most studies are Phase 2 or Phase 3 trials, which means they are testing how well the treatment works in larger patient groups and, in some studies, comparing it with other options.^[1][2] Several studies are authorised, some are completed, and one study in the source data is withdrawn.^[1]

Breast cancer studies

Many Triptorelin trials focus on women with ER-positive/HER2-negative or HR-positive/HER2-negative early breast cancer, including both premenopausal and high-risk groups.^[2][3] In these studies, Triptorelin is used with other endocrine treatments, and the trials aim to see whether the treatment plan lowers cancer growth, delays recurrence, or improves invasive breast cancer-free survival.^[2][3]

One Phase 2 study in premenopausal women with operable breast cancer compared giredestrant plus Triptorelin with anastrozole plus Triptorelin, and also looked at giredestrant without Triptorelin.^[2] Its main endpoint was the change in Ki-67, a marker that shows how fast tumor cells are growing, measured between a biopsy before treatment and a biopsy after treatment.^[2]

Large Phase 3 trials also study Triptorelin in early breast cancer, including studies of adjuvant endocrine-based therapy and personalized treatment strategies in young women.^[3][4] These trials measure outcomes such as IBCFS, which is the time until an invasive breast cancer event, a new cancer in the other breast, or death.^[3][4]

Another completed Phase 2 study in metastatic breast cancer compared alpelisib-fulvestrant with ribociclib-fulvestrant in patients with persistent PIK3CA mutations after early treatment with a CDK4/6 inhibitor and fulvestrant.^[5] Triptorelin was one of the hormone treatment options listed in that study, and the main endpoint was progression-free survival.^[5]

Prostate cancer studies

Triptorelin is also studied often in prostate cancer, including localised, locally advanced, recurrent, oligometastatic, and metastatic disease.^[6][7] These studies usually compare different hormone treatment strategies, sometimes together with radiotherapy, and they look at whether the cancer stays controlled for longer or whether the risk of metastasis is reduced.^[6][7]

In a Phase 3 study of very high-risk localised or locally advanced prostate cancer, Triptorelin was one of several GnRH agonists compared with other hormone options alongside radiotherapy.^[6] The main endpoint was the proportion of patients reaching a PSA nadir below 0.1 ng/mL within 6 months after radiotherapy, which means the lowest PSA level achieved after treatment.^[6]

Another Phase 3 study looked at patients with oligorecurrent hormone-sensitive prostate cancer and tested whether adding short-term hormone therapy, including Triptorelin, to metastasis-directed therapy could delay poly-metastatic progression.^[7] That study measured poly-metastatic free survival, which is the time until the disease spreads to more than five new lesions on imaging or until treatment changes because of progression.^[7]

Other prostate cancer trials included Triptorelin in studies of salvage radiotherapy after surgery, darolutamide with or without radiation, and treatment approaches for metastatic castration-sensitive or castration-resistant disease.^[8][9] These studies measure outcomes such as metastasis-free survival, radiographic progression-free survival, biochemical disease-free survival, and quality of life.^[8][9]

Fertility and reproductive studies

Several Triptorelin trials are in fertility care, especially ovarian stimulation, embryo development, and fertility preservation.^[10][11] These studies involve women undergoing IVF, ICSI, oocyte donation, or planned fertility preservation, and they compare different stimulation or triggering approaches.^[10][11]

In ovarian stimulation studies, the main outcomes often focus on the number of MII oocytes, which are mature egg cells, or the number of good-quality blastocysts, which are early embryos with good development.^[10][11] For example, one Phase 3 trial compared intranasal nafarelin with subcutaneous Triptorelin to trigger final oocyte maturation, and another study compared different stimulation intensities in women undergoing PGT-A with a PPOS protocol.^[10][11]

Other fertility trials looked at live birth, clinical pregnancy, or the number of cumulus-oocyte complexes, which are egg cells surrounded by supporting cells collected after stimulation.^[12][13] One study also examined whether a GnRH agonist before frozen embryo transfer improves pregnancy rates in patients with endometriosis and/or adenomyosis.^[12]

There is also a Phase 3 study in women with low ovarian reserve and androgen receptor polymorphism that tested whether pretreatment with transdermal testosterone increases the number of cumulus-oocyte complexes after ovarian stimulation.^[13] This study was withdrawn in the source data, but it still shows the type of fertility questions being studied alongside Triptorelin.^[13]

Other studies

Triptorelin appears in a Phase 2 menopause study that compared a GnRH analog, transdermal estrogen, transdermal testosterone, and placebo over 8 weeks in postmenopausal women.^[14] The main outcome was the change in bone remodeling, measured through bone markers from baseline to week 8.^[14]

Another study looked at the use of Triptorelin in a Phase 1/II metastatic breast cancer trial combining [177Lu]Lu-NeoB with capecitabine, where Triptorelin was one of several hormone-related treatment options listed in the source data.^[15] The Phase I part focused on safety, dose-limiting toxicities, and tolerability, while the Phase II part looked at tumor response, clinical benefit, time to response, duration of response, progression-free survival, and overall survival.^[15]

Main endpoints being measured

The trial data show a wide range of endpoints, depending on the condition being studied.^[1] In cancer trials, common endpoints include survival without recurrence, progression-free survival, metastasis-free survival, PSA response, and changes in tumor markers such as Ki-67.^[2][6][8]

In fertility trials, the main endpoints often include the number of mature eggs, embryo quality, pregnancy rate, and live birth.^[10][11][12] In menopause research, the outcome is linked to bone marker changes, which help show how bone is being broken down or rebuilt.^[14]

Who can participate

Participation depends on the study and the disease being treated.^[1] The source data include premenopausal women with early or metastatic breast cancer, men with prostate cancer at different stages, women undergoing IVF or oocyte donation, postmenopausal women, and patients with endometriosis or adenomyosis.^{[2][6][10][12]}

Many studies have extra entry rules, such as hormone receptor status in breast cancer, the number of metastases in prostate cancer, or ovarian reserve in fertility trials.^[3][7][13] This means the trials are aimed at specific patient groups, not at everyone who uses Triptorelin in routine care.^[1]