Table of contents
- Clinical trial overview
- Breast cancer studies
- Prostate cancer studies
- Fertility and ovarian stimulation studies
- Main endpoints measured in the trials
- Who the trials are designed for
Clinical trial overview
The trial data show that Triptorelin Acetate is being studied in different research settings, mainly in breast cancer, prostate cancer, and fertility care.[1][2][3][4][5][6][7][8][9]
Most of the listed studies are Phase 2 or Phase 3 interventional trials, which means they are testing treatment strategies and comparing results across groups.[1][2][3][4][5][6][7][8][9]
Breast cancer studies
One Phase 2 study is in premenopausal women with early luminal breast cancer and looks at elacestrant with or without Triptorelin Acetate, with tamoxifen as another treatment option in the study design.[5]
The main endpoint in that study is the rate of CCCA, measured by Ki67 testing in central review, after short-term treatment.[5] Ki67 is a marker that shows how fast cancer cells are growing.[5]
Another Phase 3 study includes patients with ER-positive/HER2-negative, ESR1-mutated advanced breast cancer and compares elacestrant plus everolimus with elacestrant plus placebo.[8] Triptorelin is listed among the study interventions in this trial, along with other hormone-related treatments.[8]
The main endpoint in this study is progression-free survival, which means the time before the cancer gets worse or the patient dies from any cause.[8]
Prostate cancer studies
Several trials study Triptorelin Acetate in prostate cancer, including newly diagnosed disease, metastatic disease, and hormone-naïve disease.[2][3][6][7]
In a Phase 3 trial in newly diagnosed prostate cancer with pelvic lymph node metastases, Triptorelin is one of the hormone therapy options used with radiotherapy and darolutamide.[7] The main endpoint is failure-free survival, which measures the time until the cancer shows clinical, blood test, or imaging signs of worsening, or until death or follow-up ends.[7]
In another Phase 3 study in metastatic hormone-sensitive prostate cancer, Triptorelin appears among the standard hormone treatment options while the trial tests whether adding 177Lu-PSMA-617 improves outcomes.[2] The main endpoint is radiographic progression-free survival, which is the time before scans show the cancer has grown or spread, or before death.[2]
A Phase 3 study in metastatic hormone naïve prostate cancer compares intermittent maximum androgen blockade with continuous treatment, and Triptorelin is one of the listed hormone therapies.[3] The co-primary endpoints are the proportion of patients who do not restart hormonal therapy within 1 year and overall survival.[3]
A Phase 2 study in hormone naïve prostate cancer compares darolutamide with androgen deprivation therapy, and Triptorelin and Triptorelin pamoate are among the hormone treatment options listed.[6] The main endpoint is PSA response at 24 weeks, defined as at least an 80% drop in PSA from baseline.[6]
Another Phase 3 study in very high risk localized or locally advanced prostate cancer tests radiotherapy with different hormone treatment choices, including Triptorelin.[9] The main endpoint is the proportion of patients with PSA nadir below 0.1 ng/mL within 6 months after radiotherapy.[9]
Fertility and ovarian stimulation studies
Some trials focus on fertility care in women, including assisted reproductive technology, elective egg freezing, and prevention of female infertility.[1][4][5]
One study in women undergoing ART such as IVF or ICSI compares different ovarian stimulation protocols and includes Decapeptyl among the listed study drugs.[1] The primary endpoint is the number of fertilised oocytes, measured as 2 pronuclei (2PN) oocytes about 19 hours after insemination.[1]
Another Phase 3 trial studies elective oocyte cryopreservation, which means freezing eggs for future use, and compares random-start ovarian stimulation with conventional early follicular phase stimulation.[4] The main endpoint is the total number of mature cryopreserved oocytes per stimulation cycle.[4]
A separate Phase 3 crossover study in subfertility compares two ovarian stimulation approaches in women undergoing fertility preservation or preimplantation genetic testing (PGT).[4] Its main endpoint is treatment-related quality of life and patient satisfaction measured by questionnaire at the end of each stimulation cycle.[4]
Main endpoints measured in the trials
The trial endpoints show what each study is trying to prove or measure.[1][2][3][4][5][6][7][8][9]
Cancer control endpoints include progression-free survival, failure-free survival, and overall survival, which track whether the disease stays stable or gets worse over time.[2][3][7][8]
PSA endpoints are used in prostate cancer studies and measure how much the PSA blood level falls after treatment.[6][9]
Fertility endpoints include fertilised oocytes, mature cryopreserved oocytes, and ovarian response, which help show how well the stimulation plan works for egg collection or freezing.[1][4]
Biology endpoints such as Ki67 and CCCA are used in breast cancer to study how the treatment affects cancer cell growth.[5]
Patient-reported outcomes like quality of life and satisfaction are measured in some fertility trials to understand the patient experience, not only the medical result.[4]
Who the trials are designed for
The studies are designed for different patient groups, so eligibility depends on the condition being studied.[1][2][3][4][5][6][7][8][9]
Premenopausal women are included in the breast cancer study because hormone-related treatment questions are being tested in this group.[5]
Men with prostate cancer are included across several trials, from hormone-naïve disease to metastatic disease and pelvic lymph node metastases.[2][3][6][7][9]
Women in fertility treatment are included in studies of IVF, ICSI, egg freezing, ovarian stimulation, and fertility preservation.[1][4]
