Table of Contents
- Clinical trial overview
- Breast cancer studies
- Prostate cancer studies
- What the trials measure
- Who may join these studies
- Trial phases and study size
- Key terms explained
Clinical trial overview
These studies are looking at Goserelin in cancer research, mainly in breast cancer and prostate cancer.[1] Most of the trials are interventional, which means the study team assigns treatments and compares results.[1]
Many of the trials are in Phase 3, with some in Phase 2 and Phase 1/2, so the research includes both larger comparison studies and earlier safety-focused studies.[1] In several studies, Goserelin is used together with endocrine therapy, chemotherapy, targeted therapy, or radiotherapy.[1]
Breast cancer studies
Several trials study Goserelin in early breast cancer, especially in patients with hormone receptor-positive and HER2-negative disease.[1] One large Phase 3 study in premenopausal patients with high-risk disease is testing a gene-expression-driven strategy to decide whether adjuvant chemotherapy is needed, and it measures invasive breast cancer-free survival.[1]
Other breast cancer trials look at Goserelin in adjuvant treatment, which means treatment given after the main cancer treatment to lower the risk of return.[1] These studies measure outcomes such as invasive breast cancer-free survival, invasive disease-free survival, and recurrence prevention.[1]
Goserelin also appears in studies for advanced and metastatic breast cancer, including patients with PIK3CA mutations or patients who have already received endocrine therapy and CDK4/6 inhibitor treatment.[1] In these trials, researchers measure progression-free survival, disease control, and anti-tumor activity.[1]
One Phase 3 study looks at hot flashes in women using endocrine therapy after breast cancer and compares symptom treatment strategies.[1] In this study, the main endpoint is the number and severity of hot flashes during 6 weeks, measured with a daily diary.[1]
Prostate cancer studies
Goserelin is also studied in prostate cancer, including castrate-resistant prostate cancer, very high-risk localized or locally advanced prostate cancer, and metastatic hormone-sensitive prostate cancer with high tumor load.[1] These trials test Goserelin in combination with radiotherapy or other treatment plans.[1]
One Phase 3 study in castrate-resistant prostate cancer compares stereotactic body radiation therapy plus darolutamide with darolutamide alone and measures radiographic progression-free survival.[1] Another Phase 2 study uses Goserelin with personalized radiotherapy and measures 5-year disease-free survival.[1]
In a Phase 3 study of very high-risk localized or locally advanced prostate cancer, researchers are measuring the proportion of patients who reach a PSA nadir below 0.1 ng/mL within 6 months after radiotherapy.[1] A different Phase 3 prostate cancer study compares treatment approaches and measures radiological progression-free survival and overall survival.[1]
What the trials measure
The main outcomes in these studies are mostly cancer control measures.[1] Common endpoints include invasive breast cancer-free survival, progression-free survival, disease-free survival, and overall survival.[1]
Some studies also measure how well treatment is tolerated, including safety events, dose changes, and treatment interruptions.[1] Symptom-focused trials may measure hot flashes or quality of life related to endocrine therapy symptoms.[1]
Who may join these studies
Eligibility depends on the specific trial, but the source data show several main groups.[1] These include premenopausal women with high-risk early breast cancer, adults with advanced or metastatic breast cancer, and men with different stages of prostate cancer.[1]
Some breast cancer studies require hormone receptor-positive and HER2-negative disease, while others focus on HER2-positive disease or patients with a PIK3CA mutation.[1] Prostate cancer studies may require castrate-resistant disease, localized high-risk disease, or metastatic hormone-sensitive disease with high tumor load.[1]
Trial phases and study size
The largest part of the Goserelin trial set is in Phase 3, which usually means a later-stage study comparing how well different treatment strategies work in larger groups.[1] The source data also include Phase 2 studies and one Phase 1/2 study, which are earlier stages and often focus more on safety and early signs of benefit.[1]
Enrollment ranges from very small studies with only a few patients to very large studies with several thousand participants.[1] This wide range shows that Goserelin is being studied in both exploratory research and large confirmatory trials.[1]
Key terms explained
Adjuvant treatment means treatment given after the main therapy to help reduce the risk that cancer returns.[1] Endocrine therapy is treatment that targets hormone-related cancer growth, and it appears often in the breast cancer studies.[1]
Radiographic progression-free survival means the time before scans show the cancer is getting worse.[1] PSA stands for prostate-specific antigen, a blood marker used in prostate cancer studies, and a PSA nadir is the lowest PSA level reached after treatment.[1]
Hot flashes are sudden feelings of heat, and in the RED FLASH study they are measured with a daily diary during 6 weeks of therapy.[1] RECIST is a standard way to measure how tumors change on scans in cancer trials.[1]
