Table of Contents

• Trial overview
• Breast cancer studies
• Prostate cancer studies
• Other cancer studies
• Trial phases and safety measures
• Main endpoints used in the trials

Trial overview

The clinical trials in this set study Goserelin Acetate in cancer care, mainly in breast cancer and prostate cancer.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

Most of the studies are interventional trials, meaning the research team assigns a treatment plan and then measures what happens.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

The studies include different stages, from early research in Phase 1/2 to larger confirmatory studies in Phase 3 and follow-up research in Phase 4.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

Breast cancer studies

Several trials focus on ER-positive, HER2-negative advanced breast cancer, which is a breast cancer type that grows in response to estrogen and does not overexpress HER2, a growth-related protein.^{[2][5][9][10][12][14]}

One Phase 3 study compares AZD9833 plus palbociclib with anastrozole plus palbociclib in people who have not received systemic treatment for advanced disease, and it measures progression-free survival as the main outcome.^[2]

Another Phase 3 trial studies AZD9833 plus a CDK4/6 inhibitor in patients with metastatic breast cancer and a detectable ESR1 mutation, which means a change in a gene linked to hormone treatment resistance.^[9]

A Phase 3 study of OP-1250, also called Palazestrant, includes patients with ER+, HER2- metastatic breast cancer after endocrine therapy and CDK4/6 inhibitor treatment, and it compares safety and PFS against standard care.^[5]

In the ADELA study, elacestrant plus everolimus is compared with elacestrant plus placebo in patients with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer, and the main endpoint is PFS assessed by blinded imaging review.^[12]

Another Phase 2 study looks at durvalumab, olaparib, and fulvestrant in selected metastatic or locally advanced breast cancer patients with BRCA or other DNA repair changes, or MSI status, and it measures the progression-free survival rate at 24 weeks.^[10]

One Phase 3 maintenance study includes HR+, HER2- advanced or metastatic breast cancer and tracks long-term safety and clinical benefit while patients remain on ribociclib-based treatment.^[4]

Prostate cancer studies

Many of the trials study prostate cancer in different settings, including hormone-naive disease, low-volume metastatic castration-sensitive disease, recurrent disease after surgery, and oligorecurrent disease with a small number of metastases.^{[3][6][7][8][11][13][14]}

In one Phase 2 study, darolutamide is compared with androgen deprivation therapy in hormone-naive prostate cancer, and the main outcome is PSA response at 24 weeks.^[6]

Another Phase 2 study asks whether short-term darolutamide with radiation therapy can give a strong biological response in men with unfavorable intermediate-risk prostate cancer, using PSA of 0.1 ng/ml or less at 6 months as the endpoint.^[13]

A Phase 3 trial studies whether stopping androgen receptor signalling therapy after 12 months in low-volume metastatic castration-sensitive prostate cancer is non-inferior, meaning not worse than, continuing treatment, and it looks at time to clinical progression-free survival.^[3]

Another large Phase 3 study compares long-term versus short-term androgen deprivation therapy with salvage radiotherapy after prostatectomy, and it measures 5-year distant metastasis-free survival.^[11]

The THUNDER trial is a two-part Phase 2/3 study in prostate cancer that uses imaging-guided treatment choices and measures PSMA PET metastatic progression, health-related quality of life, and other survival outcomes.^[7]

In the oligorecurrent hormone-sensitive prostate cancer trial, researchers study whether metastasis-directed therapy with or without short-term hormone therapy can delay poly-progression, which means the spread of more than five new lesions.^[8]

The ARASAFE study compares two docetaxel schedules with Darolutamide plus ADT in metastatic hormone-sensitive prostate cancer and focuses on the rate of high-grade adverse events and neutropenia.^[14]

Other cancer studies

Not all trials are in breast or prostate cancer. One Phase 1/2 study includes selected advanced or metastatic solid tumors, with specific groups such as ER+ HER2- advanced breast cancer and high-grade serious ovarian cancer, and it focuses on safety, tolerability, dose-limiting toxicities, and the recommended Phase II dose.^[1]

A Phase 4 trial studies recurrent or metastatic salivary duct carcinoma and measures overall response rate and duration of response.^[13]

Trial phases and safety measures

Safety is a major part of the research in these studies, especially in the early-phase trial of AZD8421 and in the OP-1250 study, where researchers track adverse events, serious adverse events, laboratory tests, ECGs, and vital signs.^[1][5]

The Phase 1/2 trial also looks for dose-limiting toxicities, which are side effects severe enough to help define the highest dose that can be studied safely.^[1]

Some studies use randomized designs, meaning participants are assigned by chance to different treatment groups so the results can be compared fairly.^{[2][3][6][7][8][9][10][11][12][13][14]}

Some studies are double-blind, which means neither the participant nor the study team knows which treatment is being given during the trial period.^[2][9][12]

Main endpoints used in the trials

The trials use different endpoints, which are the main results the researchers want to measure.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

• Progression-free survival: time until cancer gets worse or the patient dies, used in several breast cancer trials.^{[2][5][9][10][12]}
• PSA response: a fall in prostate-specific antigen, used in prostate cancer trials to show treatment effect.^[6][13]
• Overall response rate: the share of patients whose tumors shrink or disappear on imaging, used in salivary duct carcinoma.^[13]
• Quality of life: how patients feel and function during treatment, measured in some prostate cancer studies.^[7][13]
• Safety outcomes: adverse events, serious adverse events, lab changes, ECG changes, and treatment stops because of toxicity.^[1][5][14]