goserelin acetate / Generic mfg. - LARVOL DELTA

Explosive Early Relapse of ER+/HER2− Breast Cancer Complicated by Tumor Lysis Syndrome and Severe Thrombocytopenia (ESMO Asia 2025) - "She received neoadjuvant doxorubicin–cyclophosphamide followed by paclitaxel, then underwent wide excision with axillary dissection, yielding ypT2N1 grade III disease with lymphovascular invasion. She completed adjuvant radiotherapy on tamoxifen; CDK4/6 inhibitor was planned but unaffordable...Goserelin was initiated; aromatase inhibitor plus CDK4/6 inhibitor remained pending...This case illustrates that ER+/HER2− breast cancer, despite its usual indolence, can rarely present with explosive relapse and life-threatening complications such as spontaneous TLS and severe thrombocytopenia. Early recognition of aggressive biology and urgent initiation of systemic therapy are critical to improve outcomes."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

NRG-GU002: Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (clinicaltrials.gov) - P2/3 | N=612 | Completed | Sponsor: NRG Oncology | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Oct 2025 | Trial primary completion date: May 2026 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=112 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2025 ➔ Sep 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Phase 2 Trial of (Z)-endoxifen + Goserelin as Neoadjuvant Treatment for Premenopausal Women with ER+, HER2-, Breast Cancer (EVANGELINE) (SABCS 2025) - P2 | "Problematically, only 41% of patients reach this threshold with tamoxifen compared to 78% with AI+OFS (Nitz JCO 2022)...Eligible patients are premenopausal women with Stage IIA/IIB ER+/HER2- breast cancer.• Part 1 (PK Run-in): assessed 40mg vs 80mg ENDX (+/- OFS) in 22 patients.• Part 2: patients with baseline Ki-67 >10% were randomized to 40 mg ENDX + goserelin or exemestane + goserelin for 6 months with the primary objective being 4-week ESD rate...EVANGELINE is the first trial to evaluate (Z)-endoxifen + OFS as neoadjuvant therapy in premenopausal ER+/HER2- breast cancer. By targeting both ER and PKC pathways, ENDX may offer a well-tolerated alternative to AI-based regimens and expand endocrine therapy options for this population. Clinical Trial Registration: NCT05607004"

Clinical • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PRKCB

A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-positive, HER2-negative Breast Cancer with a Combination Regimen of Ribociclib and Optimized Endocrine Therapy - SELECT Trial (SABCS 2025) - P2 | "Optimized ET includes an oral aromatase inhibitor (letrozole or anastrozole) for all participants, with the addition of a GnRH agonist (goserelin) to achieve gonadal suppression in all men and premenopausal women. Recruitment is ongoing. Clinical trial information: NCT06953882."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

NRG-BR009: A phase III trial evaluating addition of adjuvant chemotherapy to Ovarian Function Suppression + Endocrine Therapy in premenopausal women with pN0-1, HR+/HER2- breast cancer and recurrence score ≤25 (OFSET) (SABCS 2025) - P3 | "ET is an aromatase inhibitor (AI) per physician discretion; or tamoxifen if AI is not tolerated or if OFS is incomplete. Among 148 pts with OFS data available, 79 (53.4%) were prescribed goserelin and 69 (46.6%) leuprolide. A monthly dosing schedule was prescribed for 86.1% of pts receiving goserelin and 73.5% of those receiving leuprolide; the remaining received a 3-monthly schedule.NCT05879926 Support: U10 CA180868, -80822, UG1 CA189867, U24 CA196067"

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

When Therapy Leaves a Mark: A Case of Ribociclib-Induced Vitiligo Reversed with Abemaciclib (SABCS 2025) - "She underwent adjuvant therapy with Lupron and tamoxifen but self-discontinued treatment after three years...Treatment was initiated with ribociclib, letrozole, and zoladex; genomic profiling (NGS) showed no targetable mutations.After two years of therapy, the patient developed depigmented patches localized predominantly on the dorsal aspect of her hands, anterior neck, and face, along with ill-defined hypopigmented to near-depigmented patches on her forearms and upper arms, involving approximately 20% of her body surface area... This case contributes to the limited literature on CDK4/6 inhibitor-induced pigmentary changes. It underscores the need for clinical awareness of this rare toxicity and demonstrates that switching agents within the same drug class may offer symptom resolution without compromising cancer treatment."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • HER-2 • PGR

Factors Associated With Real-World Use of Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early-Stage HR+/HER2- Breast Cancer (SABCS 2025) - "When a GnRH agonist was used for OFS, goserelin was used in the majority. Although not statistically significant, a higher number ofrecurrences were noted in the tamoxifen alone group. Additional research is warranted to optimize the selection of patients who might benefit most from maximal hormonal blockade with OFS compared to Tam alone."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC) (SABCS 2025) - " In NATALEE, patients were randomized 1:1 to receive either RIB (400 mg/d, 3 wk on/1 wk off for 3 y) + NSAI (anastrozole 1 mg/d or letrozole 2.5 mg/d for ≥5 y) or NSAI alone; men and premenopausal women also received goserelin. In this prespecified 5-y analysis, with all patients off RIB treatment for a median of 2 y, the DDFS benefit with RIB + NSAI was sustained or improved compared with prior NATALEE analysis. This benefit was observed across all key subgroups, including N0 disease. These findings support the use of adjuvant RIB + NSAI to reduce distant recurrence risk in the NATALEE-eligible high-risk HR+/HER2− EBC population."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Dalpiciclib Combined with Letrozole as Neoadjuvant Therapy for Stage II-III HR-Positive, HER2-Negative Breast Cancer: A Phase II Study (SABCS 2025) - P2 | "This study aims to explore the efficacy and safety of dalpiciclib plus letrozole in patients with stage II-III HR+/HER2- BC. In this single-arm, open-label study (NCT05512416), early or locally advanced HR+/HER2- BC patients received six 28-day cycles of dalpiciclib (150 mg orally, once daily on days 1-21) plus letrozole (2.5 mg orally, once daily), with or without goserelin (3.6 mg, intramuscularly). Our results showed that dalpiciclib plus letrozole demonstrates a promising safety profile and antitumor activity in HR+/HER2− early/locally advanced BC, with significant suppression of proliferation (Ki‑67). These results support its potential as a fully oral, chemotherapy-free neoadjuvant regimen. Further studies are warranted to confirm these preliminary results."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

An Exploratory Clinical Trial of CDK4/6 Inhibitor Dalpiciclib Combined with Aromatase Inhibitors as Neoadjuvant Therapy for Stage II-III HR-positive HER2-negative Breast Cancer (SABCS 2025) - "Participants receive dalpiciclib 150 mg/d (d1-21 every 28 days) + AIs (letrozole 2.5 mg/d, anastrozole 1 mg/d, or exemestane 25 mg/d); premenopausal women add ovarian suppression (goserelin/leuprolide). Conclusion Dalpiciclib combined with AIs demonstrates promising efficacy and manageable toxicity as neoadjuvant therapy for stage II-III HR+/HER2- breast cancer, offering a new chemotherapy-free option. Future research should focus on biomarker-guided patient selection, long-term outcomes assessment, and comparative trials with other neoadjuvant therapies, aiming to improve the treatment paradigm for HR+/HER2- breast cancer."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Synchronous Bilateral Breast Cancer with Heterogeneous Histology: Invasive Ductal and Lobular Carcinoma - A Case Report. (PubMed, Case Rep Oncol) - "She underwent neoadjuvant chemotherapy (doxorubicin/cyclophosphamide followed by paclitaxel), followed by a left radical mastectomy with axillary dissection. Hormonal therapy (goserelin and exemestane) and adjuvant radiotherapy were initiated...Hormone receptor status, tumor biology, and extent of disease all influence treatment decisions. This rare clinical scenario highlights the need for further research and specific management guidelines."

Heterogeneity • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival. (PubMed, ESMO Open) - "This prespecified 5-year follow-up of efficacy outcomes from NATALEE demonstrated that ribociclib + NSAI continued to reduce the risk of recurrence beyond the 3-year treatment window, supporting its use as adjuvant therapy in patients with HR-positive/HER2-negative EBC. An ongoing positive trend for improved OS in favor of ribociclib + NSAI was observed."

Clinical • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

The Involvement of the Peptidergic Systems in Breast Cancer Development. (PubMed, Cancers (Basel)) - "Breast cancer cells overexpress peptide receptors; at the same time they are known to interact with peptides that (a) exert an oncogenic action (adrenomedullin 2, endothelin, gastrin-releasing peptide, neurokinin A, neuromedin, neuropeptide Y, neurotensin, substance P, vasoactive intestinal peptide), (b) exert an anticancer action (angiotensin (1-7), ghrelin, peptide YY) or (c) exert dual oncogenic and anticancer effects (adrenomedullin, angiotensin II, bradykinin, corticotropin-releasing factor, β-endorphin, glucagon-like peptide 1, gonadotropin-releasing hormone, kisspeptin, methionine-enkephalin, oxytocin)...Future lines of research are suggested in breast cancer using promising anti-breast-cancer peptide receptor antagonists (HOE-140, exendin (9-39), bosentan, macitentan, PD168,368, CGP71,683A, SR48,692, aprepitant) or agonists (FR190,997, semaglutide, exendin 4, goserelin) mentioned in this review...Taken together, the available data highlight the enormous promise..."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • GRP-10

A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | N=36 ➔ 66

Enrollment change • Endocrine Disorders

Racial Differences in Adverse Events After Androgen Deprivation in Veterans With Prostate Cancer. (PubMed, JAMA Netw Open) - "Luteinizing hormone-releasing hormone agonists (leuprolide, goserelin, or triptorelin) use as a time-dependent variable and first-line systemic therapy. Although excess risks differed slightly between Black and White patients, overall differences were small. These findings highlight the need for monitoring and mitigation strategies for patients receiving ADT."

Adverse events • Journal • Retrospective data • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Genito-urinary Cancer • Heart Failure • Musculoskeletal Diseases • Myocardial Infarction • Oncology • Peripheral Arterial Disease • Prostate Cancer • Rheumatology • Solid Tumor

Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: University of Michigan Rogel Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

Cost-Utility Analysis of Linzagolix 200 mg Plus Add-back Therapy (Linzagolix+ABT) for Symptomatic Treatment of Endometriosis (ISPOR-EU 2025) - "Linzagolix was compared against a composite of injectable GnRH agonists (leuprorelin acetate, goserelin, triptorelin). Linzagolix+ABT is cost-effective, enhances HRQoL, and reduces the need for radical surgeries, thereby also helping to preserve fertility. These benefits strongly support the adoption of linzagolix into clinical practice for endometriosis management."

HEOR • Endometriosis • Gynecology • Musculoskeletal Pain • Osteoporosis • Rheumatology • Women's Health

Adherence to Androgen Deprivation Therapy: Cancer Pharmacists Role in Optimising Care Standards in Regional Hospitals (COSA 2025) - "Across 86 episodes of care, leuprorelin was the most frequently administered (n=45), followed by degarelix (n=25) and goserelin (n=16). This project may also serve as a model for other therapies and disease states, ensuring patients receive regular follow-up regardless of where treatment is supplied. The implementation of an oncology management system in regional hospitals may further enhance future practice in this area."

Adherence • Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Rapidly dissolving microneedle patch embedded with long-acting microspheres for sustained release of goserelin. (PubMed, J Control Release) - "The GSR-MN patch demonstrates excellent biocompatibility and biosafety, and is capable of sustaining goserelin release over a 28-day period. The therapeutic outcomes were comparable to those of conventional intramuscular goserelin microsphere administration, offering a promising strategy to improve patient adherence and reduce treatment-associated discomfort."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A real-world observational study on the trends of PSA and testosterone changes in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after treatment with goserelin microspheres combined with novel hormonal agents (NHA). (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Beijing Cancer Hospital; Beijing Cancer Hospital

New P2 trial • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Solid Tumor

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: OHSU Knight Cancer Institute | N=32 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • IO biomarker • Trial withdrawal • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PD-L1

ABI1 as liquid biopsy biomarker of ARPI resistance (PCF 2025) - " ABI1 Exon 4 was consistently enriched in tumors treated with enzalutamide, a finding recapitulated in vitro following enzalutamide and apalutamide exposure. Among 125 PDXs/PDOs derived from patients receiving neoadjuvant therapy (goserelin plus enzalutamide), ABI1 Exon 4 expression was significantly elevated in AR-independent phenotypes, including treatment-induced NEPC, double-negative PCa, and AMPC... ABI1 Exon 4 functions as a critical driver of transcriptional reprogramming and AR-independent resistance in prostate cancer. Its detection in saliva and blood establishes the foundation for a liquid biopsy assay with the potential to revolutionize monitoring of treatment resistance and guide precision therapy. Conflicts of Interest Disclosure Statement."

Biomarker • Biopsy • Liquid biopsy • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor • FUS • KLK3 • NEAT1 • SRRM4

Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes (ESMO 2025) - "Methods Pts with HR+/HER2− EBC were randomized 1:1 to RIB (400 mg/d; 3 weeks on/1 week off for 3 y) + NSAI (letrozole 2.5 mg/d or anastrozole 1 mg/d for 5 y) or NSAI alone. Men and premenopausal women received goserelin...Conclusions In this 5-year landmark analysis with mature efficacy data, RIB + NSAI reduced the risk of invasive and distant disease recurrence compared with NSAI alone, including in pts with high-risk N0 disease. A positive trend for OS in favor of RIB + NSAI continues to emerge."

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2