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DRUG:

goserelin acetate

i
Other names: ZD-9393, ZD9393
Company:
Generic mfg.
Drug class:
GnRH agonist
3d
Enrollment open
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carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • goserelin acetate
15d
Tumor regression after neoadjuvant hormonal therapy in high risk prostate cancer: pathological outcomes from a randomized phase II trial. (PubMed, World J Urol)
There are subgroups of patients, such as those with low baseline cancer burden and PTEN/ERG wild-type status, more likely to achieve good response with nADT. In the case of long term oncological benefit to be proven, nADT might be an additional therapeutic resource for these patients.
Clinical • P2 data • Journal
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PTEN (Phosphatase and tensin homolog)
|
abiraterone acetate • prednisone • Erleada (apalutamide) • goserelin acetate
21d
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) (clinicaltrials.gov)
P2, N=79, Active, not recruiting, Alliance for Clinical Trials in Oncology | Trial primary completion date: Jun 2024 --> Nov 2025
Trial primary completion date • Metastases
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Xtandi (enzalutamide capsule) • goserelin acetate
25d
New P2 trial
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paclitaxel • docetaxel • capecitabine • Kisqali (ribociclib) • goserelin acetate
25d
A phase III trial of adjuvant ribociclib plus endocrine therapy vs endocrine therapy alone in patients with HR+/HER2- early breast cancer: final invasive disease-free survival results from the NATALEE trial. (PubMed, Ann Oncol)
With longer follow-up and most patients off ribociclib, NATALEE continues to demonstrate iDFS benefit with ribociclib plus NSAI over NSAI alone in the overall population and across key subgroups. Observed adverse events remained stable.
P3 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Kisqali (ribociclib) • letrozole • anastrozole • goserelin acetate
1m
YATAGARASU: A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (clinicaltrials.gov)
P2, N=31, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Sep 2025 --> Dec 2027
Trial completion date • Combination therapy • Metastases
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AR (Androgen receptor)
|
AR positive • AR expression
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Erleada (apalutamide) • goserelin acetate
1m
Trial completion • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
|
Kisqali (ribociclib) • letrozole • anastrozole • goserelin acetate
1m
BTCRC-HN17-111: Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma (clinicaltrials.gov)
P2, N=20, Recruiting, Manish Patel | Trial completion date: Sep 2024 --> Oct 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date • Metastases
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AR (Androgen receptor)
|
AR positive
|
Keytruda (pembrolizumab) • goserelin acetate
1m
Roll-over Study to Allow Continued Access to Ribociclib (clinicaltrials.gov)
P4, N=137, Recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2030 --> Feb 2028 | Trial primary completion date: Feb 2030 --> Jan 2028
Trial completion date • Trial primary completion date
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tamoxifen • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • goserelin acetate
2ms
Enrollment change
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
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Avastin (bevacizumab) • sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • SHR-A2102 • SHR-A1921 • SHR-A2009
2ms
Neoadjuvant letrozole and palbociclib in patients with HR-positive/HER2-negative early breast cancer and Oncotype DX Recurrence Score ≥18: DxCARTES study. (PubMed, ESMO Open)
The efficacy of neoadjuvant treatment with letrozole plus palbociclib does not seem to depend on pretreatment RS for patients with RS ≥18. However, around half of patients with HR-positive/HER2-negative early breast cancer with an RS 26-100 at baseline achieved molecular downstaging with this regimen.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • PTEN mutation + HR positive
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Oncotype DX Breast Recurrence Score®Test
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Ibrance (palbociclib) • letrozole • goserelin acetate
2ms
Clinical • Journal • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
HER-2 negative
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Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • goserelin acetate
2ms
A randomized phase II trial on the addition of dutasteride to combined androgen blockade therapy versus combined androgen blockade therapy alone in patients with advanced or metastatic salivary duct carcinoma - the DUCT study protocol. (PubMed, BMC Cancer)
The DUCT study addresses an unmet medical need by investigating the repurposing of dutasteride to enhance treatment response and improve clinical outcome for patients with R/M SDC, especially those with limited alternative treatment options, such as HER2-negative cases. By repurposing a registered low-cost drug, this trial's findings could be readily applied into clinical practice.
Clinical • Clinical protocol • P2 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • SRD5A1 (Steroid 5 Alpha-Reductase 1)
|
HER-2 negative • AR positive
|
bicalutamide • goserelin acetate
2ms
BOUQUET: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (clinicaltrials.gov)
P2, N=176, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Dec 2028 --> May 2028 | Trial primary completion date: May 2028 --> Feb 2028
Trial completion date • Trial primary completion date
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ER (Estrogen receptor)
|
Avastin (bevacizumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • paclitaxel • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • Verzenio (abemaciclib) • cyclophosphamide • letrozole • ipatasertib (RG7440) • triptorelin • goserelin acetate • Itovebi (inavolisib) • giredestrant (GDC-9545)
2ms
ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jul 2024 --> Mar 2025
Trial primary completion date
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ER (Estrogen receptor)
|
ER positive
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Ibrance (palbociclib) • tamoxifen • Bavencio (avelumab) • Eligard (leuprolide acetate) • goserelin acetate
2ms
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
P=N/A, N=979, Completed, Janssen Pharmaceutical K.K. | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Aug 2024
Trial completion • Trial completion date • Metastases
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docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
3ms
Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia (clinicaltrials.gov)
P=N/A, N=60, Completed, Seattle Institute for Biomedical and Clinical Research | Active, not recruiting --> Completed
Trial completion
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goserelin acetate
3ms
New P2 trial
|
goserelin acetate
3ms
Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia (clinicaltrials.gov)
P=N/A, N=60, Active, not recruiting, Seattle Institute for Biomedical and Clinical Research | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
Trial completion date • Trial primary completion date
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goserelin acetate
3ms
New P2 trial
|
Nubeqa (darolutamide) • goserelin acetate
3ms
A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. (PubMed, NPJ Breast Cancer)
Pre/perimenopausal women also received goserelin. Trial registration: ClinicalTrials.gov number, NCT03423199. Study registration date: February 06, 2018.
P3 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
|
Ibrance (palbociclib) • tamoxifen • goserelin acetate
3ms
Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
P1/2, N=9, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | N=93 --> 9
Enrollment change
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Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
3ms
Trial completion date • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
exemestane • Jingzhuda (entinostat) • goserelin acetate
3ms
Phase classification
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Ariely (adebrelimab) • SHR-A1921
4ms
NEOLETRIB: Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole (clinicaltrials.gov)
P2, N=85, Completed, University Hospital, Akershus | Recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Jul 2024
Trial completion • Trial completion date • Trial primary completion date • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
Kisqali (ribociclib) • letrozole • goserelin acetate
4ms
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
4ms
Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Trial primary completion date: Jul 2024 --> Jul 2025
Trial primary completion date
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Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
4ms
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score (clinicaltrials.gov)
P2; Trial completion date: Jan 2030 --> Jul 2031 | Trial primary completion date: Jul 2025 --> Jan 2026
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2)
|
Oncotype DX Breast Recurrence Score®Test
|
tamoxifen • fulvestrant • anastrozole • exemestane • goserelin acetate
4ms
EndomMASLD: Effect of a GnRH Analog on Hepatic Steatosis (clinicaltrials.gov)
P4, N=62, Not yet recruiting, Aristotle University Of Thessaloniki
New P4 trial
|
goserelin acetate
4ms
Long-term tamoxifen benefit in pre- and postmenopausal patients of high and low risk with luminal A and B breast cancer (ESMO 2024)
Although tamoxifen therapy is an essential treatment, the long-term benefit for patients with luminal A and B subtype is not well understood. Secondary analysis of 952 ER-positive/HER2-negative patients with luminal A or B molecular subtype from the Stockholm Tamoxifen 2, 3 and 5 trials randomized to receive tamoxifen therapy (tamoxifen alone or with goserelin) or control. Our findings suggest a long-term benefit from tamoxifen for most patients with less aggressive tumor characteristics irrespective of molecular subtype, but the benefit differed by menopausal status. Luminal B patients with PR-positive, lymph node-negative or low genomic risk tumors had a higher risk as compared to patients with luminal A tumors.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
|
Prosigna™ Breast Cancer Prognostic Gene Signature Assay
|
tamoxifen • goserelin acetate
4ms
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Dec 2031 --> Dec 2026
Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
4ms
Combination therapy • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
|
OncoPanel™ Assay
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Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
4ms
PRIMORDIUM: A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (clinicaltrials.gov)
P3, N=694, Active, not recruiting, Janssen Pharmaceutica N.V., Belgium | Recruiting --> Active, not recruiting | N=412 --> 694
Enrollment closed • Enrollment change
|
Erleada (apalutamide) • triptorelin • goserelin acetate
4ms
To explore Dalpiciclib plus AI for chemotherapy-insensitive high-risk luminal breast cancer: an single-arm, prospective study (ChiCTR2400085698)
P2, N=30, Recruiting, Breast Surgery of the First Hospital of China Medical University; The First Affiliated Hospital of China Medical University
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
AiRuiKang (dalpiciclib) • goserelin acetate
4ms
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate • leuprolide acetate for depot suspension
4ms
Enrollment change • Trial completion date • Surgery
|
docetaxel • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Viadur (leuprorelin implant)
5ms
Apalutamide and Goserelin for Androgen Receptor-Positive Salivary Gland Carcinoma: A Phase 2 Nonrandomized Clinical Trial, YATAGARASU. (PubMed, Clin Cancer Res)
Although this study did not meet the predefined efficacy criteria, apalutamide plus goserelin showed clinically meaningful efficacy in a subset of patients with AR-positive SGC and safety consistent with prior experience in prostate cancer.
Clinical • P2 data • Journal
|
AR (Androgen receptor)
|
Erleada (apalutamide) • goserelin acetate
5ms
Trial completion • Metastases
|
goserelin acetate • flutamide
5ms
A case of BRCA1 positive bilateral metachronous breast cancer in which recurrence was difficult to diagnose (JBCS 2024)
In June of X year, right breast cancer cT2N3bM0 stage â…¢C Luminal B was diagnosed and neoadjuvant chemotherapy (FEC therapy, Docetaxel therapy) was performed. In December, she underwent right mastectomy and axillary dissection, and the postoperative pathology results showed a diagnosis of ypT1aN0M0 stage I. After surgery, she was administered radiation therapy (50Gy) and tamoxifen and goserelin as postoperative adjuvant endocrine therapy...In May of X+7, the internal thoracic and mediastinal lymph nodes showed a tendency for slight enlargement, so Tamoxifen was changed to Letrozole...In September, tracheal compression and recurrent laryngeal nerve paralysis due to mediastinal lymph nodes were observed, and radiation therapy (45Gy/20Fr) was performed, after which Pembrolizumab + Carboplatin + Gemcitabine administration is ongoing...A year later, metastasis was diagnosed from a slowly growing mediastinal lymph node. We report this case, including a literature review, in which it was difficult to diagnose recurrence
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset)
|
VENTANA PD-L1 (SP142) Assay
|
Keytruda (pembrolizumab) • carboplatin • gemcitabine • docetaxel • tamoxifen • letrozole • goserelin acetate
5ms
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2030 --> Dec 2031 | Trial primary completion date: Jan 2030 --> Dec 2031
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
5ms
Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY) (clinicaltrials.gov)
P2, N=56, Active, not recruiting, National Cancer Center Hospital East | Trial completion date: Aug 2024 --> Feb 2026
Trial completion date
|
AR (Androgen receptor)
|
Nubeqa (darolutamide) • goserelin acetate
5ms
Roll-over Study to Allow Continued Access to Ribociclib (clinicaltrials.gov)
P4, N=137, Recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2029 --> Mar 2030 | Trial primary completion date: Aug 2029 --> Feb 2030
Trial completion date • Trial primary completion date
|
tamoxifen • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • goserelin acetate