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Goserelin

Phase 4

Early-stage Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Trials Updated: Jun 29, 2023

Goserelin development status

Highest phase Phase 4 (NCT00255268)
Phase scored for AZNPhase 3
Registered trials 60 across 36 sponsors since Nov 2005

Goserelin target and mechanism

Molecular targetGNRHR
Target classAgonist
ModalitySmall molecule

Also known as Goserelin acetate, Goserelin (Zoladex), Goserelin acetate (Zoladex), Zoladex, Zoladex® LA, LHRH agonist, Triptorelin, Leuprolide

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials5
Total Enrollment2,189

FDA Designations

No designations recorded

Goserelin clinical trials

Goserelin · 5 trials · 4 indications

Phase 3 3Phase 2 2
NCT00309478Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive PatientsEarly-stage Breast Cancer
COMPLETED1,099 Analytics
NCT00439751Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical RadiotherapyProstate Cancer
COMPLETED79 Analytics
NCT00423475Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate CancerProstate Cancer
COMPLETED743 Analytics
PHASE3COMPLETED
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
Early-stage Breast CancerUnlock trial analytics
PHASE3COMPLETED
Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy
Prostate CancerUnlock trial analytics
PHASE3COMPLETED
Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease-free survival
Overall survival
Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.
Every 6 months
Progression-free (biological and/or clinical) survival
3.5 years
Percentage of Participants With Progression Free Survival (PFS) at Week 24
Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).

The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.

Zoladex 10.8mg depot (every 12 weeks) is non-inferior to Zoladex 3.6mg depot (every 4 weeks) in terms of oestradiol (E2) suppression in patient population by assessment of area under the curve of E2 concentration during the first 24 weeks of treatment.
every 12 weeks

Secondary Endpoints

Toxicities
Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures.
Every 6 months
Quality of life
Every 6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2 (CMF scheme)EXPERIMENTAL6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
1 (Nol + Zol)EXPERIMENTALZoladex (3 years) combined with Nolvadex (5 years)
Immediate ADTOTHER -
Deferred ADTOTHER -
IACTIVE_COMPARATORExclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
IIEXPERIMENTALRadiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
ZOLADEX 10.8 mgEXPERIMENTALZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX 3.6 mgEXPERIMENTALZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1EXPERIMENTALZoladex 3-month depot
2EXPERIMENTALZoladex 1-month depot

Interventions

NameTypeDescription
CyclophosphamideDRUGCyclophosphamide 600mg/m2
MethotrexateDRUGMethotrexate 40mg/m2
Fluorouracil implantDRUGFluorouracil 600mg/m2
GoserelinDRUGZoladex 3.6mg/28 days for 3 years
TamoxifenDRUGNolvadex 20mg/day for 5 years
Goserelin AcetateDRUGContinuous goserelin, 12 week (10.8 mg) depot, will be used as ADT for both study arms. It is supplied as a sterile syringe for subcutaneous use.
adjuvant therapyPROCEDURE -
radiation therapyRADIATION -
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Eligibility Criteria

Age Range19 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer * Hormone receptor-positive status * More than 6 histologically examined lymph nodes * Laboratory parameters 1. hematopoiesis: \> 3500/µl leuk...

Countries:CanadaFranceCzechiaRussiaUkraineJapan
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Frequently asked questions about Goserelin

What is goserelin used for?

Goserelin is used in oncology for prostate cancer and breast cancer, including advanced breast cancer, early-stage breast cancer, and recurrent prostate cancer. It is a small molecule developed by AstraZeneca PLC under the ticker AZN. The clinical program covers hormone-sensitive disease settings in both men and premenopausal women.

What does goserelin target?

Goserelin targets GNRHR, the gonadotropin-releasing hormone receptor, and acts as an agonist at that receptor. By binding GNRHR as an agonist, goserelin suppresses the hormonal signaling that drives growth of hormone-sensitive prostate and breast tumors. This mechanism underlies its use as an androgen deprivation and hormonal therapy approach.

Who makes goserelin?

Goserelin is developed and marketed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the goserelin clinical program in prostate cancer and breast cancer, including the Zoladex branded formulation studied in advanced breast cancer.

What phase is goserelin in?

Goserelin has been studied across Phase 2 and Phase 3 clinical development in prostate cancer and breast cancer. The program includes completed Phase 3 trials in prostate cancer and early-stage breast cancer, plus a completed Phase 2 trial in advanced breast cancer. No active trials are currently listed for this asset.

What clinical trials is goserelin in?

Goserelin has been evaluated in completed trials including NCT00439751, which compared immediate versus deferred androgen deprivation with goserelin in recurrent prostate cancer after radical radiotherapy, and NCT00423475, which tested radiation therapy with or without goserelin after surgery for recurrent or refractory prostate cancer. Breast cancer studies include NCT00322348 and NCT00309478.

Is goserelin the same as Zoladex?

Yes, Zoladex is a brand name for goserelin, and the active form is goserelin acetate. Other names used for the same agent include goserelin acetate and Goserelin Acetate. Searches for Zoladex, goserelin, or goserelin acetate all refer to the same AstraZeneca product.