Breast CancerPhase 3NCT03936933
Pharmacodynamic Study Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer
A Phase 3 study testing Goserelin acetate 3.6 mg Injection and ZOLADEX® 3.6mg Injection in people with Breast Cancer, run by Eurofarma Laboratorios S.A. at 1 site in India.
Trial summary
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Goserelin acetate 3.6 mg Injection and ZOLADEX® 3.6mg Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2020to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal* female patients of 18 to 59 years of age (both inclusive)
- Premenopausal female is defined by one of the following criteria: menstruating actively (< 4 months since last menstrual period [LMP]) or between 4 and 12 months after LMP with a premenopausal FSH level; patients younger than 59 years of age who became amenorrheic while on adjuvant chemotherapy will be eligible only if the FSH level is in the premenopausal range (<22.3 IU/litre). [1]
- BMI 18.5 to 30 kg/m2 (both inclusive).
- Patient with a confirmed diagnosis of early or advanced breast cancer (TNM stage I, II, III or stage IV or recurrent metastatic disease) who are scheduled to start goserelin therapy as per Investigator discretion.
- Hormone sensitivity (ER positive) of primary or secondary tumour tissue
- Patients with baseline estradiol levels >30 pg/mL
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- Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patients with life expectancy of at least 3 months as judged by the Investigator.
- Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- Patient should be able to comply with study requirement in the opinion of Investigator.
- Non-smoker defined as non-smoker for at least 6 months (i.e. subject has not smoked or used any tobacco products for the 6 months prior to the screening visit).
- Patients must not have taken any anti-androgens, estrogen, antiestrogen, aromatase inhibitors or hormonal forms of contraception within past one month of screening. Patient may have had recent use of oral contraceptive pills but these must be discontinued 30 days prior to dosing.
- Adequate hematologic status, renal and liver function.
- Women of childbearing potential (WOCBP*) must not be pregnant or breastfeeding (as documented by a negative serum pregnancy test at screening and negative urine pregnancy test at baseline).
Who cannot join
- Patients who are not able to provide written informed consent.
- Patients who are menopausal
- Patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.
- Patients who are already on GnRH receptor agonist or antagonist therapy.
- Patients who have previously failed on GnRH receptor agonist or antagonist therapy for breast cancer treatment..
- Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree (proven or suspected) of brain or leptomeningeal involvement (past or present) or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of the disease.
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- Patients who are intended to be started on any medication apart from study drug that can have impact on any of the study endpoints.
- Patients who are pregnant or breastfeeding.
- Concurrent malignancy or history of malignancy (apart from disease condition under study) within last 5 years before screening except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- Patients with a clinically significant medical condition other than breast cancer including but not limited to renal, hepatic, gastrointestinal, endocrine, cardiovascular, neurological or psychiatric disease, alcohol or substance abuse, or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator.
- Presence of clinically significant physical exam, laboratory, medical history, ECG findings that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
- Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
- Patients receiving anticoagulation medications.
- Patients with uncontrolled diabetes mellitus (HbA1c > 8 % as per ADA) at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
- Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically confirmed brain metastasis.
- Uncontrolled hypertension (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias. (Patients with hypertension controlled by antihypertensive therapies are eligible).
- Patients with a QTc>450ms on the ECG at screening.
- History of clinically significant cardiovascular disorder
- Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen which is not consistent with current medical treatment.
- Concomitant use of medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
- A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
- Patients who test positive for HIV and/or syphilis.
- The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior screening or 5 half-lives within the last dose of investigational product, whichever is longer. Current use of any drugs that are known to interfere with goserelin metabolism or to cause a drug-drug interaction.
- Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 180 days prior to receiving the first dose of study medicine.
- Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures.
- Presence of clinically significant findings on the physical exam, laboratory testing, medical history, ECG that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
- Any contraindications for goserelin administration.
- Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) starting at least four weeks before the study drug administration and up to 12 weeks after the after the last dose of study drug administration.
Trial locations and contacts
1 site in 1 country.
India1 site
Mahatma Gandhi Cancer Hospital & Research Institute
Visakhapatnam, Andhra Pradesh, 530017
About this study
Official title: Two Arm, Multicentric, Randomized, Open Label, Parallel, Multiple Dose Study Subcutaneous Injection of Goserelin 3.6 Mg (Eurofarma) Vs ZOLADEX 3.6 Mg (AstraZeneca) Administered Subcutaneously in Premenopausal Patients with Breast Cancer.
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
Read the detailed description
A phase III, two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with breast cancer
- Conditions
- Breast Cancer
- Being tested
- Goserelin acetate 3.6 mg Injection, ZOLADEX® 3.6mg Injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goserelin acetate 3.6 mg InjectionDrug
Also called Goserelin acetate
3.6 mg, Subcutaneously at every 28 days
ZOLADEX® 3.6mg InjectionDrug
Also called Zoladex
3.6 mg, Subcutaneously at every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Goserelin acetate 3.6 mg Injection | Experimental | 3.6 mg, Subcutaneously at every 28 days Receives: Drug: Goserelin acetate 3.6 mg Injection |
| ZOLADEX® 3.6mg Injection. | Active comparator | 3.6 mg, Subcutaneously at every 28 days Receives: Drug: ZOLADEX® 3.6mg Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare the pharmacodynamics
Percentage of patients with a mean estradiol concentration <30 pg/mL at day 85 days (EOS)
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start30 Oct 2020
- Primary completion30 Sep 2024
- Study completion30 Jan 2025
Why it stopped: Low recruitment rate and number of subjects is less than required after 3 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Goserelin acetate 3.6 mg Injection Eurofarma Laboratorios S.A Dose: 3.6 mg, Subcutaneously at every 28 days Reference product -R ZOLADEX® 3.6mg Injection. Dose: 3.6 mg, Subcutaneously at every 28 days
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936933
- Sponsor's protocol ID
- EF 160
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2019
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Arm, Multicentric, Randomized, Open Label, Parallel, Multiple Dose Study Subcutaneous Injection of Goserelin 3.6 Mg (Eurofarma) Vs ZOLADEX 3.6 Mg (AstraZeneca) Administered Subcutaneously in Premenopausal Patients with Breast Cancer.
- ClinicalTrials.gov ID
- NCT03936933
- Acronym / sponsor ID
- EF 160
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate and number of subjects is less than required after 3 years.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
Detailed description
A phase III, two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Goserelin acetate 3.6 mg Injection Eurofarma Laboratorios S.A Dose: 3.6 mg, Subcutaneously at every 28 days Reference product -R ZOLADEX® 3.6mg Injection. Dose: 3.6 mg, Subcutaneously at every 28 days
| Arm | Type | Receives |
|---|---|---|
| Goserelin acetate 3.6 mg Injection | Experimental | Drug: Goserelin acetate 3.6 mg Injection3.6 mg, Subcutaneously at every 28 days |
| ZOLADEX® 3.6mg Injection. | Active comparator | Drug: ZOLADEX® 3.6mg Injection3.6 mg, Subcutaneously at every 28 days |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Pre-menopausal* female patients of 18 to 59 years of age (both inclusive)
- BMI 18.5 to 30 kg/m2 (both inclusive).
- Patient with a confirmed diagnosis of early or advanced breast cancer (TNM stage I, II, III or stage IV or recurrent metastatic disease) who are scheduled to start goserelin therapy as per Investigator discretion.
- Hormone sensitivity (ER positive) of primary or secondary tumour tissue
- Patients with baseline estradiol levels >30 pg/mL
Key exclusion criteria (28 listed)
- Patients who are not able to provide written informed consent.
- Patients who are menopausal
- Patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.
- Patients who are already on GnRH receptor agonist or antagonist therapy.
- Patients who have previously failed on GnRH receptor agonist or antagonist therapy for breast cancer treatment..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goserelin acetate 3.6 mg InjectionAlso: Goserelin acetate3.6 mg, Subcutaneously at every 28 days | Drug | Goserelin acetate 3.6 mg Injection |
| ZOLADEX® 3.6mg InjectionAlso: Zoladex3.6 mg, Subcutaneously at every 28 days | Drug | ZOLADEX® 3.6mg Injection. |
Primary outcome
To evaluate and compare the pharmacodynamics
Time frame: 85 days
Percentage of patients with a mean estradiol concentration <30 pg/mL at day 85 days (EOS)
Results and safety
The study was stopped early (reason given: Low recruitment rate and number of subjects is less than required after 3 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goserelin acetate 3.6 mg Injection and ZOLADEX® 3.6mg Injection in people with Breast Cancer, run by Eurofarma Laboratorios S.A. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate and number of subjects is less than required after 3 years.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate and compare the pharmacodynamics (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.