Breast CancerPhase 3LARESNCT03658213
To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.
A Phase 3 study testing ZOLADEX 10.8 mg and ZOLADEX 3.6mg in people with Breast Cancer, run by AstraZeneca at 11 sites in China.
Trial summary
This study will recruit 168 patients in approximately 20 study centres in China. The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week… 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?
- ZOLADEX 10.8 mg and ZOLADEX 3.6mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 11 sitesChina
- Study dates
- 31 Mar 2020to 4 Nov 2021
- 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
- Provision of informed consent prior to any study specific procedures.
- Women aged ≥18 at screening, in pre-menopausal status defined as:
- Menses within 1 year before enrolment and within 3 weeks before enrolment, E2 >30 pg/mL and FSH ≤40 mIU/mL.
- Patients who received neo/adjuvant chemotherapy before randomisation should not having chemical menopause (Patients should meet: E2>30pg/mL and FSH ≤40mIU/mL) within 12 weeks after completion of the postoperative chemotherapy.
- Histologically confirmed ER+/HER2- primary invasive operable breast cancer (ER+ defined as at least 1% of the cells examined by immunohistochemistry testing have estrogen receptors).
- Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrolment are acceptable. (Please refer to Guidelines such as NCCN Clinical practice guidelines in oncology-breast cancer and CSCO-BC breast cancer guidelines for standard protocols and dosages. Please make accurate records.).
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- Have had proper surgery for primary breast cancer with no known clinical residual loco regional disease.
- World Health Organization (WHO) performance status of 0, 1, or 2.
- Female patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 3 month after last dose of Zoladex or Tamoxifen which happens later, or they must totally/truly abstain from any form of sexual intercourse.
Who cannot join
- Any evidence of metastatic disease.
- Have received other previous neo/adjuvant endocrine therapy for breast cancer.
- Other malignancy within the last 3 years except adequately treated basal cell/squamous cell carcinoma of the skin or cancer of the cervix.
- Have any unstable complication or uncontrolled infection during screening.
- Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive bilateral lung disease on High Resolution Computed Tomography scan or any psychiatric disorder that prohibits obtaining informed consent.
- Postmenopausal woman, defined as a woman fulfilling any of the following criteria:
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- Having undergone a bilateral oophorectomy
- Age ≥60 years
- Age <60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and oestradiol level in the postmenopausal range (utilising ranges from the local laboratory facility)
- If taking tamoxifen or toremifene, and age < 60 years, then FSH and plasma oestradiol level in the postmenopausal ranges (utilising ranges from the local laboratory facility)
- Have had a bilateral oophorectomy or ovarian irradiation.
- HER2 overexpression or gene amplification, i.e., immunohistochemistry (IHC)3+ or fluorescence in situ hybridisation (FISH)+, where appropriate
- Screening test results of:
- Platelets <100 × 109/L
- Total bilirubin >1.5 × upper limit reference range (ULRR)
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >2.5 × ULRR
- Any other significantly abnormal laboratory test result at screening that would place the patient at unusual risk or confound the results of the study.
- Patients with a relevant history of any severe concomitant disease that would place the patient at unusual risk or confound the results of the study, e.g., a strong family history of osteoporosis or severe renal or hepatic impairment.
- Patients who, for whatever reason (e.g., confusion, infirmity, alcoholism) are unlikely to comply with study requirements as judged by the Investigator(s).
- Patients considered by the Investigator(s) to be at risk of transmitting any infection through blood or other body fluids including the agents for acquired-immune deficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis.
- History of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC] or clotting factor deficiency) or long-term anti-coagulant therapy (other than anti platelet therapy and low dose warfarin).
- History of any hypersensitivity to active or inactive excipients of LHRH agonist or tamoxifen.
- Patients unwilling to stop taking any drug that affects sex hormonal status, or in whom it would be inappropriate to stop.
- Participation in another clinical study with an investigational product during the last 30 days.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study centre).
- Previous enrolment or randomisation of treatment in the present study.
- Female patients who are pregnant or breast-feeding.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Research Site
Beijing, 100006
Research Site
Chengdu, 610041
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510100
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Shanghai, 200032
Research Site
Shenyang, 110016
Research Site
Shijiazhuang, 050035
Research Site
Tianjin, 300060
About this study
Official title: An Open Label, Randomised, Parallel Group, Multicentre, Non-inferiority Study to Compare ZOLADEX 10.8 mg With ZOLADEX 3.6 mg in Chinese Pre-menopausal Patients With Estrogen Receptor-Positive and HER2 Negative Early Breast Cancer
This study will recruit 168 patients in approximately 20 study centres in China.
The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.
Read the detailed description
This study will recruit 168 patients in approximately 20 study centres in China.
This open label, randomised, parallel group, multicentre study in Chinese pre menopausal patients with ER+/HER2- early breast cancer will be conducted to determine whether 3 monthly ZOLADEX 10.8 mg injection is non-inferior to monthly ZOLADEX 3.6 mg injection in terms of estradiol (E2) suppression. The study will also assess the PK, pharmacodynamics (PD), safety and tolerability of two difference strengths of ZOLADEX.
Eligible patients, as judged by the Investigator after completion of the screening tests, will be registered for this study and at the same time randomised in a 1:1 ratio to receive one of the following treatments. The study treatment must start within 7 days after randomisation.
- ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks
- ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks
The primary objective:
- To examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.
The secondary objectives:
- To evaluate the safety and tolerability profiles of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot.
- To evaluate the estradiol (E2) suppression by assessment of area under the curve (AUC) of E2 serum concentration during the 24 weeks of treatment.
- To evaluate the goserelin pharmacokinetics (PK) in Chinese patients after injection of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot.
- To assess the influence on menstruous condition after injection of ZOLADEX 10.8 mg depot or ZOLADEX 3.6 mg depot.
- To assess the hormonal conditions after injection of ZOLADEX 10.8 mg depot compared with ZOLADEX 3.6 mg depot.
- Conditions
- Breast Cancer
- Being tested
- ZOLADEX 10.8 mg, ZOLADEX 3.6mg
- Keywords
- Early breast cancer, Goserelin acetate, Estrogen suppression, Pre-menopausal, Zoladex
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLADEX 10.8 mgDrug
Also called ZOLADEX® (goserelin acetate implant) 10.8 mg
10.8 mg depot for injection (equivalent to 10.8 mg goserelin)
ZOLADEX 3.6mgDrug
Also called ZOLADEX® (goserelin acetate implant) 3.6 mg
3.6 mg depot for injection (equivalent to 3.6 mg goserelin)
| Study group | Role | What they receive |
|---|---|---|
| ZOLADEX 10.8 mg depot group | Experimental | • ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks Receives: Drug: ZOLADEX 10.8 mg |
| ZOLADEX 3.6 mg depot group | Active comparator | • ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks Receives: Drug: ZOLADEX 3.6mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective inhibition rate of serum estradiol(E2)
Percentage of participants with suppressive effect of mean serum estradiol (E2) (from 4th week to 24th week) to menopausal level (≤30 pg/mL).
Measured: At scheduled visits from Week 4 through Week 24.
Secondary outcomes (36)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
All AE data will be listed and the treatment-emergence status will be flagged in the listing.
Measured: From screening to 4 weeks after the completion of 24 weeks treatment period.
Change in Alanine aminotransferase(U/L)
Data for Alanine aminotransferase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Aspartate aminotransaminase(U/L)
Data for Aspartate aminotransaminase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Albumin(g/L)
Data for Albumin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Alkaline phosphatase(U/L)
Data for Alkaline phosphatase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Calcium(mmol/L)
Data for Calcium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Creatinine(μmoI/L)
Data for Creatinine recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in High density lipoprotein cholesterol(mmol/L)
Data for High density lipoprotein cholesterol recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Inorganic phosphate(mmol/L)
Data for Inorganic phosphate recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Low density lipoprotein cholesterol(mmol/L)
Data for Low density lipoprotein cholesterol recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Plasma glucose(mmol/L)
Data for Plasma glucose recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Potassium(mmol/L)
Data for Potassium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Lactate dehydrogenase(U/L)
Data for Lactate dehydrogenase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Triglyceride(mmol/L)
Data for Triglyceride recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Sodium(mmol/L)
Data for Sodium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Total bilirubin(μmol/L)
Data for Total bilirubin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Total cholesterol(mmol/L)
Data for Total cholesterol recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Absolute neutrophil count(/L)
Data for Absolute neutrophil count recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Haematocrit(vol%)
Data for Haematocrit recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Haemoglobin(g/L)
Data for Haemoglobin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Mean cell volume(fl)
Data for Mean cell volume recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Platelet count(/L)
Data for Platelet count recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in White blood cell count (total)(/L)
Data for White blood cell count (total) recorded in the eCRF will be listed and summarized by treatment group and visit.
Measured: At scheduled visits from screening to 24th week.
Change in Systolic Blood Pressure(mmHg)
Actual data and changes from baseline in Systolic blood pressure will be summarized by visit using descriptive statistics.
Measured: At scheduled visits from screening to 24th week.
Change in Diastolic blood pressure(mmHg)
Actual data and changes from baseline in Diastolic blood pressure will be summarized by visit using descriptive statistics.
Measured: At scheduled visits from screening to 24th week.
Change in Heart rate(bpm)
Actual data and changes from baseline in Heart rate will be summarized by visit using descriptive statistics.
Measured: At scheduled visits from screening to 24th week.
To evaluate the estradiol (E2) suppression by assessment of area under the curve (AUC) of E2 serum concentration.
Area under the curve (AUC) of E2 serum concentration during 24 weeks of treatment
Measured: At scheduled visits from screening to 24th week.
Observed maximum Goserelin plasma concentration (Cmax)
Only for PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.
Measured: At scheduled visits from treatment start to treatment completion (week 24th).
Time to maximum Goserelin plasma concentration (tmax)
Only for PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.
Measured: At scheduled visits from treatment start to treatment completion (week 24th).
Area under the Goserelin plasma concentration-time curve from time zero to time of the last measurable concentration (AUCt)
Only for PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.
Measured: At scheduled visits from treatment start to treatment completion (week 24th).
Area under the Goserelin plasma concentration-time curve from time zero to 4 weeks (AUC (0-4 weeks))
Only for 3.6 mg PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.
Measured: At scheduled visits from treatment start to 4 Weeks.
Area under the Goserelin plasma concentration-time curve from time zero to 12 weeks (AUC (0-12 weeks))
Only for 10.8 mg PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.
Measured: At scheduled visits from treatment start to 12 Weeks.
Trough concentration (Ctrough)
Goserelin plasma concentration of pre-dose sample during multiple dose period.
Measured: At scheduled visits from treatment start to treatment completion (24th week).
The rate of participants who had menstruation.
The proportion of subjects who had menstruation at each time point will be summarized by treatment group.
Measured: At scheduled visits from screening to treatment completion (24th week), approximately 27 weeks.
E2 serum concentrations
E2 concentration at each visit will be listed and summarized for each treatment group using descriptive statistics. Mean E2 concentration versus time plots and individual FSH concentration versus time plots will be presented.
Measured: At scheduled visits from screening to treatment completion (24th week), approximately 27 weeks.
FSH serum concentrations
FSH concentration at each visit will be listed and summarized for each treatment group using descriptive statistics. Mean FSH concentration versus time plots and individual FSH concentration versus time plots will be presented.
Measured: At scheduled visits from screening to treatment completion (24th week), approximately 27 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start31 Mar 2020 (estimated)
- Primary completion4 Nov 2021 (estimated)
- Study completion4 Nov 2021 (estimated)
Why it stopped: CTP of LARES has been out of the expire date, we are trying RWS pathway for the indication expend
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zefei JIANG, Principal investigator, 307 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658213
- Sponsor's protocol ID
- D8666C00004
- Acronym
- LARES
- Status last verified
- Apr 2021
- First submitted
- 27 Jun 2018
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Parallel Group, Multicentre, Non-inferiority Study to Compare ZOLADEX 10.8 mg With ZOLADEX 3.6 mg in Chinese Pre-menopausal Patients With Estrogen Receptor-Positive and HER2 Negative Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03658213
- Acronym / sponsor ID
- LARES / D8666C00004
- Conditions
- Breast Cancer
- Keywords
- Early breast cancer, Goserelin acetate, Estrogen suppression, Pre-menopausal, Zoladex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: CTP of LARES has been out of the expire date, we are trying RWS pathway for the indication expend
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (estimated)
- Primary completion
- 4 Nov 2021 (estimated)
- Study completion
- 4 Nov 2021 (estimated)
- First posted
- 5 Sep 2018 (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.
This study will recruit 168 patients in approximately 20 study centres in China.
The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.
Detailed description
This study will recruit 168 patients in approximately 20 study centres in China.
This open label, randomised, parallel group, multicentre study in Chinese pre menopausal patients with ER+/HER2- early breast cancer will be conducted to determine whether 3 monthly ZOLADEX 10.8 mg injection is non-inferior to monthly ZOLADEX 3.6 mg injection in terms of estradiol (E2) suppression. The study will also assess the PK, pharmacodynamics (PD), safety and tolerability of two difference strengths of ZOLADEX.
Eligible patients, as judged by the Investigator after completion of the screening tests, will be registered for this study and at the same time randomised in a 1:1 ratio to receive one of the following treatments. The study treatment must start within 7 days after randomisation.
- ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks
- ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks
The primary objective:
- To examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.
The secondary objectives:
- To evaluate the safety and tolerability profiles of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot.
- To evaluate the estradiol (E2) suppression by assessment of area under the curve (AUC) of E2 serum concentration during the 24 weeks of treatment.
- To evaluate the goserelin pharmacokinetics (PK) in Chinese patients after injection of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot.
- To assess the influence on menstruous condition after injection of ZOLADEX 10.8 mg depot or ZOLADEX 3.6 mg depot.
- To assess the hormonal conditions after injection of ZOLADEX 10.8 mg depot compared with ZOLADEX 3.6 mg depot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZOLADEX 10.8 mg depot group | Experimental | Drug: ZOLADEX 10.8 mg• ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks |
| ZOLADEX 3.6 mg depot group | Active comparator | Drug: ZOLADEX 3.6mg• ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of informed consent prior to any study specific procedures.
- Women aged ≥18 at screening, in pre-menopausal status defined as:
- Histologically confirmed ER+/HER2- primary invasive operable breast cancer (ER+ defined as at least 1% of the cells examined by immunohistochemistry testing have estrogen receptors).
- Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrolment are acceptable. (Please refer to Guidelines such as NCCN Clinical practice guidelines in oncology-breast cancer and CSCO-BC breast cancer guidelines for standard protocols and dosages. Please make accurate records.).
- Have had proper surgery for primary breast cancer with no known clinical residual loco regional disease.
Key exclusion criteria (27 listed)
- Any evidence of metastatic disease.
- Have received other previous neo/adjuvant endocrine therapy for breast cancer.
- Other malignancy within the last 3 years except adequately treated basal cell/squamous cell carcinoma of the skin or cancer of the cervix.
- Have any unstable complication or uncontrolled infection during screening.
- Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive bilateral lung disease on High Resolution Computed Tomography scan or any psychiatric disorder that prohibits obtaining informed consent.
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 |
|---|---|---|
| ZOLADEX 10.8 mgAlso: ZOLADEX® (goserelin acetate implant) 10.8 mg10.8 mg depot for injection (equivalent to 10.8 mg goserelin) | Drug | ZOLADEX 10.8 mg depot group |
| ZOLADEX 3.6mgAlso: ZOLADEX® (goserelin acetate implant) 3.6 mg3.6 mg depot for injection (equivalent to 3.6 mg goserelin) | Drug | ZOLADEX 3.6 mg depot group |
Primary outcome
Effective inhibition rate of serum estradiol(E2)
Time frame: At scheduled visits from Week 4 through Week 24.
Percentage of participants with suppressive effect of mean serum estradiol (E2) (from 4th week to 24th week) to menopausal level (≤30 pg/mL).
36 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From screening to 4 weeks after the completion of 24 weeks treatment period.
Change in Alanine aminotransferase(U/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Aspartate aminotransaminase(U/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Albumin(g/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Alkaline phosphatase(U/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Calcium(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Creatinine(μmoI/L)
Time frame: At scheduled visits from screening to 24th week.
Change in High density lipoprotein cholesterol(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Inorganic phosphate(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Low density lipoprotein cholesterol(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Plasma glucose(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Potassium(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Lactate dehydrogenase(U/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Triglyceride(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Sodium(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Total bilirubin(μmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Total cholesterol(mmol/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Absolute neutrophil count(/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Haematocrit(vol%)
Time frame: At scheduled visits from screening to 24th week.
Change in Haemoglobin(g/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Mean cell volume(fl)
Time frame: At scheduled visits from screening to 24th week.
Change in Platelet count(/L)
Time frame: At scheduled visits from screening to 24th week.
Change in White blood cell count (total)(/L)
Time frame: At scheduled visits from screening to 24th week.
Change in Systolic Blood Pressure(mmHg)
Time frame: At scheduled visits from screening to 24th week.
Change in Diastolic blood pressure(mmHg)
Time frame: At scheduled visits from screening to 24th week.
Change in Heart rate(bpm)
Time frame: At scheduled visits from screening to 24th week.
To evaluate the estradiol (E2) suppression by assessment of area under the curve (AUC) of E2 serum concentration.
Time frame: At scheduled visits from screening to 24th week.
Observed maximum Goserelin plasma concentration (Cmax)
Time frame: At scheduled visits from treatment start to treatment completion (week 24th).
Time to maximum Goserelin plasma concentration (tmax)
Time frame: At scheduled visits from treatment start to treatment completion (week 24th).
Area under the Goserelin plasma concentration-time curve from time zero to time of the last measurable concentration (AUCt)
Time frame: At scheduled visits from treatment start to treatment completion (week 24th).
Area under the Goserelin plasma concentration-time curve from time zero to 4 weeks (AUC (0-4 weeks))
Time frame: At scheduled visits from treatment start to 4 Weeks.
Area under the Goserelin plasma concentration-time curve from time zero to 12 weeks (AUC (0-12 weeks))
Time frame: At scheduled visits from treatment start to 12 Weeks.
Trough concentration (Ctrough)
Time frame: At scheduled visits from treatment start to treatment completion (24th week).
The rate of participants who had menstruation.
Time frame: At scheduled visits from screening to treatment completion (24th week), approximately 27 weeks.
E2 serum concentrations
Time frame: At scheduled visits from screening to treatment completion (24th week), approximately 27 weeks.
FSH serum concentrations
Time frame: At scheduled visits from screening to treatment completion (24th week), approximately 27 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: Undecided
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zefei JIANG principal investigator
307 Hospital of PLA
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZOLADEX 10.8 mg and ZOLADEX 3.6mg in people with Breast Cancer, run by AstraZeneca at 11 sites in China.
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 9 inclusion and 27 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: withdrawn, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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 withdrawn before enrolling participants, so there are no results.
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?
Effective inhibition rate of serum estradiol(E2) (time frame: At scheduled visits from Week 4 through Week 24.). 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 10 May 2021.