Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX®

May 15, 2023 updated by: Luye Pharma Group Ltd.

A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Breast Cancer

This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial using non-inferior design. A total of 188 patients with breast cancer who are suitable for endocrine therapy will be enrolled into the screening period from D-28 to D-1 before administration. Eligible subjects will be randomized in a 1:1 ratio to receive LY01005 3.6 mg intramuscularly or ZOLADEX ® 3.6 mg subcutaneously once every 28 days for three doses until intolerable toxicity, disease progression requiring other anti-tumor treatments, withdrawal of consent, loss to follow-up, death or the end of the whole study, and stratified according to history of chemotherapy (yes vs. no) and age (<45 vs. ≥45 years old). And all subjects will be also treated with tamoxifen orally twice per day (10 mg/tablet, 1 tablet/time). Blood samples will be collected at the specified time points of the study to detect serum E2, LH and FSH. Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) will be conducted as required in the protocol. Additional blood samples will be collected from 12 subjects (PK subgroup) who are randomized to LY01005 group to assess the PK and PD characteristics of LY01005 in patients with breast cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Hangzhou, China
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged ≥18 and <60 at screening, in pre-menopausal status defined as: (1) Menses within 1 year before enrolment; (2) Serum E2 >30 pg/mL and FSH ≤40 mIU/mL within 4 weeks before enrollment. (If patients received hysterectomy, they should only meet the second item.)
  • Histologically confirmed ER+ primary breast cancer (ER+ defined as at least 10% of the cells examined by immunohistochemistry testing have estrogen receptors), TNM stage (according to the 8th edition of the AJCC Cancer Staging Manual): T1-T3, any N stage, M0 or Tis/T0, lymph node positive, M0.
  • Patients who have previously received breast cancer-related surgery, have no known clinical residual local regional lesions after surgery (adjuvant radiotherapy was allowed after surgery), and are suitable for treatment with the combination of the study drug and tamoxifen as judged by the investigator (patients who have received neoadjuvant/adjuvant chemotherapy were allowed);
  • Life expectancy of more than 9 months.
  • ECOG score of ≤ 2.
  • Female patients of child bearing potential who have a negative pregnancy test and their partners must agree to the use of non-hormonal contraception throughout the study period for at least 3 months after last dose.
  • Patients who voluntarily sign an IRB-approved informed consent form before any trial-related activities, are willing to abide by the restrictions of the study, and complete the prescribed examinations.

Exclusion Criteria:

  • Any evidence of distant metastatic lesions.
  • Have received any neoadjuvant /adjuvant endocrine therapy for breast cancer previously.
  • Have received a bilateral oophorectomy, ovarian radiotherapy, hypophysectomy or adrenalectomy, or who have pituitary lesions.
  • Have received major surgery within 4 weeks prior to randomization.
  • History or presence of another malignancy, other than surgically removed squamous/basal cell carcinoma of the skin or radically resected in situ cervical carcinoma, within the last 5 years.
  • Presence of infectious diseases requiring intramuscular or intravenous drug therapy at the screening visit.
  • Suffering from serious diseases within 6 months before the screening visit, including but not limited to: acute coronary syndrome, coronary revascularization, New York Heart Association (NYHA) class ≥ II cardiac insufficiency, severe unstable arrhythmia; Or the presence of fundus disease, severe osteoporosis, uncontrolled seizures, extensive bilateral lung disease diagnosed by high-resolution computed tomography, mental diseases that prevent the signing of informed consent at the screening visit.
  • 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).
  • History of deep venous thrombosis, pulmonary embolism or stroke.
  • Total bilirubin >1.5xULN, ALT or AST >2.5xULN, platelets <90 × 10^9/L, QTc interval >460ms, creatinine clearance < 30 mL/min (calculated according to Cockcroft-Gault formula) at the screening visit.
  • Patients who are seropositive for hepatitis B surface antigen (HBsAg) must meet the following 2 conditions at the same time: 1. HBV DNA level: HBeAg-positive patients, HBV DNA ≥ 20,000 IU/ml [equivalent to 10^5 copies/mL]; HBeAg-negative patients, HBV DNA ≥ 2,000 IU/ml [equivalent to 10^4 copies/mL]; 2. ALT ≥ 2 x ULN).
  • Patients who are seropositive for any one of hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) or anti-treponema pallidum antibody (TP-Ab).
  • Known to be allergic to the active ingredients or any excipients of GnRH analogues or tamoxifen.
  • Unwilling to stop taking any drug that affects sex hormonal status.
  • Have received any investigational drug, any investigational biological product or any investigational medical device, and discontinued within 1 month or 5 half-lives of the corresponding drug before the screening visit, whichever is longer.
  • Female patients who are pregnant or breast-feeding.
  • Other conditions considered unsuitable for enrollment by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY01005 3.6 mg
Intramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses.
Drug: LY01005
LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period.
Other Names:
  • Goserelin Acetate Sustained-Release Microspheres for Injection
Active Comparator: ZOLADEX® 3.6 mg
Subcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses.
Drug: ZOLADEX® 3.6 mg
ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period.
Other Names:
  • Goserelin Acetate Implant 3.6 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Non-inferiority of LY01005 compared with ZOLADEX®: the percentage of subjects with serum E2 maintaining at postmenopausal level (≤30 pg/mL) from Week 4 to Week 12 after the first dose.
Time Frame: from Week 4 to Week 12 after the first dose
from Week 4 to Week 12 after the first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events (AE).
Time Frame: up to Week 12
up to Week 12
Changes in serum E2 level after administration.
Time Frame: from baseline to Week 12
from baseline to Week 12
Changes in serum LH level after administration.
Time Frame: from baseline to Week 12
from baseline to Week 12
Changes in serum FSH level after administration.
Time Frame: from baseline to Week 12
from baseline to Week 12
PK subgroup: changes in serum E2 level after administration to assess PD characteristic of LY01005.
Time Frame: from baseline to Week 12
from baseline to Week 12
PK subgroup: changes in serum LH level after administration to assess PD characteristic of LY01005.
Time Frame: from baseline to Week 12
from baseline to Week 12
PK subgroup: changes in serum FSH level after administration to assess PD characteristic of LY01005.
Time Frame: from baseline to Week 12
from baseline to Week 12
PK subgroup: changes in serum goserelin level after administration to assess PK characteristic of LY01005.
Time Frame: from baseline to Week 12
from baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luye Pharma Group Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LY01005/CT-CHN-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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