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Breast CancerPhase 3NCT05110170

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

A Phase 3 study testing LY01005 and ZOLADEX® 3.6 mg in people with Breast Cancer, run by Luye Pharma Group Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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?
LY01005 and ZOLADEX® 3.6 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteChina
Study dates
15 Oct 2020to 24 Jun 2022
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

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
LY01005, ZOLADEX® 3.6 mg
Keywords
Breast Cancer, LY01005, Efficacy, Safety
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY01005Drug

    Also called Goserelin Acetate Sustained-Release Microspheres for Injection

    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.

  • ZOLADEX® 3.6 mgDrug

    Also called Goserelin Acetate Implant 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.

Study groups in NCT05110170
Study groupRoleWhat they receive
LY01005 3.6 mgExperimentalIntramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses.
Receives: Drug: LY01005
ZOLADEX® 3.6 mgActive comparatorSubcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses.
Receives: Drug: ZOLADEX® 3.6 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from Week 4 to Week 12 after the first dose

Secondary outcomes (8)

  1. Incidence of adverse events (AE).

    Measured: up to Week 12

  2. Changes in serum E2 level after administration.

    Measured: from baseline to Week 12

  3. Changes in serum LH level after administration.

    Measured: from baseline to Week 12

  4. Changes in serum FSH level after administration.

    Measured: from baseline to Week 12

  5. PK subgroup: changes in serum E2 level after administration to assess PD characteristic of LY01005.

    Measured: from baseline to Week 12

  6. PK subgroup: changes in serum LH level after administration to assess PD characteristic of LY01005.

    Measured: from baseline to Week 12

  7. PK subgroup: changes in serum FSH level after administration to assess PD characteristic of LY01005.

    Measured: from baseline to Week 12

  8. PK subgroup: changes in serum goserelin level after administration to assess PK characteristic of LY01005.

    Measured: from baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2021
  2. Study start15 Oct 2020
  3. Primary completion5 Apr 2022
  4. Study completion24 Jun 2022

Resources

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
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05110170
Sponsor's protocol ID
LY01005/CT-CHN-303
Status last verified
May 2023
First submitted
3 Nov 2021
Last updated
16 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY01005 and ZOLADEX® 3.6 mg in people with Breast Cancer, run by Luye Pharma Group Ltd. at 1 site 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 16 May 2023. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05110170.

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 16 May 2023.

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