Overview

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

Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Luye Pharma Group Ltd.
Treatments:
Goserelin
Criteria
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.