To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.

NCT03658213 | Withdrawn Phase 3

• 1 other identifier: D8666C00004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

Brief 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 24.

Conditions

Breast Cancer

Keywords

Early breast cancer; Goserelin acetate; Estrogen suppression; Pre-menopausal; Zoladex

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  From screening to 4 weeks after the completion of 24 weeks treatment period.

• Change in Alanine aminotransferase(U/L)

  At scheduled visits from screening to 24th week.

• Change in Aspartate aminotransaminase(U/L)

  At scheduled visits from screening to 24th week.

• Change in Albumin(g/L)

  At scheduled visits from screening to 24th week.

• Change in Alkaline phosphatase(U/L)

  At scheduled visits from screening to 24th week.

Study Arms (2)

ZOLADEX 10.8 mg depot group

EXPERIMENTAL

• ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks

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

Drug: ZOLADEX 3.6mg

Interventions

ZOLADEX 10.8 mg DRUG

10.8 mg depot for injection (equivalent to 10.8 mg goserelin)

Also known as: ZOLADEX® (goserelin acetate implant) 10.8 mg

ZOLADEX 10.8 mg depot group

ZOLADEX 3.6mg DRUG

3.6 mg depot for injection (equivalent to 3.6 mg goserelin)

Also known as: ZOLADEX® (goserelin acetate implant) 3.6 mg

ZOLADEX 3.6 mg depot group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).
• 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.

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (11)

Research Site

Beijing, 100006, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Guangzhou, 510060, China

Location

Research Site

Guangzhou, 510100, China

Location

Research Site

Hangzhou, 310009, China

Location

Research Site

Hangzhou, 310022, China

Location

Research Site

Harbin, 150081, China

Location

Research Site

Shanghai, 200032, China

Location

Research Site

Shenyang, 110016, China

Location

Research Site

Shijiazhuang, 050035, China

Location

Research Site

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Zefei JIANG

  307 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: September 5, 2018
• Study Start: March 31, 2020
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-04

Locations

CN (11)