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Completed

NCT Number: NCT01073865

Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.

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Key information

Conditions

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

Age range

20 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ahmedabad, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation.
  • Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
  • Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.

Exclusion criteria

  • Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer
  • Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation
  • Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or

Treatment and study plan

ZD9393 (Zoladex) 10.8 mg

Drug

10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).

Other names: Zoladex

ZD9393 (Zoladex) 3.6 mg

Drug

3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

Other names: Zoladex

Primary outcomes

  1. Number of Patients With Progression-free Survival (PFS) at 24 Weeks

    Time frame: 24 weeks after the first dosing

    A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.

Secondary outcomes

  1. Number of Responders at 24 Weeks

    Time frame: 24 weeks after the first dosing

    Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.

  2. Oestradiol (E2) Serum Concentrations at 24 Weeks

    Time frame: 24 weeks after the first dosing

    E2 serum concentrations (pg/mL) at 24 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer.

Important dates

Study start
2010
Primary completion
2012
Study completion
2017
First posted
Feb 23, 2010
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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