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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01073865
First received: February 22, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 advanced or recurrent 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.


Condition Intervention Phase
Breast Cancer
Drug: ZD9393 (Zoladex)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Patients With Progression-free Survival (PFS) at 24 Weeks [ Time Frame: 24 weeks after the first dosing ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Responders at 24 Weeks [ Time Frame: 24 weeks after the first dosing ] [ Designated as safety issue: No ]
    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.

  • Oestradiol (E2) Serum Concentrations at 24 Weeks [ Time Frame: 24 weeks after the first dosing ] [ Designated as safety issue: No ]
    E2 serum concentrations (pg/mL) at 24 weeks


Enrollment: 286
Study Start Date: February 2010
Estimated Study Completion Date: July 2015
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).

One oral tamoxifen 20 mg tablet also will be taken daily

Drug: ZD9393 (Zoladex)
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
Other Name: Zoladex
Active Comparator: 2
Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
Drug: ZD9393 (Zoladex)
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Other Name: Zoladex

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. For patients who have had a hysterectomy, it is acceptable to meet only
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073865

  Show 43 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Justin Lindemann, PO AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01073865     History of Changes
Other Study ID Numbers: D8666C00001
Study First Received: February 22, 2010
Results First Received: August 19, 2013
Last Updated: July 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
India: Drugs Controller General of India
Korea: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Thailand: Food and Drug Administration
Taiwan: Institutional Review Board

Keywords provided by AstraZeneca:
ZOLADEX
Pre-menopausal
Oestrogen Receptor
Advanced Breast Cancer
Progression Free Survival

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Goserelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014