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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Advanced Breast Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- Pre-menopausal women aged 18 years or over with
histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast
cancer

- World Health Organization (WHO) performance status of 0, 1, or 2

- Provided written informed consent

Exclusion Criteria:

- Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC)
adjuvant in the previous 24 weeks

- Received radiotherapy within the past 4 weeks

- History of systemic malignancy other than breast cancer within the previous 3 years

- Estimated survival less than 24 weeks

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Progression Free Survival (PFS) at Week 24

Outcome Description:

The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.

Outcome Time Frame:

Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).

Safety Issue:

No

Principal Investigator

Breast Cancer Established Brands Team Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Romania: National Medicines Agency

Study ID:

D8664C00008

NCT ID:

NCT00322348

Start Date:

April 2006

Completion Date:

November 2009

Related Keywords:

  • Advanced Breast Cancer
  • oncology
  • cancer
  • breast cancer
  • Breast Neoplasms

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