Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women

NCT00322348 | Completed Phase 2 Results

• 2 other identifiers: D8664C00008Zoladex ABC Study
• Study Type: interventional
• Target: 98
• Locations: 3 countries
• Sites: 14

Brief Summary

The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks. Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of goserelin plasma concentration time profiles Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years

Conditions

Advanced Breast Cancer

Keywords

oncology; cancer; breast cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  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).

Secondary Outcomes (5)

• Objective Response Rate (ORR) at Week 24

  Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.

• Oestradiol (E2) Serum Concentrations at Week 24

  Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presented

• Maximum Plasma Concentration, Cmax (ng/mL)

  Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup

• Time to Maximum Plasma Concentration, Tmax (Hours)

  Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup

• Area Under the Plasma Concentration Curve (0-12 Weeks)

  Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup

Study Arms (2)

ZOLADEX 10.8 mg

EXPERIMENTAL

ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks

Drug: Goserelin acetate

ZOLADEX 3.6 mg

EXPERIMENTAL

ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks

Drug: Goserelin acetate

Interventions

Goserelin acetate DRUG

3.6 mg intramuscular depot injection given every 4 weeks

Also known as: Zoladex®

ZOLADEX 3.6 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Prague, Czechia

Location

Research Site

Arkhangelsk, Russia

Location

Research Site

Belgorod, Russia

Location

Research Site

Kaliningarad, Russia

Location

Research Site

Kazan, Tatarstan, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Ryazan, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Yaroslavl, Russia

Location

Research Site

Dnipropetrovsk, Ukraine

Location

Research Site

Donetsk, Ukraine

Location

Research Site

Kharkiv, Ukraine

Location

Research Site

Odesa, Ukraine

Location

Research Site

Uzhhorod, Ukraine

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; 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

Limitations and Caveats

The criteria for non-inferiority were not met for the primary efficacy endpoint (PFS at Week 24). However, since recruitment was terminated prematurely, the study was no longer adequately powered to detect non-inferiority.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Breast Cancer Established Brands Team Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2006
• First Posted: May 5, 2006
• Study Start: April 1, 2006
• Study Completion: November 1, 2009
• Last Updated: January 24, 2011
• Results First Posted: January 24, 2011

Record last verified: 2010-12

Locations

RU (8); UA (5); CZ (1)