Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients

NCT00303524 | Completed Phase 2

• 2 other identifiers: D8664C00004Zoladex EBC Study
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 22

Brief Summary

The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Zoladex 10.8mg depot (every 12 weeks) is non-inferior to Zoladex 3.6mg depot (every 4 weeks) in terms of oestradiol (E2) suppression in patient population by assessment of area under the curve of E2 concentration during the first 24 weeks of treatment.

  every 12 weeks

Secondary Outcomes (1)

• Zoladex 10.8mg has similar safety and tolerability profile to Zoladex 3.6mg. Examination of goserelin pharmacokinetics (PK) in Japanese patients after injection of Zoladex 10.8mg. Efficacy of Zoladex 10.8mg is similar to 3.6mg by assessment of DFS.

  every 12 weeks

Study Arms (2)

1

EXPERIMENTAL

Zoladex 3-month depot

Drug: Goserelin acetate

2

EXPERIMENTAL

Zoladex 1-month depot

Drug: Goserelin acetate

Interventions

Goserelin acetate DRUG

Injection 3.6 mg monthly

Also known as: Zoladex

2

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2.

You may not qualify if:

• Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (22)

Research Site

Chiba, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Fukushima, Japan

Location

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Isehara, Japan

Location

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Kagoshima, Japan

Location

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Kashiwa, Japan

Location

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Kawasaki, Japan

Location

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Kitakyushu, Japan

Location

Research Site

Kumamoto, Japan

Location

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Matsuyama, Japan

Location

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Miyazaki, Japan

Location

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Nagoya, Japan

Location

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Niigata, Japan

Location

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Osaka, Japan

Location

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Ōta-ku, Japan

Location

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Saitama, Japan

Location

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Sayama, Japan

Location

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Shimotsuke, Japan

Location

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Suita, Japan

Location

Research Site

Tokorozawa, Japan

Location

Research Site

Tokyo, Japan

Location

Research Site

Utsunomiya, Japan

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

• AstraZeneca Japan Medical Director, MD

  AstraZeneca

  STUDY DIRECTOR

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: March 16, 2006
• First Posted: March 17, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: February 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

JP (22)