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

NCT01073865 | Completed Phase 3 Results

• 1 other identifier: D8666C00001
• Study Type: interventional
• Target: 222
• Locations: 6 countries
• Sites: 55

Brief Summary

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.

Conditions

Breast Cancer

Keywords

ZOLADEX; Pre-menopausal; Oestrogen Receptor; Advanced Breast Cancer; Progression Free Survival

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 weeks after the first dosing

Secondary Outcomes (2)

• Number of Responders at 24 Weeks

  24 weeks after the first dosing

• Oestradiol (E2) Serum Concentrations at 24 Weeks

  24 weeks after the first dosing

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

ZD9393 (Zoladex) 10.8 mg DRUG

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

Also known as: Zoladex

1

ZD9393 (Zoladex) 3.6 mg DRUG

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

Also known as: Zoladex

2

Eligibility Criteria

• Age: 20 Years - 130 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (55)

Research Site

Ahmedabad, 380009, India

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Bangalore, 560029, India

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Bangalore, 560090, India

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Chennai, 600010, India

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Hubli, 580025, India

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Hyderabad, 500024, India

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Jaipur, 302017, India

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Mumbai, 400012, India

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Nagpur, 440012, India

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New Delhi, 110060, India

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New Delhi, 110085, India

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Pune, 411001, India

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Pune, 411004, India

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Pune, 411005, India

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Thiruvananthapuram, 695011, India

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Amagasaki-shi, 660-8511, Japan

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Chiba, 260-8717, Japan

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Chūōku, 104-8560, Japan

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Fukuoka, 811-1395, Japan

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Hamamatsu, 430-0906, Japan

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Hiroshima, 730-8518, Japan

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Kagoshima, 892-0833, Japan

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Kamogawa-shi, 296-0041, Japan

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Kitaadachi, 362-0806, Japan

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Kumamoto, 862-8505, Japan

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Kyoto, 602-8566, Japan

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Mitaka-shi, 181-8611, Japan

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Nagoya, 464-8681, Japan

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Nagoya, 465-0024, Japan

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Niigata, 951-8566, Japan

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Osaka, 540-0006, Japan

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Osaka, 553-0003, Japan

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Sakaishi, 593-8304, Japan

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Sapporo, 003-0804, Japan

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Cebu City, 6000, Philippines

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Iloilo City, 5000, Philippines

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Lipa City, 4217, Philippines

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Pasay, Philippines

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Quezon City, 1104, Philippines

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Quezon City, Philippines

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Seoul, 05505, South Korea

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Seoul, 135-710, South Korea

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Seoul, 139-706, South Korea

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Suwon, 16499, South Korea

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Kaohsiung City, 807, Taiwan

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Taichung, 40705, Taiwan

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Taichung, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11217, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Maharat Nakorn Ratchasima, 30000, Thailand

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Songkhla, 90110, Thailand

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Ubonratchathani, 34000, Thailand

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Related Links

• D8666C00001ClinicalStudyProtocol\_personal\_info\_redacted\_12December.pdf

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

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

clinicaltrialtransparency@astrazeneca.com

+44 1509 645895

Study Officials

• Justin Lindemann, PO

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: February 26, 2010
• Primary Completion: September 19, 2012
• Study Completion: November 20, 2017
• Last Updated: December 12, 2018
• Results First Posted: January 10, 2014

Record last verified: 2018-11

Locations

TH (6); TW (5); KR (4); JP (19); PH (6); IN (15)