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

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ClinicalTrials.gov Identifier: NCT01073865
Recruitment Status : Active, not recruiting
First Posted : February 23, 2010
Results First Posted : January 10, 2014
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Breast Cancer Drug: ZD9393 (Zoladex) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : February 26, 2010
Primary Completion Date : September 19, 2012
Estimated Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Patients With Progression-free Survival (PFS) at 24 Weeks [ Time Frame: 24 weeks after the first dosing ]
    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 :
  1. Number of Responders at 24 Weeks [ Time Frame: 24 weeks after the first dosing ]
    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.

  2. Oestradiol (E2) Serum Concentrations at 24 Weeks [ Time Frame: 24 weeks after the first dosing ]
    E2 serum concentrations (pg/mL) at 24 weeks


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 130 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073865


  Show 55 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Justin Lindemann, PO AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01073865     History of Changes
Other Study ID Numbers: D8666C00001
First Posted: February 23, 2010    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: August 25, 2017
Last Verified: August 2017

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents