An Open Label, Randomised, Parallel Group, Multicentre Study toCompare ZOLADEX™ 10.8 mg Given Every 12 Weeks with ZOLADEX3.6 mg Given Every 4 Weeks in Pre-menopausal Women with OestrogenReceptor Positive Advanced Breast Cancer

• Conditions: Oestrogen receptor (ER) positive advanced breast cancer (ABC) in pre-menopausal women

• Registration Number: EUCTR2005-004001-29-CZ
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

Provision of written informed consent
- For the PK analyses in this study (see Section 4.5), optional additional blood
samples will be taken from those patients who provide written informed
consent to confirm that they are willing to participate in this part of the study.
This consent will be in addition to their written informed consent to confirm
their willingness to participate in the main study. See Section 8.3.1 for further
information
2. Female =18 years and pre-menopausal
- Pre-menopausal defined as 1) last menses within 1 year of administration of
study drug, and 2) E2 =10 pg/mL and FSH =30 mIU/mL within 4 weeks of
administration of study drug. For patients who have had a hysterectomy, it is
acceptable to meet only criterion 2.
3. Histological/cytological confirmation of locally advanced or metastatic breast
cancer and are candidates to receive hormonal therapy as therapy for advanced
disease. Patients may have received prior adjuvant chemotherapy, radiotherapy or
hormonal therapy for EBC
4. Documented evidence of hormone sensitivity (ER positive) of primary or secondary
tumour tissue
5. World Health Organization (WHO) Performance status of 0, 1 or 2 (see Appendix D)
6. At least one measurable lesion (not located in a previously irradiated area) according to RECIST with the exception of patients with bone metastases only or complete remission after prior taxane- or anthracycline based first line chemotherapy for ABC (stage IV). See Section 3.3.3, exclusion criterion 4, for further details of eligibility criteria concerning prior first line chemotherapy for ABC.
Patients with bone metastases only must fulfil one of the following conditions:
- Have osteolytic lesions identifiable by bone x-ray (patients with productive bone lesions only, as identified by bone x-ray, are not eligible),
- Have bone lesions identified by MRI or computed tomography scan (patients with productive bone lesions only, as identified by MRI or computed tomography scan, are eligible).
Patients with complete remission after prior taxane- or anthracycline based first line chemotherapy for ABC must fulfil one of the following conditions:
- Have had at least one measurable lesion (not located in a previously irradiated area) according to RECIST prior to taxane- or anthracycline based first line chemotherapy for ABC,
- Have had bone metastases meeting the criteria listed above prior to taxane- or anthracycline based first line chemotherapy for ABC.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have received tamoxifen or other hormonal therapies as adjuvant
therapy for EBC in the 24 weeks before administration of study drug; prior treatment with hormonal therapies for ABC
2. Patients who have received LHRHa as adjuvant therapy for EBC in the 48 weeks
before administration of study drug (up to 2 years of adjuvant treatment with an
LHRHa is permitted)
3. Patients who have received any radiotherapy for EBC or ABC within 4 weeks before administration of study drug
4. Prior first line chemotherapy for ABC with the exception of taxane- or
anthracycline-based chemotherapy providing that a) there is no evidence of
progressive disease since the start of the chemotherapy and b) the patient has
pre-menopausal status after starting chemotherapy. Patients who have had prior
chemotherapy for ABC must have had at least one menstrual period since starting
chemotherapy. Any taxane- or anthracycline-based chemotherapy must be
completed at least 4 weeks prior to Day 1 of this study. (Prior adjuvant
chemotherapy for EBC is allowed except when it has been administered within 4 weeks before study drug administration )
5. Prior treatment with herceptin for EBC within 4 weeks before study drug administration; prior treatment with herceptin for ABC
6. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic
involvement, or any degree (proven or suspected) of brain or leptomeningeal
involvement (past or present) or symptomatic pulmonary lymhangitic spread.
Patients with discrete pulmonary parenchymal metastases are eligible, provided
their respiratory function is not compromised as a result of disease
7. Estimated survival less than 24 weeks from the start of study therapy (Day 1) based on clinical judgment
8. History (within previous 3 years before administration of study drug) of systemic
malignancy other than breast cancer with the exception of basal cell/squamous cell
carcinoma of the skin or cancer of the cervix that has been satisfactorily controlled
9. Platelets <100x109/L; total bilirubin >1.5x upper limit of reference range (ULRR);
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5xULRR if
no demonstrable liver metastases or >5xULRR in presence of liver metastases
10. Any other significantly abnormal laboratory test result at baseline that would place the patient at unusual risk or confound the results of the study as assessed by the treating investigator
11. Treatment with a non-approved or experimental drug within the preceding 12 weeks before administration of study drug
12. Patients with a relevant history of any severe concomitant disease that would place the patient at unusual risk or confound the results of the study (eg, a strong family history of osteoporosis or severe renal or hepatic impairment) as assessed by the treating investigator
13. Patients who, for whatever reason (eg, confusion, infirmity, alcoholism) are
unlikely to comply with study requirements as assessed by the treating investigator
14. Patients considered by the investigator to be at risk of transmitting any infection
through blood or other body fluids including the agents for acquired immune
deficiency syndrome or other sexually transmitted disease or hepatitis
15. History of bleeding diathesis (ie, disseminated intravascular coagulation or clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet
therapy and low dose warfarin)
16. History of any hypersensitivity to act

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified