ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial (ZACFAST)

Genzyme

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg); Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg); Drug: Fulvestrant; Drug: ZD6474 (Vandetanib at the dose of 300 mg); Drug: ZD6474 (Vandetanib at the dose of 100 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752986

D4200L00009

EUDRACT 2008-000579-12

Details and patient eligibility

About

The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..

Full description

end-point Efficacy: event-free survival (EFS)

Enrollment: 39 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post menopausal women with locally advanced or metastatic breast cancer
• Patients may have either measurable or non-measurable disease, as defined by RECIST criteria
• One previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
• estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or secondary tumour

Exclusion criteria

• Hormone receptor negative tumours (ER and PR negative)
• Presence of life-threatening metastatic visceral disease
• Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
• History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 3 patient groups, including a placebo group

Vandetanib at the dose of 100 mg

Experimental group

Description:

vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

Treatment:

Drug: ZD6474 (Vandetanib at the dose of 100 mg)

Drug: Fulvestrant

Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)

Vandetanib at the dose of 300 mg

Experimental group

Description:

vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

Treatment:

Drug: ZD6474 (Vandetanib at the dose of 300 mg)

Drug: Fulvestrant

Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)

Placebo to match vandetanib 100 mg and 300 mg

Placebo Comparator group

Description:

placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).

Treatment:

Drug: Fulvestrant

Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)

Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)