ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial

Phase 2TerminatedNCT00752986

Genzyme, a Sanofi Company39 enrolled

Overview

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..

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Breast Cancer

Interventions

ZD6474 (Vandetanib at the dose of 100 mg)DRUG

100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

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

Placebo of 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

FulvestrantDRUG

All patients will receive fulvestrant Loading Dose (LD). The Loading Dose regimen is 500mg (2 injections) at day 1, followed by 250mg at day 14, 28 and every 28 days thereafter.

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (11)

Research Site

Avellino, Italy

Research Site

Benevento, Italy

Research Site

Genova, Italy

Research Site

Milan, Italy

Outcomes

Primary Outcomes

Event Free Survival

Success rate (patients without progression and still on treatment at 24 weeks

Time frame: Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.

Secondary Outcomes

Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)

Time frame: Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.

Overall Survival

Time frame: Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.

Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes

Time frame: Continuous assessment of safety.

Data from ClinicalTrials.gov

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