A randomised, double-blind, parallel-group, multicentre, phase ii study to evaluate the safety and pharmacological activity of the combination of Vandetanib (100 or 300 mg/daily or placebo) with Fulvestrant (loading dose), in postmenopausal advanced breast cancer patients - ZACFAST

Phase 1

• Conditions: Postmenopausal women with advanced breast cancer; MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000579-12-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-14
• Study Completion: 2013-09-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

1. Written informed consent
2. Post menopausal woman, defined as a woman fulfilling any 1 of the following
criteria
3. Histologically or cytologically confirmed carcinoma of the breast
4. Patients with metastatic or locally advanced disease not amenable to therapy with
curative intent
5. Patients may have either measurable or non-measurable disease, as defined by
RECIST criteria
6. Must have estrogen receptor ER + and/or progesterone receptor PR+ on primary or
secondary tumour
7. Either patients relapsing during adjuvant treatment or patients presenting with
locally advanced or metastatic breast cancer
8. One previous chemotherapy for advanced disease is allowed (patients who have
stable but evident disease after chemotherapy are eligible)
9. One previous hormone therapy for advanced disease is allowed
10. Neoadjuvant or adjuvant therapy for breast cancer is allowed
11. Patients must have an ECOG PS < 2 and a life expectancy of at least 12 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Hormone receptor negative tumours (ER and PgR negative)
2. Prior therapy with fulvestrant or prior treatment with VEGFR TKIs (previous
treatment with bevacizumab [Avastin] is permitted)
3. More than one previous hormone-therapy for the advanced disease as defined
before
4. More than one previous chemo-therapy for the advanced disease as defined before
5. CNS metastases
6. Presence of life-threatening metastatic visceral disease, defined as extensive
hepaticinvolvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete
pulmonary parenchymal metastases are eligible, provided their respiratory function
is not clinically and significantly compromised as a result of disease

Study & Design

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