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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00752986
First received: September 15, 2008
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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..


Condition Intervention Phase
Breast Cancer
Drug: ZD6474 (Vandetanib at the dose of 100 mg)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
Drug: Fulvestrant
Drug: ZD6474 (Vandetanib at the dose of 300 mg)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized,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 BC Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Event Free Survival [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Incidence and type of adverse events (AEs), clinically significant laboratory or vital sign abnormalities and electrocardiographic (ECG) changes [ Time Frame: Continuous assessment of safety. ] [ Designated as safety issue: Yes ]

Enrollment: 135
Study Start Date: December 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vandetanib at the dose of 100 mg
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)
Drug: ZD6474 (Vandetanib at the dose of 100 mg)
100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Other Name: Zactima
Drug: Fulvestrant
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.
Other Name: Faslodex
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Placebo of 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Experimental: Vandetanib at the dose of 300 mg
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)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
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
Drug: Fulvestrant
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.
Other Name: Faslodex
Drug: ZD6474 (Vandetanib at the dose of 300 mg)
300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.
Other Name: Zactima
Placebo Comparator: Placebo to match vandetanib 100 mg and 300 mg
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).
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
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
Drug: Fulvestrant
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.
Other Name: Faslodex
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Placebo of 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752986

Locations
Italy
Research Site
Avellino, AV, Italy
Research Site
Benevento, BN, Italy
Research Site
Monserrato, CA, Italy
Research Site
Genova, GE, Italy
Research Site
Milano, MI, Italy
Research Site
Palermo, PA, Italy
Research Site
Trento, TN, Italy
Research Site
Varese, VA, Italy
Research Site
Napoli, Italy
Research Site
Prato, Italy
Research Site
Roma, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Francesco Perrone, MD IRCCS ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI
Principal Investigator: Andrea De Matteis, MD IRCCS ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

Publications:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00752986     History of Changes
Other Study ID Numbers: D4200L00009, EUDRACT 2008-000579-12
Study First Received: September 15, 2008
Last Updated: November 22, 2013
Health Authority: ITALY: Comitato Etico Dell´IRCCS Istituto Nazionale Per Lo Studio E LA Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli

Keywords provided by AstraZeneca:
ZD6474
Vandetanib
Zactima
Fulvestrant
Faslodex
Breast Cancer
Advanced, Metastatic
Hormone Receptor Positive
Post-Menopausal Patients
post-menopausal women with hormone receptor positive advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones

ClinicalTrials.gov processed this record on August 28, 2014