Breast CancerPhase 2ZACFASTNCT00752986

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

A Phase 2 study testing ZD6474 (Vandetanib at the dose of 100 mg), Fulvestrant and ZD6474 (Vandetanib at the dose of 300 mg) in people with Breast Cancer, run by Genzyme, a Sanofi Company at 11 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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.. Read more about this study

Who is it for?: Ages 45 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: ZD6474 (Vandetanib at the dose of 100 mg), Fulvestrant and ZD6474 (Vandetanib at the dose of 300 mg)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 11 sitesItaly
Study dates: Dec 2008to Sep 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Italy11 sites

Research Site
Avellino
Research Site
Benevento
Research Site
Genova
Research Site
Milan
Research Site
Monserrato
Research Site
Naples
Research Site
Palermo
Research Site
Prato
Research Site
Roma
Research Site
Trento
Research Site
Varese

Other trials in Italy

About this study

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

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..

Read the detailed description

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

Conditions: Breast Cancer
Being tested: ZD6474 (Vandetanib at the dose of 100 mg), Placebo to match ZD6474 (Vandetanib at the dose of 100 mg), Fulvestrant, ZD6474 (Vandetanib at the dose of 300 mg), Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Keywords: 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
Medical subject headings: Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZD6474 (Vandetanib at the dose of 100 mg)Drug
Also called Zactima
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
Also called Faslodex
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.
ZD6474 (Vandetanib at the dose of 300 mg)Drug
Also called Zactima
300 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 300 mg)Drug
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

Study groups in NCT00752986
Study group	Role	What they receive
Vandetanib at the dose of 100 mg	Experimental	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) Receives: 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	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) Receives: Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg); Drug: Fulvestrant; Drug: ZD6474 (Vandetanib at the dose of 300 mg)
Placebo to match vandetanib 100 mg and 300 mg	Placebo comparator	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). Receives: Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg); Drug: Fulvestrant; Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Event Free Survival
Success rate (patients without progression and still on treatment at 24 weeks
Measured: 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 (3)

Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)
Measured: 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
Measured: 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
Measured: Continuous assessment of safety.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Sep 2013

First posted16 Sep 2008 (estimated)
Study startDec 2008
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00752986
Sponsor's protocol ID: D4200L00009
Other IDs: EUDRACT 2008-000579-12
Acronym: ZACFAST
Status last verified: Oct 2016
First submitted: 15 Sep 2008
Last updated: 5 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ciardiello F, Caputo R, Damiano V, Caputo R, Troiani T, Vitagliano D, Carlomagno F, Veneziani BM, Fontanini G, Bianco AR, Tortora G. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res. 2003 Apr;9(4):1546-56.
PubMed 12684431

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00752986
Acronym / sponsor ID: ZACFAST / D4200L00009
Conditions: Breast Cancer
Keywords: ZD6474, Vandetanib, Zactima, Fulvestrant, Faslodex, Breast Cancer, Advanced, Metastatic, Hormone Receptor Positive
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 39 participants (actual)
Lead sponsor: Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 16 Sep 2008 (estimated)
Results: Posted 6 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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..

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Vandetanib at the dose of 100 mg	Experimental	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 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)
Vandetanib at the dose of 300 mg	Experimental	Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg), Drug: Fulvestrant, Drug: ZD6474 (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)
Placebo to match vandetanib 100 mg and 300 mg	Placebo comparator	Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg), Drug: Fulvestrant, Drug: Placebo to match ZD6474 (Vandetanib at the dose of 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).

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZD6474 (Vandetanib at the dose of 100 mg)Also: Zactima100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first	Drug	Vandetanib at the dose of 100 mg
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	Placebo to match vandetanib 100 mg and 300 mg, Vandetanib at the dose of 300 mg
FulvestrantAlso: FaslodexAll 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.	Drug	Placebo to match vandetanib 100 mg and 300 mg, Vandetanib at the dose of 100 mg, Vandetanib at the dose of 300 mg
ZD6474 (Vandetanib at the dose of 300 mg)Also: Zactima300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.	Drug	Vandetanib at the dose of 300 mg
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	Drug	Placebo to match vandetanib 100 mg and 300 mg, Vandetanib at the dose of 100 mg

Primary outcome

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

3 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.

Results and safety

Results posted to the registry on 6 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vandetanib at the Dose of 100 mg	16	11
Vandetanib at the Dose of 300 mg	12	11
Placebo to Match Vandetanib 100 mg and 300 mg	11	9

Primary outcome: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vandetanib at the Dose of 100 mg	3 of 16 (18.8%)	12 of 16 (75%)	Not reported
Vandetanib at the Dose of 300 mg	2 of 12 (16.7%)	11 of 12 (91.7%)	Not reported
Placebo to Match Vandetanib 100 mg and 300 mg	1 of 11 (9.1%)	6 of 11 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12684431Ciardiello F, Caputo R, Damiano V, Caputo R, Troiani T, Vitagliano D, Carlomagno F, Veneziani BM, Fontanini G, Bianco AR, Tortora G. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res. 2003 Apr;9(4):1546-56.
D4200L00009\_Clinical\_Report\_SynopsisLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752986, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.