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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Terminated

CT.gov ID

NCT00752986

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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..

Condition or Disease	Intervention/Treatment	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

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

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 Names:

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 Names:

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

Outcome Measures

Primary Outcome Measures

Event Free Survival [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

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) [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 [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 [Continuous assessment of safety.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Avellino	Italy
2	Research Site	Benevento	Italy
3	Research Site	Genova	Italy
4	Research Site	Milano	Italy
5	Research Site	Monserrato	Italy
6	Research Site	Napoli	Italy
7	Research Site	Palermo	Italy
8	Research Site	Prato	Italy
9	Research Site	Roma	Italy
10	Research Site	Trento	Italy
11	Research Site	Varese	Italy

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

D4200L00009_Clinical_Report_Synopsis

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.

Responsible Party:

Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT00752986

Other Study ID Numbers:

D4200L00009
EUDRACT 2008-000579-12

First Posted:

Sep 16, 2008

Last Update Posted:

Dec 5, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Genzyme, a Sanofi Company

Hormone Receptor Positive

Post-Menopausal Patients

post-menopausal women with hormone receptor positive advanced breast cancer

Additional relevant MeSH terms:

Breast Neoplasms

Fulvestrant

Study Results

Participant Flow

Recruitment Details	The study was prematurely terminated.
Pre-assignment Detail	39 participants were randomized to receive vandetanib or placebo.

Arm/Group Title	Vandetanib at the Dose of 100 mg	Vandetanib at the Dose of 300 mg	Placebo to Match Vandetanib 100 mg and 300 mg
Arm/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)	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 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).
Period Title: Overall Study
STARTED	16	12	11
COMPLETED	11	11	9
NOT COMPLETED	5	1	2

Baseline Characteristics

Arm/Group Title	Vandetanib at the Dose of 100 mg	Vandetanib at the Dose of 300 mg	Placebo to Match Vandetanib 100 mg and 300 mg	Total
Arm/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)	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 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).	Total of all reporting groups
Overall Participants	16	12	11	39
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.6	59.8	59.6	61.3
Sex: Female, Male (Count of Participants)
Female	16 100%	12 100%	11 100%	39 100%
Male	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Event Free Survival
Description	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.

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Vandetanib at the Dose of 100 mg	Vandetanib at the Dose of 300 mg	Placebo to Match Vandetanib 100 mg and 300 mg
Arm/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)	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 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).
Measure Participants	0	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Vandetanib at the Dose of 100 mg	Vandetanib at the Dose of 300 mg	Placebo to Match Vandetanib 100 mg and 300 mg
Arm/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)	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 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).
Measure Participants	0	0	0

3. Secondary Outcome

Title	Overall Survival
Description
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.

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Vandetanib at the Dose of 100 mg	Vandetanib at the Dose of 300 mg	Placebo to Match Vandetanib 100 mg and 300 mg
Arm/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)	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 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).
Measure Participants	0	0	0

4. Secondary Outcome

Title	Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes
Description
Time Frame	Continuous assessment of safety.

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Vandetanib at the Dose of 100 mg	Vandetanib at the Dose of 300 mg	Placebo to Match Vandetanib 100 mg and 300 mg
Arm/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)	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 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).
Measure Participants	0	0	0

Adverse Events

	Vandetanib at the Dose of 100 mg		Vandetanib at the Dose of 300 mg		Placebo to Match Vandetanib 100 mg and 300 mg
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Vandetanib at the Dose of 100 mg		Vandetanib at the Dose of 300 mg		Placebo to Match Vandetanib 100 mg and 300 mg
Arm/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)		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 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).
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Vandetanib at the Dose of 100 mg		Vandetanib at the Dose of 300 mg		Placebo to Match Vandetanib 100 mg and 300 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/16 (18.8%)		2/12 (16.7%)		1/11 (9.1%)
Blood and lymphatic system disorders
Anaemia	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
Endocrine disorders
diabetes complication	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
Gastrointestinal disorders
gastroenteritis.	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
grade 3 diarrhoea	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Injury, poisoning and procedural complications
severe arthralgia	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Musculoskeletal and connective tissue disorders
right iliac fracture	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
Skin and subcutaneous tissue disorders
grade 3 erythema	2/16 (12.5%)	2	0/12 (0%)	0	0/11 (0%)	0
Other (Not Including Serious) Adverse Events
	Vandetanib at the Dose of 100 mg		Vandetanib at the Dose of 300 mg		Placebo to Match Vandetanib 100 mg and 300 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/16 (75%)		11/12 (91.7%)		6/11 (54.5%)
Blood and lymphatic system disorders
AST ELEVATION	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
ANAEMIA	1/16 (6.3%)	3	0/12 (0%)	0	1/11 (9.1%)	1
NEUTROPENIA	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
LEUKOPENIA	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
HYPERCALCEMIA	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
HYPERTRANSAMINASEMIA	0/16 (0%)	0	2/12 (16.7%)	5	1/11 (9.1%)	1
PIASTRINOPENIA	0/16 (0%)	0	1/12 (8.3%)	3	0/11 (0%)	0
TRANSAMINASE INCREASE	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
HYPERPOTASSEMIA	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Cardiac disorders
HYPERTENSION	3/16 (18.8%)	3	2/12 (16.7%)	4	0/11 (0%)	0
TACHICARDY	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
FLUSHING	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Ear and labyrinth disorders
DIZZINESS	1/16 (6.3%)	1	1/12 (8.3%)	1	0/11 (0%)	0
VERTIGO	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Eye disorders
LEFT EYE PAIN	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
EYE ANGIOEDEMA	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Gastrointestinal disorders
RIGHT HYPOCHONDRIUM PAIN	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
DIARRHEA	3/16 (18.8%)	3	7/12 (58.3%)	14	0/11 (0%)	0
General disorders
RECTAL BLEEDING	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
HEMORRHOIDS	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
TOOTH ACHE	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
NAUSEA	2/16 (12.5%)	2	3/12 (25%)	3	0/11 (0%)	0
VOMITING	1/16 (6.3%)	1	1/12 (8.3%)	2	0/11 (0%)	0
INSOMNIA	0/16 (0%)	0	3/12 (25%)	3	0/11 (0%)	0
HEADACHE	1/16 (6.3%)	1	2/12 (16.7%)	2	0/11 (0%)	0
ANOREXIA	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
ASTHENIA	2/16 (12.5%)	2	2/12 (16.7%)	2	0/11 (0%)	0
FEVER	2/16 (12.5%)	2	2/12 (16.7%)	2	0/11 (0%)	0
ONYCHOPATY	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
WEIGHT LOSS	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
LOSS OF APPETITE	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
SWEATING	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
ARTHRALGIA	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
FATIGUE	1/16 (6.3%)	2	0/12 (0%)	0	0/11 (0%)	0
Hepatobiliary disorders
HEPATIC TOXICITY	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
Infections and infestations
MUCOSITIS	0/16 (0%)	0	1/12 (8.3%)	2	0/11 (0%)	0
STOMATITIS	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
UMBILICAL MYCOSES	1/16 (6.3%)	2	0/12 (0%)	0	0/11 (0%)	0
Musculoskeletal and connective tissue disorders
BONE PAIN	0/16 (0%)	0	3/12 (25%)	4	1/11 (9.1%)	1
JOINT PAIN	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
RIB FRACTURE	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
LUMBAR PAIN	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
MUSCOLOSKELETRICAL PAIN	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Nervous system disorders
NEUROPATHY (ARMS)	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
Psychiatric disorders
ANXIETY	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
ANXIOUS-DEPRESSIVE SYNDROME	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
Renal and urinary disorders
PROTEINURIA	0/16 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	1
CYSTITIS	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
HAEMORRHAGIC CYSTITIS	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Respiratory, thoracic and mediastinal disorders
THORACIC PAIN	0/16 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
PAIN RIGHT THORAX	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
BRONCHITIS	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0
Skin and subcutaneous tissue disorders
RASH	3/16 (18.8%)	6	6/12 (50%)	11	0/11 (0%)	0
HYPERPIGMENTATION	1/16 (6.3%)	1	1/12 (8.3%)	1	0/11 (0%)	0
ERYTHEMA	1/16 (6.3%)	1	2/12 (16.7%)	5	0/11 (0%)	0
SCALP ERITHEMA	1/16 (6.3%)	1	0/12 (0%)	0	0/11 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Results Point of Contact

Name/Title	Trial Transparency Team
Organization	Sanofi
Phone
Email	Contact-US@sanofi.com

Responsible Party:

Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT00752986

Other Study ID Numbers:

D4200L00009
EUDRACT 2008-000579-12

First Posted:

Sep 16, 2008

Last Update Posted:

Dec 5, 2016

Last Verified:

Oct 1, 2016

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

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact