ZACtima FASlodex Trial in Postmenopausal Advance Breast C... | NCT00752986

NCT00752986

ID	Type	Description	Link
EUDRACT 2008-000579-12

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)	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)	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).	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
Event Free Survival	Success rate (patients without progression and still on treatment at 24 weeks	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.

Measure	Description	Time Frame
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

Eligibility Module

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Avellino			Italy
Research Site

PubMed Identifier	Type	Citation	Retractions
12684431	Background	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.

Label	URL
D4200L00009\_Clinical\_Report\_Synopsis	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)
FG001	Vandetanib at the Dose of 300 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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)
BG001	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)
BG002	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).
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG00112 BG00211 BG00339

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Event Free Survival

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

Posted

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.

ID	Title	Description
OG000	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)
OG001	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)
OG002	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).

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

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

Posted

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.

ID	Title	Description
OG000	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)
OG001	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)
OG002	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).

Secondary

Overall Survival

Posted

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

ID	Title	Description
OG000	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)
OG001	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)
OG002	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).

Units	Counts
Participants

Secondary

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

Posted

Continuous assessment of safety.

ID	Title	Description
OG000	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)
OG001	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)
OG002	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).

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)	3	16	12	16
EG001	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)	2	12	11	12
EG002	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).	1	11	6	11

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
diabetes complication	Endocrine disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
grade 3 erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
right iliac fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
severe arthralgia	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
gastroenteritis.	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
grade 3 diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
RIGHT HYPOCHONDRIUM PAIN	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
AST ELEVATION	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
RECTAL BLEEDING	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
HEMORRHOIDS	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events1 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
NEUTROPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
LEUKOPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0014 events3 affected12 at risk EG0021 events1 affected11 at risk
HYPERCALCEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
HYPERTRANSAMINASEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0015 events2 affected12 at risk EG0021 events1 affected11 at risk
TOOTH ACHE	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
PROTEINURIA	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
LEFT EYE PAIN	Eye disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected12 at risk EG0021 events1 affected11 at risk
DIARRHEA	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected16 at risk EG00114 events7 affected12 at risk EG0020 events0 affected11 at risk
MUCOSITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected12 at risk EG0020 events0 affected11 at risk
NAUSEA	General disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0013 events3 affected12 at risk EG0020 events0 affected11 at risk
VOMITING	General disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events1 affected12 at risk EG0020 events0 affected11 at risk
HEPATIC TOXICITY	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
INSOMNIA	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events3 affected12 at risk EG0020 events0 affected11 at risk
RASH	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 events3 affected16 at risk EG00111 events6 affected12 at risk EG0020 events0 affected11 at risk
HEADACHE	General disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected12 at risk EG0020 events0 affected11 at risk
ANXIETY	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
PIASTRINOPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events1 affected12 at risk EG0020 events0 affected11 at risk
ANOREXIA	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
ASTHENIA	General disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events2 affected12 at risk EG0020 events0 affected11 at risk
HYPERTENSION	Cardiac disorders	Systematic Assessment	EG0003 events3 affected16 at risk EG0014 events2 affected12 at risk EG0020 events0 affected11 at risk
FEVER	General disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events2 affected12 at risk EG0020 events0 affected11 at risk
ONYCHOPATY	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
JOINT PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
HYPERPIGMENTATION	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
RIB FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
STOMATITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
NEUROPATHY (ARMS)	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0015 events2 affected12 at risk EG0020 events0 affected11 at risk
WEIGHT LOSS	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
LOSS OF APPETITE	General disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
DIZZINESS	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
ANXIOUS-DEPRESSIVE SYNDROME	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
THORACIC PAIN	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
TACHICARDY	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected12 at risk EG0020 events0 affected11 at risk
VERTIGO	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
SWEATING	General disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
EYE ANGIOEDEMA	Eye disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
CYSTITIS	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
LUMBAR PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
TRANSAMINASE INCREASE	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
PAIN RIGHT THORAX	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
FLUSHING	Cardiac disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
SCALP ERITHEMA	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
UMBILICAL MYCOSES	Infections and infestations	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
HAEMORRHAGIC CYSTITIS	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
HYPERPOTASSEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
BRONCHITIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
ARTHRALGIA	General disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
FATIGUE	General disorders	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk
MUSCOLOSKELETRICAL PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected12 at risk EG0020 events0 affected11 at risk

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004958	Estradiol
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists