Trial Outcomes & Findings for E3 Breast Cancer Taxotere Combination (NCT NCT00494481)
NCT ID: NCT00494481
Last Updated: 2016-09-30
Results Overview
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Results posted on
2016-09-30
Participant Flow
First patient randomised 03 February 2006, last patient randomised 25 April 2007, data cut off data 23 June 2007
Participant milestones
| Measure |
Vandetanib Plus Docetaxel
vandetanib 100 mg plus docetaxel
|
Placebo Plus Docetaxel
placebo plus docetaxel
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
29
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
29
|
24
|
Reasons for withdrawal
| Measure |
Vandetanib Plus Docetaxel
vandetanib 100 mg plus docetaxel
|
Placebo Plus Docetaxel
placebo plus docetaxel
|
|---|---|---|
|
Overall Study
Condition under investigation worsened
|
11
|
13
|
|
Overall Study
Adverse Event
|
15
|
11
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Never received IP
|
2
|
0
|
Baseline Characteristics
E3 Breast Cancer Taxotere Combination
Baseline characteristics by cohort
| Measure |
Vandetanib Plus Docetaxel
n=35 Participants
vandetanib 100 mg plus docetaxel
|
Placebo Plus Docetaxel
n=29 Participants
placebo plus docetaxel
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 Years
n=93 Participants
|
57 Years
n=4 Participants
|
55.5 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-offNumber of patients with objective disease progression or death (by any cause in the absence of objective progression)
Outcome measures
| Measure |
Vandetanib Plus Docetaxel
n=35 Participants
vandetanib 100 mg plus docetaxel
|
Placebo Plus Docetaxel
n=29 Participants
placebo plus docetaxel
|
|---|---|---|
|
Number of Patients With a Disease Progression Event
|
24 Participants
|
18 Participants
|
Adverse Events
Vandetanib Plus Docetaxel
Serious events: 14 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo Plus Docetaxel
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib Plus Docetaxel
n=33 participants at risk
vandetanib 100 mg plus docetaxel
|
Placebo Plus Docetaxel
n=29 participants at risk
placebo plus docetaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
12.1%
4/33
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
3/33
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/33
|
3.4%
1/29
|
|
Cardiac disorders
Atrial Fibrillation
|
3.0%
1/33
|
3.4%
1/29
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
1/33
|
0.00%
0/29
|
|
Eye disorders
Keratitis
|
3.0%
1/33
|
0.00%
0/29
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
3/33
|
0.00%
0/29
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33
|
3.4%
1/29
|
|
Gastrointestinal disorders
Ileus
|
3.0%
1/33
|
0.00%
0/29
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33
|
0.00%
0/29
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33
|
0.00%
0/29
|
|
General disorders
Asthenia
|
3.0%
1/33
|
0.00%
0/29
|
|
General disorders
Fatigue
|
3.0%
1/33
|
0.00%
0/29
|
|
General disorders
Pyrexia
|
0.00%
0/33
|
3.4%
1/29
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/33
|
6.9%
2/29
|
|
Infections and infestations
Cellulitis
|
3.0%
1/33
|
0.00%
0/29
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/33
|
3.4%
1/29
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33
|
3.4%
1/29
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/33
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
1/33
|
0.00%
0/29
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/33
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33
|
10.3%
3/29
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/33
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
3.0%
1/33
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
3.0%
1/33
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Toxic Epidermal Necrolysis
|
3.0%
1/33
|
0.00%
0/29
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/33
|
3.4%
1/29
|
|
Vascular disorders
Hypertension
|
3.0%
1/33
|
0.00%
0/29
|
Other adverse events
| Measure |
Vandetanib Plus Docetaxel
n=33 participants at risk
vandetanib 100 mg plus docetaxel
|
Placebo Plus Docetaxel
n=29 participants at risk
placebo plus docetaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
45.5%
15/33
|
44.8%
13/29
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.3%
10/33
|
27.6%
8/29
|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
6/33
|
20.7%
6/29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.1%
4/33
|
0.00%
0/29
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
3/33
|
0.00%
0/29
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
3/33
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
6.1%
2/33
|
6.9%
2/29
|
|
Ear and labyrinth disorders
Vertigo
|
6.1%
2/33
|
3.4%
1/29
|
|
Eye disorders
Lacrimation Increased
|
6.1%
2/33
|
24.1%
7/29
|
|
Eye disorders
Conjunctivitis
|
6.1%
2/33
|
10.3%
3/29
|
|
Eye disorders
Vision Blurred
|
0.00%
0/33
|
6.9%
2/29
|
|
Gastrointestinal disorders
Stomatitis
|
48.5%
16/33
|
41.4%
12/29
|
|
Gastrointestinal disorders
Diarrhoea
|
39.4%
13/33
|
41.4%
12/29
|
|
Gastrointestinal disorders
Nausea
|
27.3%
9/33
|
34.5%
10/29
|
|
Gastrointestinal disorders
Abdominal Pain
|
18.2%
6/33
|
17.2%
5/29
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
3/33
|
20.7%
6/29
|
|
Gastrointestinal disorders
Constipation
|
15.2%
5/33
|
6.9%
2/29
|
|
Gastrointestinal disorders
Dry Mouth
|
12.1%
4/33
|
3.4%
1/29
|
|
Gastrointestinal disorders
Cheilitis
|
3.0%
1/33
|
10.3%
3/29
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
3/33
|
10.3%
3/29
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33
|
3.4%
1/29
|
|
Gastrointestinal disorders
Gastritis
|
6.1%
2/33
|
6.9%
2/29
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/33
|
6.9%
2/29
|
|
Gastrointestinal disorders
Odynophagia
|
6.1%
2/33
|
0.00%
0/29
|
|
General disorders
Fatigue
|
33.3%
11/33
|
24.1%
7/29
|
|
General disorders
Asthenia
|
9.1%
3/33
|
27.6%
8/29
|
|
General disorders
Oedema Peripheral
|
21.2%
7/33
|
20.7%
6/29
|
|
General disorders
Pyrexia
|
15.2%
5/33
|
10.3%
3/29
|
|
General disorders
Face Oedema
|
3.0%
1/33
|
6.9%
2/29
|
|
General disorders
Influenza Like Illness
|
3.0%
1/33
|
6.9%
2/29
|
|
General disorders
Malaise
|
6.1%
2/33
|
0.00%
0/29
|
|
General disorders
Performance Status Decreased
|
6.1%
2/33
|
0.00%
0/29
|
|
Infections and infestations
Pharyngitis
|
6.1%
2/33
|
10.3%
3/29
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/33
|
10.3%
3/29
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/33
|
6.9%
2/29
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33
|
3.4%
1/29
|
|
Infections and infestations
Oral Candidiasis
|
3.0%
1/33
|
6.9%
2/29
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
2/33
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Chemical Eye Injury
|
6.1%
2/33
|
6.9%
2/29
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
9.1%
3/33
|
6.9%
2/29
|
|
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
|
6.1%
2/33
|
6.9%
2/29
|
|
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
|
6.1%
2/33
|
6.9%
2/29
|
|
Injury, poisoning and procedural complications
Blood Alkaline Phosphatase Increased
|
6.1%
2/33
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Anorexia
|
21.2%
7/33
|
31.0%
9/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.3%
10/33
|
31.0%
9/29
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/33
|
13.8%
4/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.1%
2/33
|
10.3%
3/29
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
1/33
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.1%
2/33
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.0%
1/33
|
6.9%
2/29
|
|
Nervous system disorders
Paraesthesia
|
12.1%
4/33
|
31.0%
9/29
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
18.2%
6/33
|
10.3%
3/29
|
|
Nervous system disorders
Dysgeusia
|
15.2%
5/33
|
13.8%
4/29
|
|
Nervous system disorders
Headache
|
12.1%
4/33
|
13.8%
4/29
|
|
Nervous system disorders
Hypoaesthesia
|
12.1%
4/33
|
10.3%
3/29
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33
|
6.9%
2/29
|
|
Nervous system disorders
Lethargy
|
9.1%
3/33
|
10.3%
3/29
|
|
Nervous system disorders
Neurotoxicity
|
6.1%
2/33
|
3.4%
1/29
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33
|
6.9%
2/29
|
|
Psychiatric disorders
Depression
|
6.1%
2/33
|
3.4%
1/29
|
|
Renal and urinary disorders
Dysuria
|
6.1%
2/33
|
3.4%
1/29
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/33
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.2%
8/33
|
10.3%
3/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
6/33
|
13.8%
4/29
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
15.2%
5/33
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.1%
4/33
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.1%
2/33
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.5%
17/33
|
37.9%
11/29
|
|
Skin and subcutaneous tissue disorders
Erythema
|
21.2%
7/33
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
18.2%
6/33
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.2%
5/33
|
17.2%
5/29
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
15.2%
5/33
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
6.1%
2/33
|
17.2%
5/29
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
9.1%
3/33
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.1%
3/33
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
9.1%
3/33
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Nail Pigmentation
|
9.1%
3/33
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
9.1%
3/33
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
3.0%
1/33
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
9.1%
3/33
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
6.1%
2/33
|
6.9%
2/29
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
6.1%
2/33
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
6.1%
2/33
|
0.00%
0/29
|
|
Vascular disorders
Hypertension
|
15.2%
5/33
|
0.00%
0/29
|
|
Vascular disorders
Flushing
|
6.1%
2/33
|
6.9%
2/29
|
|
Vascular disorders
Hot Flush
|
0.00%
0/33
|
6.9%
2/29
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/33
|
6.9%
2/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER