Trial Outcomes & Findings for Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer (NCT NCT00357110)
NCT ID: NCT00357110
Last Updated: 2010-12-21
Results Overview
Number of patients event-free
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
12 month period following randomisation
Results posted on
2010-12-21
Participant Flow
Participant milestones
| Measure |
Fulvestrant + Anastrozole
fulvestrant 500 mg + anastrozole 1 mg
|
Anastrozole
anastrozole 1 mg
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Fulvestrant + Anastrozole
fulvestrant 500 mg + anastrozole 1 mg
|
Anastrozole
anastrozole 1 mg
|
|---|---|---|
|
Overall Study
Early study termination
|
5
|
5
|
Baseline Characteristics
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant + Anastrozole
n=6 Participants
fulvestrant 500 mg + anastrozole 1 mg
|
Anastrozole
n=7 Participants
anastrozole 1 mg
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.5 age in years at baseline
STANDARD_DEVIATION 5.4 • n=5 Participants
|
63.4 age in years at baseline
STANDARD_DEVIATION 3.5 • n=7 Participants
|
62.1 age in years at baseline
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 month period following randomisationNumber of patients event-free
Outcome measures
| Measure |
Fulvestrant + Anastrozole
n=6 Participants
fulvestrant 500 mg + anastrozole 1 mg
|
Anastrozole
n=7 Participants
anastrozole 1 mg
|
|---|---|---|
|
Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
|
6 Participants
|
7 Participants
|
Adverse Events
Fulvestrant + Anastrozole
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Anastrozole
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fulvestrant + Anastrozole
n=6 participants at risk
fulvestrant 500 mg + anastrozole 1 mg
|
Anastrozole
n=7 participants at risk
anastrozole 1 mg
|
|---|---|---|
|
Endocrine disorders
Goitre
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Haemorrhoid Operation
|
0.00%
0/6
|
14.3%
1/7
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6
|
14.3%
1/7
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/6
|
14.3%
1/7
|
|
Vascular disorders
Varicose Vein
|
16.7%
1/6
|
0.00%
0/7
|
Other adverse events
| Measure |
Fulvestrant + Anastrozole
n=6 participants at risk
fulvestrant 500 mg + anastrozole 1 mg
|
Anastrozole
n=7 participants at risk
anastrozole 1 mg
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6
|
28.6%
2/7
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/6
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/6
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
16.7%
1/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
16.7%
1/6
|
0.00%
0/7
|
|
Vascular disorders
Flushing
|
33.3%
2/6
|
14.3%
1/7
|
|
Vascular disorders
Hot Flush
|
16.7%
1/6
|
14.3%
1/7
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
14.3%
1/7
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Unevaluable Event
|
33.3%
2/6
|
14.3%
1/7
|
|
General disorders
Fatigue
|
16.7%
1/6
|
14.3%
1/7
|
|
General disorders
Asthenia
|
16.7%
1/6
|
0.00%
0/7
|
|
General disorders
Injection Site Pruritus
|
16.7%
1/6
|
0.00%
0/7
|
|
General disorders
Oedema
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Pyrexia
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
14.3%
1/7
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
0.00%
0/7
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6
|
0.00%
0/7
|
|
Psychiatric disorders
Depressed Mood
|
16.7%
1/6
|
0.00%
0/7
|
|
Psychiatric disorders
Mood Altered
|
16.7%
1/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/6
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Seroma
|
16.7%
1/6
|
0.00%
0/7
|
|
Investigations
Weight Decreased
|
16.7%
1/6
|
0.00%
0/7
|
|
Investigations
Weight Increased
|
16.7%
1/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
16.7%
1/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal Pain
|
0.00%
0/6
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
16.7%
1/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Keratitis Herpetic
|
16.7%
1/6
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/6
|
14.3%
1/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will provide ASTRAZENECA as soon as possible with preliminary data and drafts of proposed results communications and with the proposed final draft at least 14 days prior to submission of an abstract and 30 days prior to submission of a manuscript. ASTRAZENECA can, upon written request, embargo communications regarding trial results for no more than 45 days from the date of the written request. ASTRAZENECA cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER