Trial Outcomes & Findings for Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer (NCT NCT00259090)
NCT ID: NCT00259090
Last Updated: 2012-08-16
Results Overview
For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)\]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
COMPLETED
PHASE2
120 participants
Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)
2012-08-16
Participant Flow
Postmenopausal women with oestrogen receptor positive breast cancer, awaiting curative-intent surgery were recruited to 4 medical centres within the UK.
121 patients had baseline biopsy and were randomised 1:1:1. 120 patients received 14 to 21 days therapy. Surgery was actually performed between day 13 and 28 and a tumour sample was taken. Safety data is presented for all 120 patients who received therapy. The demography data are summarized for the population who had a usable tumour sample.
Participant milestones
| Measure |
Fulvestrant
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
Anastrozole 1 mg once daily tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
37
|
|
Overall Study
COMPLETED
|
35
|
31
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant
n=35 Participants
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
n=31 Participants
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
n=37 Participants
Anastrozole 1 mg once daily tablet
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
50 - 59 years
|
7 Participants
8.5 • n=5 Participants
|
13 Participants
10.5 • n=7 Participants
|
10 Participants
8.7 • n=5 Participants
|
30 Participants
9.0 • n=4 Participants
|
|
Age, Customized
60 - 69 years
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Customized
70 - 79 years
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Customized
80 - 89 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
Not available
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)\]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
Outcome measures
| Measure |
Fulvestrant
n=35 Participants
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
n=31 Participants
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
n=37 Participants
Anastrozole 1 mg once daily tablet
|
|---|---|---|---|
|
Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.
|
-37 Percentage change from baseline
Standard Error 4
|
-38 Percentage change from baseline
Standard Error 5
|
-7 Percentage change from baseline
Standard Error 6
|
PRIMARY outcome
Timeframe: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)Population: nine patients with PgR=0 at baseline were excluded from analysis of PgR because the question of medical interest was the effect of treatment on PgR positive patients.
For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)\]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
Outcome measures
| Measure |
Fulvestrant
n=33 Participants
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
n=28 Participants
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
n=33 Participants
Anastrozole 1 mg once daily tablet
|
|---|---|---|---|
|
Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.
|
-31 Percentage change from baseline
Standard Error 8
|
-38 Percentage change from baseline
Standard Error 12
|
-38 Percentage change from baseline
Standard Error 7
|
PRIMARY outcome
Timeframe: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
Outcome measures
| Measure |
Fulvestrant
n=35 Participants
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
n=31 Participants
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
n=37 Participants
Anastrozole 1 mg once daily tablet
|
|---|---|---|---|
|
Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.
|
-62 Percentage change from baseline
Standard Error 4
|
-68 Percentage change from baseline
Standard Error 6
|
-75 Percentage change from baseline
Standard Error 4
|
Adverse Events
Fulvestrant
Fulvestrant + Anastrozole
Anastrozole
Serious adverse events
| Measure |
Fulvestrant
n=40 participants at risk
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
n=40 participants at risk
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
n=40 participants at risk
Anastrozole 1 mg once daily tablet
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/40
|
0.00%
0/40
|
2.5%
1/40
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
|
General disorders
Unevaluable Event
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/40
|
0.00%
0/40
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
Other adverse events
| Measure |
Fulvestrant
n=40 participants at risk
Fulvestrant 500 mg once monthly injection
|
Fulvestrant + Anastrozole
n=40 participants at risk
Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
|
Anastrozole
n=40 participants at risk
Anastrozole 1 mg once daily tablet
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40
|
2.5%
1/40
|
5.0%
2/40
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40
|
0.00%
0/40
|
2.5%
1/40
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
7.5%
3/40
|
5.0%
2/40
|
|
General disorders
Injection Site Rash
|
7.5%
3/40
|
0.00%
0/40
|
0.00%
0/40
|
|
General disorders
Unevaluable Event
|
7.5%
3/40
|
0.00%
0/40
|
7.5%
3/40
|
|
General disorders
Injection Site Pain
|
5.0%
2/40
|
2.5%
1/40
|
7.5%
3/40
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/40
|
10.0%
4/40
|
5.0%
2/40
|
|
Nervous system disorders
Headache
|
7.5%
3/40
|
10.0%
4/40
|
7.5%
3/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40
|
7.5%
3/40
|
0.00%
0/40
|
|
Vascular disorders
Hot Flush
|
17.5%
7/40
|
7.5%
3/40
|
20.0%
8/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AZ shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time request that submission for publication or disclosure of the manuscript be delayed for no more than an additional 45 days in order for AZ to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER