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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients  with primary breast cancer who are awaiting curative-intent surgery.

Anti-tumour effects & tolerability of Faslodex alone or in combination with Arimidex in post menopausal women prior to surgery for primary breast cancer

Research Site

A double-blind, randomized, multicentre trial to compare the anti-tumour effects and tolerability of a 500 mg dose of Faslodex (fulvestrant) plus Arimidex (anastrozole) with a 500 mg dose of Faslodex(fulvestrant) alone and with Arimidex(anastrozole) alone, in postmenopausal women prior to surgery for primary breast cancer

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

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

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

AgeCategoricalOther

Gender, Male/Female

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.

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.

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.

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.

Overall Study

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.

Arms	Assigned Interventions
Active Comparator: 1 Anastrozole Monotherapy	Drug: Anastrazole oral tablet Other Name: Arimidex Other Name: ZD1033
Experimental: 2 Fulvestrant Monotherapy	Drug: Fulvestrant 500 mg intramuscular injection Other Name: Faslodex Other Name: ZD9238
Experimental: 3 Anastrozole + Fulvestrant	Drug: Fulvestrant 500 mg intramuscular injection Other Name: Faslodex Other Name: ZD9238 Drug: Anastrazole oral tablet Other Name: Arimidex Other Name: ZD1033

Anti-tumour effects & tolerability of Faslodex alone or in combination with Arimidex in post menopausal women prior to surgery for primary breast cancer

Official Title

Medical condition

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Healthy volunteers

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=408&filename=CSR-D6997C00057.pdf

CSR-D6997C00057.pdf

Trial Results Summaries

Contacts

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Investigators

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