Trial · NCT00259090
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
NCT00259090, Phase 2, Completed, AstraZeneca; results first posted 2012-08-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer. Trials, record NCT00259090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00259090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
- NCT number
- NCT00259090
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Breast Cancer
- Interventions
- Fulvestrant, Anastrazole
- First posted
- 2005-11-29
- Last updated
- 2012-08-16
- Results first posted
- 2012-08-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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 |
| Primary | 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. | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) | 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 |
| Primary | 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. | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) | Percentage change from baseline | MEAN | |
| PRIMARY | 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. | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) | 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 | MEAN |
| PRIMARY | 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. | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) | Percentage change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Fulvestrant | -37 | Standard Error 4 | Percentage change from baseline | |
| 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. | Fulvestrant + Anastrozole | -38 | Standard Error 5 | Percentage change from baseline | |
| 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. | Anastrozole | -7 | Standard Error 6 | Percentage change from baseline | |
| 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. | Fulvestrant | -31 | Standard Error 8 | Percentage change from baseline | |
| 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. | Fulvestrant + Anastrozole | -38 | Standard Error 12 | Percentage change from baseline | |
| 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. | Anastrozole | -38 | Standard Error 7 | Percentage change from baseline | |
| 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. | Fulvestrant | -62 | Standard Error 4 | Percentage change from baseline | |
| 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. | Fulvestrant + Anastrozole | -68 | Standard Error 6 | Percentage change from baseline | |
| 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. | Anastrozole | -75 | Standard Error 4 | Percentage change from baseline |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fulvestrant | 35 | |
| Overall Study | STARTED | Fulvestrant + Anastrozole | 31 | |
| Overall Study | STARTED | Anastrozole | 37 | |
| Overall Study | COMPLETED | Fulvestrant | 35 | |
| Overall Study | COMPLETED | Fulvestrant + Anastrozole | 31 | |
| Overall Study | COMPLETED | Anastrozole | 37 | |
| Overall Study | NOT COMPLETED | Fulvestrant | 0 | |
| Overall Study | NOT COMPLETED | Fulvestrant + Anastrozole | 0 | |
| Overall Study | NOT COMPLETED | Anastrozole | 0 |
Source ClinicalTrials.gov
Adverse events45
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Fulvestrant | 3 | 40 | |
| other | Constipation | Gastrointestinal disorders | Fulvestrant + Anastrozole | 1 | 40 | |
| other | Constipation | Gastrointestinal disorders | Anastrozole | 2 | 40 | |
| other | Dyspepsia | Gastrointestinal disorders | Fulvestrant | 3 | 40 | |
| other | Dyspepsia | Gastrointestinal disorders | Fulvestrant + Anastrozole | 0 | 40 | |
| other | Dyspepsia | Gastrointestinal disorders | Anastrozole | 1 | 40 | |
| other | Nausea | Gastrointestinal disorders | Fulvestrant | 0 | 40 | |
| other | Nausea | Gastrointestinal disorders | Fulvestrant + Anastrozole | 3 | 40 | |
| other | Nausea | Gastrointestinal disorders | Anastrozole | 2 | 40 | |
| other | Injection Site Rash | General disorders | Fulvestrant | 3 | 40 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fulvestrant | ||
| Total, all-cause mortality | Fulvestrant + Anastrozole | ||
| Total, all-cause mortality | Anastrozole | ||
| Total, other adverse events | Fulvestrant | 18 | 40 |
| Total, other adverse events | Fulvestrant + Anastrozole | 13 | 40 |
| Total, other adverse events | Anastrozole | 17 | 40 |
| Total, serious adverse events | Fulvestrant | 0 | 40 |
| Total, serious adverse events | Fulvestrant + Anastrozole | 3 | 40 |
| Total, serious adverse events | Anastrozole | 2 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23497452 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00259090
GET https://conductscience.org/api/trials/v1/NCT00259090/events?page=2