Trial · NCT00295620

Secondary Adjuvant Long Term Study With Arimidex

NCT00295620, Phase 3, Completed, AstraZeneca; results first posted 2019-10-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Secondary Adjuvant Long Term Study With Arimidex. Trials, record NCT00295620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00295620

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Secondary Adjuvant Long Term Study With Arimidex
NCT number: NCT00295620
Status: Completed
Phases: Phase 3
Enrollment: 3,484 participants, actual
Lead sponsor: AstraZeneca
Conditions: Breast Cancer
Interventions: Anastrozole
First posted: 2006-02-24
Last updated: 2019-10-02
Results first posted: 2019-10-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival After Prolonged Endocrine Treatment	DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years	To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.
Secondary	Overall Survival After Prolonged Endocrine Treatment	Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years	To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival.
Secondary	Time to First Clinical Fracture	Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.	To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization).
Secondary	Time to Secondary Carcinoma	Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years	To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free.
Secondary	Time to Contralateral Breast Cancer	Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years	To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival After Prolonged Endocrine Treatment	DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years	Per-Protocol (PP) Population, defined as all randomized patients who signed the informed consent who complied with the inclusion and exclusion criteria, who had at least one follow-up examination after randomization and who survived without recurrence for two years.	Years	MEDIAN
SECONDARY	Overall Survival After Prolonged Endocrine Treatment	Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years	All randomized patients who signed the informed consent and who did not die during two first two years	Years	MEDIAN
SECONDARY	Time to First Clinical Fracture	Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.	All randomized patients who signed the informed consent and who had no fractures during the first two years	Years	MEDIAN
SECONDARY	Time to Secondary Carcinoma	Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years	All randomized patients who signed the informed consent and had no secondary carcinoma (excluding contralateral mammacarcinoma) during the first two years	Years	MEDIAN
SECONDARY	Time to Contralateral Breast Cancer	Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years	All randomized patients who signed the informed consent and had no contralateral mammacarcinoma during the first two years	Years	MEDIAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease-free Survival After Prolonged Endocrine Treatment	Arm A: Anastrozol	NA	Inter-Quartile Range 7.7 to NA	Years
Disease-free Survival After Prolonged Endocrine Treatment	Arm B: Anastrozol	NA	Inter-Quartile Range 8.1 to NA	Years
Overall Survival After Prolonged Endocrine Treatment	Arm A: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Overall Survival After Prolonged Endocrine Treatment	Arm B: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Time to First Clinical Fracture	Arm A: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Time to First Clinical Fracture	Arm B: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Time to Secondary Carcinoma	Arm A: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Time to Secondary Carcinoma	Arm B: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Time to Contralateral Breast Cancer	Arm A: Anastrozol	NA	Inter-Quartile Range NA to NA	Years
Time to Contralateral Breast Cancer	Arm B: Anastrozol	NA	Inter-Quartile Range NA to NA	Years

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Anastrozol	1,732
Overall Study	STARTED	Arm B: Anastrozol	1,738
Overall Study	Safety Analysis Set	Arm A: Anastrozol	1,705
Overall Study	Safety Analysis Set	Arm B: Anastrozol	1,710
Overall Study	COMPLETED	Arm A: Anastrozol	860
Overall Study	COMPLETED	Arm B: Anastrozol	842
Overall Study	NOT COMPLETED	Arm A: Anastrozol	872
Overall Study	NOT COMPLETED	Arm B: Anastrozol	896

Source ClinicalTrials.gov

Adverse events1,550

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
serious	Anaemia	Blood and lymphatic system disorders	Arm B: Anastrozol - 1 mg Per Day for 5 Years	1	1,710	2
serious	Anaemia	Blood and lymphatic system disorders	Arm A: Anastrozol - 1 mg Per Day for 2 Years	1	1,705	2
serious	Anaemia macrocytic	Blood and lymphatic system disorders	Arm B: Anastrozol - 1 mg Per Day for 5 Years	0	1,710	0
serious	Anaemia macrocytic	Blood and lymphatic system disorders	Arm A: Anastrozol - 1 mg Per Day for 2 Years	1	1,705	2
serious	Bone marrow oedema	Blood and lymphatic system disorders	Arm B: Anastrozol - 1 mg Per Day for 5 Years	3	1,710	3
serious	Bone marrow oedema	Blood and lymphatic system disorders	Arm A: Anastrozol - 1 mg Per Day for 2 Years	0	1,705	0
serious	Haemolytic anaemia	Blood and lymphatic system disorders	Arm B: Anastrozol - 1 mg Per Day for 5 Years	1	1,710	1
serious	Haemolytic anaemia	Blood and lymphatic system disorders	Arm A: Anastrozol - 1 mg Per Day for 2 Years	0	1,705	0
serious	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	Arm B: Anastrozol - 1 mg Per Day for 5 Years	1	1,710	2
serious	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	Arm A: Anastrozol - 1 mg Per Day for 2 Years	0	1,705	0

1 to 10 of 1,550Source ClinicalTrials.gov

See all 1,550 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm B: Anastrozol - 1 mg Per Day for 5 Years	207	1,738
Total, all-cause mortality	Arm A: Anastrozol - 1 mg Per Day for 2 Years	207	1,732
Total, other adverse events	Arm B: Anastrozol - 1 mg Per Day for 5 Years	0	1,710
Total, other adverse events	Arm A: Anastrozol - 1 mg Per Day for 2 Years	0	1,705
Total, serious adverse events	Arm B: Anastrozol - 1 mg Per Day for 5 Years	687	1,710
Total, serious adverse events	Arm A: Anastrozol - 1 mg Per Day for 2 Years	452	1,705

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34320285	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm B: Anastrozol - 1 mg Per Day for 5 Years vs Arm A: Anastrozol - 1 mg Per Day for 2 Years: deaths from any cause	Trial comparisons
Arm B: Anastrozol - 1 mg Per Day for 5 Years vs Arm A: Anastrozol - 1 mg Per Day for 2 Years: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00295620

GET https://conductscience.org/api/trials/v1/NCT00295620/events?page=2

API reference For AI assistants