Trial · NCT01674140

S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

NCT01674140, Phase 3, Active not recruiting, SWOG Cancer Research Network; results first posted 2023-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer. Trials, record NCT01674140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01674140

On this page

Trial

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

Title: S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
NCT number: NCT01674140
Status: Active not recruiting
Phases: Phase 3
Enrollment: 1,939 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Breast Cancer
Interventions: anastrozole, everolimus, exemestane, goserelin acetate, letrozole, leuprolide acetate, tamoxifen citrate, placebo
First posted: 2012-08-28
Last updated: 2026-10-23
Results first posted: 2023-12-20

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Invasive Disease-Free Survival (IDFS)	Up to 5 years post registration	Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. The results were presented as 5-year IDFS estimate.
Secondary	Overall Survival (OS)	5 years after last accrual	Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The results were presented as 5-year OS estimate.
Secondary	Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Every 6 weeks while on protocol therapy. Adverse events (AEs) that occurred during follow up after protocol treatment were reported as late AEs, for every 6 months for the first 2 years and then yearly until 10 years after registration.	Toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Secondary	Distant Recurrence-Free Survival (DRFS)	5 years after last accrual	Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. The results were presented as 5-year DRFS estimate.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Invasive Disease-Free Survival (IDFS)	Up to 5 years post registration	The analysis population includes the 1792 participants who were eligible and evaluable (896 per arm).	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	5 years after last accrual	The analysis population includes the 1792 participants who were eligible and evaluable (896 per arm).	percentage of participants	NUMBER
SECONDARY	Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Every 6 weeks while on protocol therapy. Adverse events (AEs) that occurred during follow up after protocol treatment were reported as late AEs, for every 6 months for the first 2 years and then yearly until 10 years after registration.	Limited to participants who started treatment, and were evaluated for toxicity assessment.	Participants	NUMBER
SECONDARY	Distant Recurrence-Free Survival (DRFS)	5 years after last accrual		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group236

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

Outcome	Group	Category	Value	Spread	Units
Invasive Disease-Free Survival (IDFS)	Placebo		74.4	95% Confidence Interval 71.1 to 77.4	percentage of participants
Invasive Disease-Free Survival (IDFS)	Everolimus		74.9	95% Confidence Interval 71.3 to 78.0	percentage of participants
Overall Survival (OS)	Placebo		85.8	95% Confidence Interval 82.9 to 88.2	percentage of participants
Overall Survival (OS)	Everolimus		88.1	95% Confidence Interval 85.3 to 90.3	percentage of participants
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Placebo	Abdominal pain	1		Participants
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Everolimus	Abdominal pain	7		Participants
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Placebo	Alanine aminotransferase increased	1		Participants
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Everolimus	Alanine aminotransferase increased	4		Participants
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Placebo	Allergic reaction	0		Participants
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.	Everolimus	Allergic reaction	2		Participants

1 to 10 of 236Source ClinicalTrials.gov

See all 236 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	968
Overall Study	STARTED	Everolimus	971
Overall Study	COMPLETED	Placebo	896
Overall Study	COMPLETED	Everolimus	896
Overall Study	NOT COMPLETED	Placebo	72
Overall Study	NOT COMPLETED	Everolimus	75

Source ClinicalTrials.gov

Adverse events426

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
other	Anemia	Blood and lymphatic system disorders	Placebo	75	881
other	Anemia	Blood and lymphatic system disorders	Everolimus	239	874
other	Abdominal pain	Gastrointestinal disorders	Placebo	64	881
other	Abdominal pain	Gastrointestinal disorders	Everolimus	70	874
other	Constipation	Gastrointestinal disorders	Placebo	122	881
other	Constipation	Gastrointestinal disorders	Everolimus	106	874
other	Diarrhea	Gastrointestinal disorders	Placebo	152	881
other	Diarrhea	Gastrointestinal disorders	Everolimus	227	874
other	Dry mouth	Gastrointestinal disorders	Placebo	53	881
other	Dry mouth	Gastrointestinal disorders	Everolimus	88	874

1 to 10 of 426Source ClinicalTrials.gov

See all 426 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	119	896
Total, all-cause mortality	Everolimus	112	896
Total, other adverse events	Placebo	798	881
Total, other adverse events	Everolimus	842	874
Total, serious adverse events	Placebo	77	881
Total, serious adverse events	Everolimus	180	874

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38833643	DERIVED	PubMed
39621968	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Everolimus vs Placebo: deaths from any cause	Trial comparisons
Everolimus vs Placebo: 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/NCT01674140

GET https://conductscience.org/api/trials/v1/NCT01674140/results?page=2

API reference For AI assistants