Trial · NCT00726661
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
NCT00726661, Completed, Genentech, Inc.; results first posted 2016-06-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO). Trials, record NCT00726661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00726661
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
- NCT number
- NCT00726661
- Status
- Completed
- Enrollment
- 1,287 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Breast Cancer
- First posted
- 2008-08-01
- Last updated
- 2017-07-11
- Results first posted
- 2016-06-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Approximately 4.5 years | Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method. |
| Secondary | Overall Survival | Approximately 4.5 years | Overall survival was defined as the time from enrolment to death of any cause. |
| Secondary | Number of Participants With Tumor Response | Approximately 4.5 years | The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method. |
| Secondary | Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation | Approximately 4.5 years | Participants were assessed quarterly for progressive events and treatment status. |
| Secondary | Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death | Approximately 4.5 years | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. |
| Secondary | Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy | Approximately 4.5 years | All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | Approximately 4.5 years | All enrolled participants were considered for this outcome measure. | months | MEDIAN |
| SECONDARY | Overall Survival | Approximately 4.5 years | All enrolled participants were considered for this outcome measure. | months | MEDIAN |
| SECONDARY | Number of Participants With Tumor Response | Approximately 4.5 years | All enrolled participants were considered for this outcome measure. | participants | NUMBER |
| SECONDARY | Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation | Approximately 4.5 years | All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point. | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death | Approximately 4.5 years | All enrolled participants were considered for this outcome measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy | Approximately 4.5 years | All enrolled participants were considered for this outcome measure. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Chemotherapy Cohort | 8.54 | 95% Confidence Interval 8.02 to 9.20 | months | |
| Progression Free Survival | Hormonal Therapy Cohort | 12.88 | 95% Confidence Interval 10.81 to 14.69 | months | |
| Overall Survival | Chemotherapy Cohort | 23.92 | 95% Confidence Interval 22.24 to 26.71 | months | |
| Overall Survival | Hormonal Therapy Cohort | 44.78 | 95% Confidence Interval 39.85 to NA | months | |
| Number of Participants With Tumor Response | Chemotherapy Cohort | Complete response | 133 | participants | |
| Number of Participants With Tumor Response | Hormonal Therapy Cohort | Complete response | 34 | participants | |
| Number of Participants With Tumor Response | Chemotherapy Cohort | Partial response | 259 | participants | |
| Number of Participants With Tumor Response | Hormonal Therapy Cohort | Partial response | 107 | participants | |
| Number of Participants With Tumor Response | Chemotherapy Cohort | Stable disease | 226 | participants | |
| Number of Participants With Tumor Response | Hormonal Therapy Cohort | Stable disease | 180 | participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy Cohort | 832 | |
| Overall Study | STARTED | Hormonal Therapy Cohort | 435 | |
| Overall Study | COMPLETED | Chemotherapy Cohort | 18 | |
| Overall Study | COMPLETED | Hormonal Therapy Cohort | 17 | |
| Overall Study | NOT COMPLETED | Chemotherapy Cohort | 814 | |
| Overall Study | NOT COMPLETED | Hormonal Therapy Cohort | 418 |
Source ClinicalTrials.gov
Adverse events300
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 | Left ventricular systolic dysfunction (Grade >=2) | Cardiac disorders | Chemotherapy Cohort | 5 | 832 | |
| other | Left ventricular systolic dysfunction (Grade >=2) | Cardiac disorders | Hormonal Therapy Cohort | 3 | 435 | |
| other | Congestive heart failure | Cardiac disorders | Chemotherapy Cohort | 1 | 832 | |
| other | Congestive heart failure | Cardiac disorders | Hormonal Therapy Cohort | 0 | 435 | |
| other | Decreased ejection fraction | Cardiac disorders | Chemotherapy Cohort | 1 | 832 | |
| other | Decreased ejection fraction | Cardiac disorders | Hormonal Therapy Cohort | 0 | 435 | |
| other | Anemia | Blood and lymphatic system disorders | Chemotherapy Cohort | 1 | 832 | |
| other | Anemia | Blood and lymphatic system disorders | Hormonal Therapy Cohort | 0 | 435 | |
| other | Bicytopenia | Blood and lymphatic system disorders | Chemotherapy Cohort | 1 | 832 | |
| other | Bicytopenia | Blood and lymphatic system disorders | Hormonal Therapy Cohort | 0 | 435 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy Cohort | ||
| Total, all-cause mortality | Hormonal Therapy Cohort | ||
| Total, other adverse events | Chemotherapy Cohort | 46 | 832 |
| Total, other adverse events | Hormonal Therapy Cohort | 13 | 435 |
| Total, serious adverse events | Chemotherapy Cohort | 76 | 832 |
| Total, serious adverse events | Hormonal Therapy Cohort | 22 | 435 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Chemotherapy Cohort vs Hormonal Therapy Cohort: serious adverse events |
Source 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.
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/NCT00726661
GET https://conductscience.org/api/trials/v1/NCT00726661/results?page=2