Trial · NCT00601900
Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer
NCT00601900, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2016-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer. Trials, record NCT00601900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601900
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer
- NCT number
- NCT00601900
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 394 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v6, Stage IV Breast Cancer AJCC v6 and v7
- Interventions
- Bevacizumab, Laboratory Biomarker Analysis, Letrozole, Questionnaire Administration, Tamoxifen Citrate
- First posted
- 2008-01-28
- Last updated
- 2026-08-28
- Results first posted
- 2016-08-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From randomization until disease progression or death whichever occurs first, assessed up to 5 years | The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions. |
| Secondary | 12 Month Progression Free Survival Rate | At 12 months | The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study. |
| Secondary | 6 Month Progression-Free Survival Rate | At 6 months | The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study. |
| Secondary | Objective Response Rate | Assessed up to 5 years | Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions. |
| Secondary | Overall Survival (OS) | Assessed up to 5 years | OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method. |
| Secondary | Duration of Tumor Response | 5 years | Defined as the time from PR or CR, whichever comes first and by RECIST criteria, to progression or death. |
| Secondary | Overall Survival (OS) at 36 Months | 36 months | Proportion of patients surviving until 36 months |
| Secondary | Clinical Benefit Rate (CBR) | 5 years | To compare the rate of clinical benefit (CR + PR + stable disease ≥ 6 months) in patients receiving letrozole with and without bevacizumab. |
| Secondary | Time-to-treatment Failure | 5 years | From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure |
| Secondary | Grade 3 or Higher Treatment Related Toxicity | 5 years | Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Events occuring in 5 percent or more of evaluable patients will be tabulated. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From randomization until disease progression or death whichever occurs first, assessed up to 5 years | Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint. | months | MEDIAN |
| SECONDARY | 12 Month Progression Free Survival Rate | At 12 months | Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint. | percentage of participants | NUMBER |
| SECONDARY | 6 Month Progression-Free Survival Rate | At 6 months | Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate | Assessed up to 5 years | Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Assessed up to 5 years | Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint. | months | MEDIAN |
| SECONDARY | Duration of Tumor Response | From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | |||
| SECONDARY | Probability of Surviving Until 36 Months | At 36 months | |||
| SECONDARY | Site of Progression | Up to 5 years | |||
| SECONDARY | Time-to-treatment Failure | Up to 5 years | |||
| SECONDARY | Treatment Related Toxicity | Up to 5 years |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Arm I (Endocrine Therapy With Monoclonal Antibody) | 20.2 | 95% Confidence Interval 17 to 24 | months | |
| Progression-free Survival | Arm II (Endocrine Therapy) | 15.6 | 95% Confidence Interval 12.9 to 19.7 | months | |
| 12 Month Progression Free Survival Rate | Arm I (Endocrine Therapy With Monoclonal Antibody) | 73 | 95% Confidence Interval 66 to 80 | percentage of participants | |
| 12 Month Progression Free Survival Rate | Arm II (Endocrine Therapy) | 61 | 95% Confidence Interval 54 to 68 | percentage of participants | |
| 6 Month Progression-Free Survival Rate | Arm I (Endocrine Therapy With Monoclonal Antibody) | 87 | 95% Confidence Interval 82 to 93 | percentage of participants | |
| 6 Month Progression-Free Survival Rate | Arm II (Endocrine Therapy) | 77 | 95% Confidence Interval 71 to 83 | percentage of participants | |
| Objective Response Rate | Arm I (Endocrine Therapy With Monoclonal Antibody) | Complete Response (CR) | 4 | percentage of participants | |
| Objective Response Rate | Arm II (Endocrine Therapy) | Complete Response (CR) | 7 | percentage of participants | |
| Objective Response Rate | Arm I (Endocrine Therapy With Monoclonal Antibody) | Partial Response (PR) | 65 | percentage of participants | |
| Objective Response Rate | Arm II (Endocrine Therapy) | Partial Response (PR) | 42 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Endocrine Therapy With Monoclonal Antibody) | 195 | |
| Overall Study | STARTED | Arm II (Endocrine Therapy) | 199 | |
| Overall Study | COMPLETED | Arm I (Endocrine Therapy With Monoclonal Antibody) | 195 | |
| Overall Study | COMPLETED | Arm II (Endocrine Therapy) | 196 | |
| Overall Study | NOT COMPLETED | Arm I (Endocrine Therapy With Monoclonal Antibody) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Endocrine Therapy) | 3 |
Source ClinicalTrials.gov
Adverse events504
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 | Blood disorder | Blood and lymphatic system disorders | Arm I (Endocrine Therapy With Monoclonal Antibody) | 0 | 195 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm II (Endocrine Therapy) | 1 | 196 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (Endocrine Therapy With Monoclonal Antibody) | 5 | 195 | 12 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (Endocrine Therapy) | 2 | 196 | 2 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (Endocrine Therapy With Monoclonal Antibody) | 2 | 195 | 2 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (Endocrine Therapy) | 0 | 196 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Arm I (Endocrine Therapy With Monoclonal Antibody) | 1 | 195 | 16 |
| other | Atrial fibrillation | Cardiac disorders | Arm II (Endocrine Therapy) | 0 | 196 | 0 |
| other | Cardiac valve disease | Cardiac disorders | Arm I (Endocrine Therapy With Monoclonal Antibody) | 0 | 195 | 0 |
| other | Cardiac valve disease | Cardiac disorders | Arm II (Endocrine Therapy) | 1 | 196 | 2 |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Endocrine Therapy With Monoclonal Antibody) | ||
| Total, all-cause mortality | Arm II (Endocrine Therapy) | ||
| Total, other adverse events | Arm I (Endocrine Therapy With Monoclonal Antibody) | 174 | 195 |
| Total, other adverse events | Arm II (Endocrine Therapy) | 145 | 196 |
| Total, serious adverse events | Arm I (Endocrine Therapy With Monoclonal Antibody) | 56 | 195 |
| Total, serious adverse events | Arm II (Endocrine Therapy) | 30 | 196 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Endocrine Therapy With Monoclonal Antibody) vs Arm II (Endocrine Therapy): 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/NCT00601900
GET https://conductscience.org/api/trials/v1/NCT00601900/events?page=2