18 and older, female only, with Invasive Breast Carcinoma or Recurrent Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free SurvivalPrimary· 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 targ
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
20.2
17 – 24
Arm II (Endocrine Therapy)
15.6
12.9 – 19.7
12 Month Progression Free Survival RateSecondary· 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.
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
73
66 – 80
Arm II (Endocrine Therapy)
61
54 – 68
6 Month Progression-Free Survival RateSecondary· 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.
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
87
82 – 93
Arm II (Endocrine Therapy)
77
71 – 83
Objective Response RateSecondary· 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.
Complete Response (CR)
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
4
Arm II (Endocrine Therapy)
7
Partial Response (PR)
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
65
Arm II (Endocrine Therapy)
42
Stable Disease (SD)
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
22
Arm II (Endocrine Therapy)
34
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Arm I (Endocrine Therapy With Monoclonal Antibody)
47.2
39 – 56.8
Arm II (Endocrine Therapy)
43.9
37.6 – 49.6
Adverse events — posted to ClinicalTrials.gov
Time frame: All patients that received study treatment and were analyzed for adverse events are included in this summary..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm I (Endocrine Therapy With Monoclonal Antibody)
Serious: 56/195 (29%)
Deaths: —
Arm II (Endocrine Therapy)
Serious: 30/196 (15%)
Deaths: —
Serious adverse events (103 terms)
Reaction
System
Arm I (Endocrine Therapy W…
Arm II (Endocrine Therapy)
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
Hypertension
Vascular disorders
—
—
Proteinuria
Renal and urinary disorders
—
—
Headache
Nervous system disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Fever
General disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
—
Anorexia
Metabolism and nutrition disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Disease progression
General disorders
—
—
Fatigue
General disorders
—
—
Wound infection
Infections and infestations
—
—
Alkaline phosphatase increased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Serum sodium decreased
Metabolism and nutrition disorders
—
—
Muscle weakness
Musculoskeletal and connective tissue disorders
—
—
Syncope
Nervous system disorders
—
—
Renal failure
Renal and urinary disorders
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
Thrombosis
Vascular disorders
—
—
Hemoglobin decreased
Blood and lymphatic system disorders
—
—
Left ventricular failure
Cardiac disorders
—
—
Other adverse events (149 terms — click to expand)
This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00601900.