This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments paclitaxel, bevacizumab, letrozole, anastrozole, exemestane, fulvestrant, goserelin, leuprorelin, lhrh analogs + aromatase inhibitors
Phase phase 2
Target VEGF
Sponsor Japan Breast Cancer Research Group
Collaborator Chugai Pharmaceutical
Start date January 2014
End date June 2018
Trial size 160 participants
Trial identifier NCT01989780, JBCRG-M04


To evaluate optimal usage of bevacizumab to compare which is better, continuing bevacizumab and paclitaxel or switching to hormonal maintenance therapy followed by bevacizumab+paclitaxel after induction therapy of bevacizumab+paclitaxel.

To examine biomarkers such as monitoring markers of study treatment as exploratory analysis.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
(Active Comparator)
weekly paclitaxel + bevacizumab
paclitaxel Taxol
bevacizumab Avastin
weekly paclitaxel + bevacizumab followed by hormone therapy(Treatment of physician's choice)* + bevacizumab then back to weekly paclitaxel + bevacizumab * Letrozole, Anastrozole, Exemestane, Fulvestrant, Goserelin, leuprorelin or LHRH Analogs + Aromatase inhibitors.
paclitaxel Taxol
bevacizumab Avastin
letrozole Femara
anastrozole Arimidex
exemestane Aromasin
fulvestrant Faslodex
goserelin Zoladex
leuprorelin Leuplin
lhrh analogs + aromatase inhibitors Zoladex or Leuplin + Femara or Arimidex or Aromasin

Primary Outcomes

Time to failure of strategy (TFS)
time frame: 3.5 years

Secondary Outcomes

2y Overall Survival rate
time frame: 3.5 years
Overall Survival
time frame: 3.5years
Progression Free Survival(PFS)
time frame: 3.5years
time frame: 3.5years
Biomarker(IMPACT assay Chips, whole blood, tumor tissue, Serum)
time frame: 3.5years
Safety(Collection of adverse events)
time frame: 3.5years

Eligibility Criteria

Female participants from 20 years up to 75 years old.

Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the breast 2. Female aged 20-75 years old at getting informed consent 3. HER2 negative disease (IHC 0/1+ or 2+ with FISH negative) 4. Documented estrogen receptor (ER) positive (>=1% by IHC) 5. Inoperative locally advanced or metastatic breast cancer at enrolment 6. Performance status (ECOG): 0-1 at enrolment 7. Life expectancy of at least 3 months from enrolment 8. No prior systemic therapy for recurrent breast cancer (excluding hormone therapy) 9. No prior neo and/or adjuvant chemotherapy with taxane or adjuvant setting with a disease-free interval from completion of the taxane treatment to metastatic diagnosis of >= 12 months 10. Patients with measurable lesion regarding with Response Evaluation Criteria in Solid Tumors(RECIST) criteria or who have evaluable lesion 11. Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT 12. No influence on protocol treatment is considered in case prior therapy or examination. 13. Adequate following organ function within 2 weeks before starting treatment. The latest examination results should be adopted and blood transfusion or treatment of hematopoietic factor drugs is not allowed 2 weeks before examination. - Absolute neutrophil count >= 1500 /mm3 or white blood cell(WBC) count >= 3000 /mm3 - Platelets >=10 x 10000 /mm3 - Hb >= 9 g/dL - Total bilirubin <= 1.5 mg/dL - aspartate aminotransferase(AST) and alanine aminotransferase(ALT) <= 100 international unit(IU)/L - Serum creatinine <= 1.5 mg/dL - Urine dipstick for proteinuria <= 1+ 14. Written informed consent signed by patients before completing any treatment related procedure Exclusion Criteria: 1. Prior therapy with bevacizumab 2. Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV. 3. Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period. 4. Known hypersensitivity to bevacizumab or paclitaxel 5. History of hemoptysis (>= 2.5mL of bright red blood per episord). 6. Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride 7. Patients with CNS metastases (except for not symptomatic) 8. Persistent Grade >= 2 sensory neuropathy at enrollment 9. Grade 3 >= hypertension (>= 2 use of antihypertensive drug) 10. Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment. 11. Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment. 12. History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment 13. Cases that the investigator judged as inappropriate as the subject of this clinical study

Additional Information

Official title Bevacizumab Plus Paclitaxel Optimization Study With Interventional Maintenance Endocrine Therapy in Advanced or Metastatic ER-positive HER2-negative Breast Cancer -BOOSTER Trial, a Multicenter Randomized Phase II Study-
Principal investigator Masakazu Toi, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Japan Breast Cancer Research Group.