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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01989780
Other study ID # JBCRG-M04
Secondary ID UMIN000012179
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2014
Est. completion date June 2019

Study information

Verified date July 2019
Source Japan Breast Cancer Research Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.


Description:

This multicenter, randomized Phase II study of patients with advanced or metastatic estrogen receptor-positive human epidermal receptor type 2-negative breast cancer aims to compare two treatment strategies following induction therapy with 4-6 cycles of the combined use of weekly paclitaxel (wPTX) and bevacizumab (BV). In arm A, wPTX+BV is continued, while in arm B, wPTX is switched to maintenance endocrine therapy (hormone+BV) until disease progression, followed by wPTX+BV re-induction. The primary endpoint is time to failure of strategy, which is the time from randomization to a qualifying event (addition of a new agent not in the primary regimen, progressive disease during or after planned therapy, or death).


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 2019
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel

Bevacizumab

Letrozole

Anastrozole

Exemestane

Fulvestrant

Goserelin

leuprorelin


Locations

Country Name City State
Japan Japan Breast Cancer Research Group Chuo-ku, Nihonbashi, Koami-cho Tokyo

Sponsors (2)

Lead Sponsor Collaborator
Japan Breast Cancer Research Group Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to failure of strategy (TFS) 2.5 years
Secondary 2y Overall Survival rate 3.5 years
Secondary Overall Survival 3.5years
Secondary Progression Free Survival(PFS) 2.5years
Secondary QOL 2.5years
Secondary Biomarker(IMPACT assay Chips, whole blood, tumor tissue, Serum) vascular endothelial growth factor(VEGF)-A, VEGFR-2, VEGF-C, platelet derived growth factor(PDGF)-C, Soluble fms-like tyrosine kinase-1, VEGFR-3, Interleukin(IL)-8, Basic Fibroblast Growth Factor(FGFb), placental growth factor(PLGF), E-Selectin, intercellular adhesion molecule(ICAM)-1, neuropilin of Tumor tissue, single nucleotide polymorphism(SNP):VEGFR-1 and VEGF of whole blood DNA, angiotensin(ANG) and Apelin of serum. 2.5years
Secondary Safety(Collection of adverse events) 2.5years
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