JBCRG-M04 (BOOSTER)

JRCT ID: jRCTs021180026

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hormone receptor positive, HER2 negative advanced or recurrence (metastatic) breast cancer
• Date of first enrollment: 28/01/2014
• Target sample size: 160
• Study type: Interventional

Intervention(s)

Arm A) weekly paclitaxel + bevacizumab
Arm B) weekly paclitaxel + bevacizumab followed by hormone therapy + bevacizumab then back to induction therapy

Outcome(s)

• Primary Outcome: Time to failure of strategy (TFS)
• Secondary Outcome: 2y Overall Survival rate, Overall Survival, Progression Free Survival: PFS, QOL, Biomarker, Safety, Correlation between efficacy and adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include 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 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 WBC count >= 3000 /mm3
- Platelets >=10 x 10000 /mm3
- Hb >= 9 g/dL
- Total bilirubin <= 1.5 mg/dL(except for constitutional jaundice)
- AST and ALT <= 100IU/L (<=200IU/L if liver metastasis)
- Serum creatinine <= 1.5 mg/dL
-Urine dipstick for proteinuria <= 1+
14. Written informed consent signed by patients before conducting any treatment related procedure

Exclude 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 with venous 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

Related Information

• Primary Sponsor: Saji Shigehira
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000012179 / NCT01989780