Trial | NCT01989780  Report issue

Title

Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer
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-

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    160
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.
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).
Study Started
Jan 31
2014
Primary Completion
Jun 30
2018
Study Completion
Jun 30
2019
Last Update
Aug 04
2022

Drug Paclitaxel

  • Other names: Taxol

Drug Bevacizumab

  • Other names: Avastin

Drug Letrozole

  • Other names: Femara

Drug Anastrozole

  • Other names: Arimidex

Drug Exemestane

  • Other names: Aromasin

Drug Fulvestrant

  • Other names: Faslodex

Drug Goserelin

  • Other names: Zoladex

Drug leuprorelin

  • Other names: Leuplin

Arm A Active Comparator

weekly paclitaxel + bevacizumab

Arm B Experimental

endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy (*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)

Criteria 

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the breast
Female aged 20-75 years old at getting informed consent
HER2 negative disease (IHC 0/1+ or 2+ with FISH negative)
Documented estrogen receptor (ER) positive (>=1% by IHC)
Inoperative locally advanced or metastatic breast cancer at enrolment
Performance status (ECOG): 0-1 at enrolment
Life expectancy of at least 3 months from enrolment
No prior systemic therapy for recurrent breast cancer (excluding hormone therapy)
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
Patients with measurable lesion regarding with Response Evaluation Criteria in Solid Tumors(RECIST) criteria or who have evaluable lesion
Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT
No influence on protocol treatment is considered in case prior therapy or examination.

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+
Written informed consent signed by patients before completing any treatment related procedure

Exclusion Criteria:

Prior therapy with bevacizumab
Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV.
Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period.
Known hypersensitivity to bevacizumab or paclitaxel
History of hemoptysis (>= 2.5mL of bright red blood per episord).
Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride
Patients with CNS metastases (except for not symptomatic)
Persistent Grade >= 2 sensory neuropathy at enrollment
Grade 3 >= hypertension (>= 2 use of antihypertensive drug)
Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment.
Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment.
History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment
Cases that the investigator judged as inappropriate as the subject of this clinical study
No Results Posted