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Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer (BOOSTER)

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ClinicalTrials.gov Identifier: NCT01989780
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : August 4, 2022
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Japan Breast Cancer Research Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Paclitaxel Drug: Bevacizumab Drug: Letrozole Drug: Anastrozole Drug: Exemestane Drug: Fulvestrant Drug: Goserelin Drug: leuprorelin Phase 2

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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-
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
weekly paclitaxel + bevacizumab
 Drug: Paclitaxel
Other Name: Taxol

Drug: Bevacizumab
Other Name: Avastin
Experimental: Arm B

endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy

(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)

 Drug: Paclitaxel
Other Name: Taxol

Drug: Bevacizumab
Other Name: Avastin

Drug: Letrozole
Other Name: Femara

Drug: Anastrozole
Other Name: Arimidex

Drug: Exemestane
Other Name: Aromasin

Drug: Fulvestrant
Other Name: Faslodex

Drug: Goserelin
Other Name: Zoladex

Drug: leuprorelin
Other Name: Leuplin


Outcome Measures
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Primary Outcome Measures :
  1. Time to failure of strategy (TFS) [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. 2y Overall Survival rate [ Time Frame: 3.5 years ]
  2. Overall Survival [ Time Frame: 3.5years ]
  3. Progression Free Survival(PFS) [ Time Frame: 2.5years ]
  4. QOL [ Time Frame: 2.5years ]
  5. Biomarker(IMPACT assay Chips, whole blood, tumor tissue, Serum) [ Time Frame: 2.5years ]
    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.

  6. Safety(Collection of adverse events) [ Time Frame: 2.5years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989780


Locations
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Japan
Japan Breast Cancer Research Group
Chuo-ku, Nihonbashi, Koami-cho, Tokyo, Japan, 1030016
Sponsors and Collaborators
Japan Breast Cancer Research Group
Chugai Pharmaceutical
Investigators
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Principal Investigator: Masakazu Toi, MD, PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Shigehira Saji, MD, PhD Fukushima Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Japan Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT01989780    
Other Study ID Numbers: JBCRG-M04
UMIN000012179 ( Registry Identifier: UMIN )
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidetified patient data will be made available upon reasonable request.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Letrozole
Fulvestrant
Anastrozole
Exemestane
Goserelin
Leuprolide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists