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

NCT01989780 | Completed Phase 2 DMC

• 2 other identifiers: JBCRG-M04UMIN000012179
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to failure of strategy (TFS)

  2.5 years

Secondary Outcomes (6)

• 2y Overall Survival rate

  3.5 years

• Overall Survival

  3.5years

• Progression Free Survival(PFS)

  2.5years

• QOL

  2.5years

• Biomarker(IMPACT assay Chips, whole blood, tumor tissue, Serum)

  2.5years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

weekly paclitaxel + bevacizumab

Drug: Paclitaxel; Drug: Bevacizumab

Arm B

EXPERIMENTAL

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

Drug: Paclitaxel; Drug: Bevacizumab; Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Goserelin; Drug: leuprorelin

Interventions

Paclitaxel DRUG

Also known as: Taxol

Arm A; Arm B

Bevacizumab DRUG

Also known as: Avastin

Arm A; Arm B

Letrozole DRUG

Also known as: Femara

Arm B

Anastrozole DRUG

Also known as: Arimidex

Arm B

Exemestane DRUG

Also known as: Aromasin

Arm B

Fulvestrant DRUG

Also known as: Faslodex

Arm B

Goserelin DRUG

Also known as: Zoladex

Arm B

leuprorelin DRUG

Also known as: Leuplin

Arm B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Breast Cancer Research Group: lead
• Chugai Pharmaceutical: collaborator

Study Sites (1)

Japan Breast Cancer Research Group

Chuo-ku, Nihonbashi, Koami-cho, Tokyo, 1030016, Japan

Location

Related Publications (1)

• Saji S, Taira N, Kitada M, Takano T, Takada M, Ohtake T, Toyama T, Kikawa Y, Hasegawa Y, Fujisawa T, Kashiwaba M, Ishida T, Nakamura R, Yamamoto Y, Toh U, Iwata H, Masuda N, Morita S, Ohno S, Toi M. Switch maintenance endocrine therapy plus bevacizumab after bevacizumab plus paclitaxel in advanced or metastatic oestrogen receptor-positive, HER2-negative breast cancer (BOOSTER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2022 May;23(5):636-649. doi: 10.1016/S1470-2045(22)00196-6. Epub 2022 Apr 8.

  PMID: 35405087 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Bevacizumab; Letrozole; Anastrozole; exemestane; Fulvestrant; Goserelin; Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins

Study Officials

• Masakazu Toi, MD, PhD

  Kyoto University, Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

• Shigehira Saji, MD, PhD

  Fukushima Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 21, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 4, 2022

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)