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Metastatic Breast CancerPhase 2BOOSTERNCT01989780

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

A Phase 2 study testing Paclitaxel, Bevacizumab and Letrozole in people with Metastatic Breast Cancer, run by Japan Breast Cancer Research Group at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Paclitaxel, Bevacizumab and Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteJapan
Study dates
Jan 2014to Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Japan Breast Cancer Research Group

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

Other trials in Japan

About this study

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-

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.

Read the 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).

Being tested
Paclitaxel, Bevacizumab, Letrozole, Anastrozole, Exemestane
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

  • BevacizumabDrug

    Also called Avastin

  • LetrozoleDrug

    Also called Femara

  • AnastrozoleDrug

    Also called Arimidex

  • ExemestaneDrug

    Also called Aromasin

  • FulvestrantDrug

    Also called Faslodex

  • GoserelinDrug

    Also called Zoladex

  • leuprorelinDrug

    Also called Leuplin

Study groups in NCT01989780
Study groupRoleWhat they receive
Arm AActive comparatorweekly paclitaxel + bevacizumab
Receives: Drug: Paclitaxel; Drug: Bevacizumab
Arm BExperimentalendocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy (*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
Receives: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Goserelin; Drug: leuprorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to failure of strategy (TFS)

    Measured: 2.5 years

Secondary outcomes (6)

  1. 2y Overall Survival rate

    Measured: 3.5 years

  2. Overall Survival

    Measured: 3.5years

  3. Progression Free Survival(PFS)

    Measured: 2.5years

  4. QOL

    Measured: 2.5years

  5. 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.

    Measured: 2.5years

  6. Safety(Collection of adverse events)

    Measured: 2.5years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2018
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989780
Sponsor's protocol ID
JBCRG-M04
Other IDs
UMIN000012179
Acronym
BOOSTER
Status last verified
Jul 2019
First submitted
4 Nov 2013
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Deidetified patient data will be made available upon reasonable request.

Publications

  • 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.

    PubMed 35405087

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Bevacizumab and Letrozole in people with Metastatic Breast Cancer, run by Japan Breast Cancer Research Group at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to failure of strategy (TFS) (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01989780, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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