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Breast NeoplasmsPhase 2NCT06539559

Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer

A Phase 2 study testing Eribulin and Bevacizumab in people with Breast Neoplasms and Neoplasm Metastasis, run by Wang Jiayu at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a prospective, multicenter, phase II randomized clinical trial. It is planned to enroll 60 patients with advanced HER2 negative breast cancer, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Eribulin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesChina
Study dates
1 Aug 2024to 1 Aug 2026
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old，and ≤75 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival period not less than 12 weeks.
  • At least 1 measurable lesion according to RECIST 1.1 standard.
  • previously treated with taxanes and/or anthracycline drugs in any stage of breast cancer.
  • Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated HER2 negative, including IHC- and IHC 1+/2+ with FISH negative.
Show all 21Show fewer
  • at least prior 1 line of chemotherapy in the advanced stage.
  • The organ function must meet the following requirements：
  • (1). Blood Routine
  • ANC≥1.5×109/L；
  • PLT≥90×109/L；
  • Hb≥90 g/L；
  • (2). Blood Biochemistry
  • TBIL≤1.5×ULN；
  • ALT and AST≤2×ULN；ALT和AST≤5×ULN for patients with liver metastasis；
  • BUN and Cr≤1.5×ULN and the Creatinine Clearance Rate ≥50 mL/min (Cockcroft-Gault formula calculated)；
  • (3). Echocardiogram
  • LVEF≥50%；
  • (4). electrocardiogram
  • The QT interval (QTcF) corrected by Fridericia method less than 450 ms for male and less than 470 ms for female.
  • 9. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.

Who cannot join

  • There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).
  • Symptomatic or uncontrolled brain or meningeal metastases.
  • Patients with only bone or skin metastasis as the assessable lesion.
  • Previously suffered from other malignant tumors.
  • Those who have used Eribulin during the advanced disease stage.
  • Individuals with a known history of allergies to the components of the interventions; History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases and a history of organ transplantation.
Show all 11Show fewer
  • Any heart disease or other conditions evaluated unsuitable by the researcher.
  • Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of reproductive age who are unwilling to take effective contraceptive measures throughout the trial period.
  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including severe bleeding tendency, history of surgery within 2 weeks, hypertension beyond drug control, serious diabetes, active infection, thyroid disease, etc.).
  • Having a clear history of neurological or mental disorders, including epilepsy or dementia.
  • According to the RECIST 1.1 criteria, researchers determined that patients who received the last anti-tumor regimen before enrollment did not experience disease progression.

Trial locations and contacts

3 sites in 1 country.

Yan Wang, doctor contact

+86-15600990767

wangyan07425@163.com

Hangcheng Xu, doctor contact

+86-19800353631

xuhangcheng15@126.com

China3 sites

  • Beijing Chaoyang District San Huan Cancer Hospital

    Beijing, Beijing Municipality, 100021

  • Cancer Hospital of HuanXing ChaoYang District

    Beijing, Beijing Municipality, 100021

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Efficacy, Adverse Events and Resistant Mechanism of Eribulin Combined With or Without Bevacizumab for Advanced HER2 Negative Breast Cancer Patients, an Open-label, Randomized, Multi-center PhaseⅡ Clinical Trial.

This study is a prospective, multicenter, phase II randomized clinical trial. It is planned to enroll 60 patients with advanced HER2 negative breast cancer, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The participants will receive either eribulin combined with bevacizumab or eribulin monotherapy. Every treatment cycle will last for 21 days, with weekly monitoring of blood routine, blood biochemistry and other indicators. Imaging examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 1.1 standard. The life quality questionnaire is arranged at baseline and every 3 months after enrollment, and the long-time survival will be followed every 3 months after treatment. The primary endpoint is progression-free survival (PFS), the secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). The investigators will also focus on the treatment-related adverse events (TRAE) and quality of life (QoL) assessment.

At the same time, this study also aims to explore the resistant mechanisms of anti-angiogenic drugs. The investigators plan to collect peripheral venous blood samples at 3 time points: baseline, during treatment, and end of treatment. All the dynamic samples will be used for transcriptome sequencing to obtain the gene sets. And based on the optimal therapeutic efficacy, all the participants will be divided into response group and non-response group. GO and KEGG enrichment analysis will be subsequently performed between different therapeutic efficacy groups to draw gene interaction networks, identify key action nodes and explain the mechanism of anti-angiogenic drug resistance.

Being tested
Eribulin, Bevacizumab
Keywords
breast cancer, HER2 negative, eribulin, bevacizumab, efficacy, resistant mechanism
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • EribulinDrug

    Also called Halaven

    Based on the results of STUDY301 and STUDY304, eribulin showed outstanding therapeutic effect and tolerable adverse events in patients with metastatic breast cancer

  • BevacizumabDrug

    Also called Avastin

    Study E2100, AVADO and RIBBON-1 found that in the first-line chemotherapy for advanced breast cancer, the addition of bevacizumab can significantly improve the efficacy of traditional chemotherapy drugs. Study RIBBON-2 and TANIA have confirmed the effectiveness of bevacizumab in the second and third line treatment of advanced HER2 negative breast cancer. Compared with chemotherapy alone, the addition of bevacizumab can prolong the PFS by 0.6 to 2.1 months.

Study groups in NCT06539559
Study groupRoleWhat they receive
eribulin+bevacizumabExperimentaleribulin 1.4 mg/m2 iv d1,8 + bevacizumab 7.5mg/kg ivgtt d1/q21d
Receives: Drug: Eribulin; Drug: Bevacizumab
eribulinActive comparatoreribulin 1.4 mg/m2 iv d1,8/q21d
Receives: Drug: Eribulin

What is being measured

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

  1. progression-free survival (PFS)

    PFS is defined as the time from randomization to the date of confirmed radiological progression or death from any cause.

    Measured: Radiological examinations will be conducted every two cycles: at the end of Cycle 2, 4, 6, 8......(each cycle is 21 days). The PFS will last until disease progression.

Secondary outcomes (3)

  1. overall survival (OS)

    OS is defined as the time from randomization to the date of death from any cause and censored at the date of final contact for patients who were still alive.

    Measured: The long-time survival will be followed every 3 months after the end of treatment.

  2. objective response rate (ORR)

    ORR is defined as the proportion of patients with best response of complete response (CR) and partial response (PR) according to RECIST 1.1 standard.

    Measured: Radiological examinations will be conducted every two cycles: at the end of Cycle 2, 4, 6, 8......(each cycle is 21 days). The efficacy will be evaluated according to RECIST 1.1 standard.

  3. clinical benefit rate (CBR)

    CBR is defined as the proportion of patients with best response of complete response (CR) , partial response (PR) and stable disease (SD) according to RECIST 1.1 standard.

    Measured: Radiological examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 1.1 standard.

Timeline

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

  1. First posted6 Aug 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

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
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06539559
Sponsor's protocol ID
CancerIHCAMS-Wjiayu
Status last verified
Aug 2024
First submitted
28 Jul 2024
Last updated
6 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Hardy-Bessard AC, Brocard F, Clatot F, Lortholary A, You B, Grenier J, Martin-Babau J, Lucas B, Meunier J, Ferrero JM, Savoye AM, Marti A, Despax R, Moullet I, Emile G. First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study. Breast. 2020 Dec;54:256-263. doi: 10.1016/j.breast.2020.09.011. Epub 2020 Sep 30.

    PubMed 33188992

  • Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, Cheng Y, Ouyang Q, Wang X, Chen Z, Hiraiwa M, Saito K, Funasaka S, Xu B. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. doi: 10.1016/j.ejca.2019.02.002. Epub 2019 Mar 29.

    PubMed 30928806

  • Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

    PubMed 25605862

  • Liu B, Liu L, Ran J, Xie N, Li J, Xiao H, Yang X, Tian C, Wu H, Lu J, Gao J, Hu X, Cao M, Shui Z, Hu ZY, Ouyang Q. A randomized trial of eribulin monotherapy versus eribulin plus anlotinib in patients with locally recurrent or metastatic breast cancer. ESMO Open. 2023 Jun;8(3):101563. doi: 10.1016/j.esmoop.2023.101563. Epub 2023 Jun 6.

    PubMed 37285718

  • von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.

    PubMed 25273342

  • Brufsky AM, Hurvitz S, Perez E, Swamy R, Valero V, O'Neill V, Rugo HS. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2011 Nov 10;29(32):4286-93. doi: 10.1200/JCO.2010.34.1255. Epub 2011 Oct 11.

    PubMed 21990397

  • Robert NJ, Dieras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, Perez EA, Yardley DA, Chan SY, Zhou X, Phan SC, O'Shaughnessy J. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011 Apr 1;29(10):1252-60. doi: 10.1200/JCO.2010.28.0982. Epub 2011 Mar 7.

    PubMed 21383283

  • De Angelis C, Bruzzese D, Bernardo A, Baldini E, Leo L, Fabi A, Gamucci T, De Placido P, Poggio F, Russo S, Forestieri V, Lauria R, De Santo I, Michelotti A, Del Mastro L, De Laurentiis M, Giuliano M, De Placido S, Arpino G. Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI). ESMO Open. 2021 Apr;6(2):100054. doi: 10.1016/j.esmoop.2021.100054. Epub 2021 Feb 16.

    PubMed 33601296

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eribulin and Bevacizumab in people with Breast Neoplasms and Neoplasm Metastasis, run by Wang Jiayu at 3 sites in China.

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 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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?

Results are not available in the source record.

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

Contact Yan Wang, doctor (+86-15600990767, wangyan07425@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (PFS) (time frame: Radiological examinations will be conducted every two cycles: at the end of Cycle 2, 4, 6, 8......(each cycle is 21 days). The PFS will last until disease progression.). 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 NCT06539559, which also lists 8 linked publications.

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 6 Aug 2024.

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