Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients
NCT ID: NCT02175446
Last Updated: 2016-06-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
61 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-09-30
Study Completion Date
2017-12-31
Brief Summary
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In the second-line treatment setting for MBC, many agents, including antitubulin drugs (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated activity, but no agent is clearly superior. Although some combinations of cytotoxic agents provide a small progression-free survival advantage, none has demonstrated an OS advantage, and toxicity is generally greater than for single agents. At present, there is no standard for this treatment setting. New treatments that could delay disease progression without systemic toxicity would represent a significant advancement.
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Detailed Description
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Metastatic breast cancer (MBC) is incurable, and the majority of patients succumb to their disease within 2 years of diagnosis.
Patients with MBC usually receive treatment with endocrine or cytotoxic chemotherapeutic agents, and treatment decisions are generally guided by the hormone receptor and Human Epidermal Growth Factor Receptor 2-Negative status of the disease, the number and location of metastases, and prior treatment history in both adjuvant and metastatic settings. In first- and second-line treatment settings of Metastatic Breast Cancer, numerous cytotoxic chemotherapy agents have demonstrated activity, including anti-tubulin drugs (Taxanes, Vinorelbine), Anthracyclines, and anti-metabolites (Capecitabine, Gemcitabine). However, no single agent has demonstrated a clear survival advantage over another, and use of sequential single-agent therapies is the most frequent approach. The choice of chemotherapy agent(s) is often determined by a number of factors, including history of prior therapy, treatment-free interval, and patient preference. Thus, no single standard treatment exists for patients with advanced disease. Patients who progress during or after their first treatment for Metastatic Brest Cancer typically have a short progression-free interval of 4-6 months and survive for 8-12 months. New treatment modalities are needed to improve clinical outcome and maintain the quality of life for these patients.
Patients with MBC usually receive treatment with endocrine or cytotoxic chemotherapeutic agents, and treatment decisions are generally guided by the hormone receptor and Human Epidermal Growth Factor Receptor 2-Negative status of the disease, the number and location of metastases, and prior treatment history in both adjuvant and metastatic settings. In first- and second-line treatment settings of Metastatic Breast Cancer, numerous cytotoxic chemotherapy agents have demonstrated activity, including anti-tubulin drugs (Taxanes, Vinorelbine), Anthracyclines, and anti-metabolites (Capecitabine, Gemcitabine). However, no single agent has demonstrated a clear survival advantage over another, and use of sequential single-agent therapies is the most frequent approach. The choice of chemotherapy agent(s) is often determined by a number of factors, including history of prior therapy, treatment-free interval, and patient preference. Thus, no single standard treatment exists for patients with advanced disease. Patients who progress during or after their first treatment for Metastatic Brest Cancer typically have a short progression-free interval of 4-6 months and survive for 8-12 months. New treatment modalities are needed to improve clinical outcome and maintain the quality of life for these patients.
Conditions
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Metastatic Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Experimental1
Bevacizumab and eribulin
In this study all patients will receive:
* Eribulin 1.23 mg/m2 on days 1, 8 every 3 weeks intravenously
* Bevacizumab 15 mg/kg every 3 weeks intravenously or Bevacizumab 10 mg/kg every 2 weeks intravenously
Group Type
EXPERIMENTAL
Bevacizumab and eribulin
Intervention Type
DRUG
In this study, Bevacizumab and Eribulin are considered to be the "investigational study drugs". Bevacizumab is provided as 25 mg/ml concentrate for infusion. Vials contain 100 mg of Bevacizumab in 4 ml and/or 400 mg in 16 ml. Eribulin is provided as vials containing 1 mg/2 mL Eribulin as a 500 µg/mL solution in ethanol/water
Interventions
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Bevacizumab and eribulin
In this study, Bevacizumab and Eribulin are considered to be the "investigational study drugs". Bevacizumab is provided as 25 mg/ml concentrate for infusion. Vials contain 100 mg of Bevacizumab in 4 ml and/or 400 mg in 16 ml. Eribulin is provided as vials containing 1 mg/2 mL Eribulin as a 500 µg/mL solution in ethanol/water
Intervention Type
DRUG
Other Intervention Names
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Halaven
Avastin
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness to comply with the study requirements.
* Female patients ≥18 years of age.
* Histologically confirmed Human Epidermal Growth Factor Receptor 2-Negative adenocarcinoma of the breast with documented progression of disease per investigator assessment following or during first-line treatment with Bevacizumab in combination with Paclitaxel for MBC; patients can have measurable or non-measurable disease. A minimum of 4 cycles of Bevacizumab 15 mg/kg or 6 cycles 10 mg/kg received in the first-line setting.
* Patients must have received Bevacizumab in combination with Paclitaxel as first line treatment. As part of their first line maintenance treatment, patients may have received:
* Bevacizumab monotherapy
* Bevacizumab in combination with endocrine treatment
* Nothing (for a period ≤ 6 weeks from the last Bevacizumab treatment)
* ECOG performance status (PS) of 0-2.
* At least 28 days since prior radiation therapy or surgery and recovery from treatment.
* Patients must have measurable disease which must be evaluable per RECIST v1.1.
* Estimated life expectancy of ≥12 weeks.
* Female patients ≥18 years of age.
* Histologically confirmed Human Epidermal Growth Factor Receptor 2-Negative adenocarcinoma of the breast with documented progression of disease per investigator assessment following or during first-line treatment with Bevacizumab in combination with Paclitaxel for MBC; patients can have measurable or non-measurable disease. A minimum of 4 cycles of Bevacizumab 15 mg/kg or 6 cycles 10 mg/kg received in the first-line setting.
* Patients must have received Bevacizumab in combination with Paclitaxel as first line treatment. As part of their first line maintenance treatment, patients may have received:
* Bevacizumab monotherapy
* Bevacizumab in combination with endocrine treatment
* Nothing (for a period ≤ 6 weeks from the last Bevacizumab treatment)
* ECOG performance status (PS) of 0-2.
* At least 28 days since prior radiation therapy or surgery and recovery from treatment.
* Patients must have measurable disease which must be evaluable per RECIST v1.1.
* Estimated life expectancy of ≥12 weeks.
Exclusion Criteria
Disease-specific exclusions
* Patients who have received anti-angiogenic therapy \[e.g. tyrosine kinase inhibitors (TKIs) or anti-vascular endothelial growth factors (anti-VEGFs)\] other than Bevacizumab for the first-line treatment of MBC.
* Patients who have exclusively received endocrine treatment in combination with Bevacizumab until the first progression.
* Positive or unknown Human Epidermal Growth Factor Receptor 2/neu status or for whom determination of Human Epidermal Growth Factor Receptor 2 status is not possible. In general, Human Epidermal Growth Factor Receptor 2 positive status will be identified by a FISH assay as evaluated at the institution, or, if FISH is unavailable, a 2+ or 3+ immunohistochemistry result (but method of identification may vary by region or institution).
* Current, recent (within 4 weeks or 2 half-lives, whichever is greater, before day 1) or planned participation in an experimental drug study - other than a Bevacizumab breast cancer study.
* Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix or breast within the last 5 years.
* Any laboratory values at baseline as described in the protocol;
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
* Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
* Patients who are treated with any medicinal product that contraindicates the use of any of the study drugs, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
Bevacizumab-specific exclusions: (see protocol)
Eribulin-specific exclusions: (see protocol)
* Patients who have received anti-angiogenic therapy \[e.g. tyrosine kinase inhibitors (TKIs) or anti-vascular endothelial growth factors (anti-VEGFs)\] other than Bevacizumab for the first-line treatment of MBC.
* Patients who have exclusively received endocrine treatment in combination with Bevacizumab until the first progression.
* Positive or unknown Human Epidermal Growth Factor Receptor 2/neu status or for whom determination of Human Epidermal Growth Factor Receptor 2 status is not possible. In general, Human Epidermal Growth Factor Receptor 2 positive status will be identified by a FISH assay as evaluated at the institution, or, if FISH is unavailable, a 2+ or 3+ immunohistochemistry result (but method of identification may vary by region or institution).
* Current, recent (within 4 weeks or 2 half-lives, whichever is greater, before day 1) or planned participation in an experimental drug study - other than a Bevacizumab breast cancer study.
* Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix or breast within the last 5 years.
* Any laboratory values at baseline as described in the protocol;
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
* Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
* Patients who are treated with any medicinal product that contraindicates the use of any of the study drugs, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
Bevacizumab-specific exclusions: (see protocol)
Eribulin-specific exclusions: (see protocol)
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Clinical Research Technology S.r.l.
INDUSTRY
Sponsor Role
collaborator
Consorzio Oncotech
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Grazia Arpino, MD
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
Locations
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Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, , Italy
Site Status
RECRUITING
Ospedale 'F. Spaziani'
Frosinone, , Italy
Site Status
RECRUITING
I.R.C.C.S. A.O.U. San Martino - I.S.T.
Genova, , Italy
Site Status
RECRUITING
Ospedale Unico Versilia
Lido di Camaiore, , Italy
Site Status
RECRUITING
Ospedale San Luca Istituto Tumori Toscano
Lucca, , Italy
Site Status
RECRUITING
Ospedale civile di Macerata
Macerata, , Italy
Site Status
RECRUITING
A.O.R.N. "A. Cardarelli"
Naples, , Italy
Site Status
RECRUITING
Università degli Studi di Napoli "Federico II"
Naples, , Italy
Site Status
RECRUITING
Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale"
Napoli, , Italy
Site Status
RECRUITING
AORN - Ospedali dei Colli Monaldi-Cotugno - C.T.O.
Napoli, , Italy
Site Status
RECRUITING
I.R.C.C.S. Fondazione Salvatore Maugeri
Pavia, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
Pisa, , Italy
Site Status
RECRUITING
Presidio Ospedaliero Felice Lotti Pontedera
Pontedera, , Italy
Site Status
RECRUITING
Istituto Regina Elena per lo studio e la cura dei tumori
Roma, , Italy
Site Status
RECRUITING
Azienda Ospedaleira Universitaria San Giovanni di Dio e Ruggi d'aragona
Salerno, , Italy
Site Status
RECRUITING
Ospedale 'SS. Trinità'
Sora, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Universitaria Santa Maria della Misericordia di Udine
Udine, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Clinical Research Technology
Role: CONTACT
0039089301545
Facility Contacts
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Raffaella Ruocco, MD
Role: primary
References
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Baffert F, Le T, Sennino B, Thurston G, Kuo CJ, Hu-Lowe D, McDonald DM. Cellular changes in normal blood capillaries undergoing regression after inhibition of VEGF signaling. Am J Physiol Heart Circ Physiol. 2006 Feb;290(2):H547-59. doi: 10.1152/ajpheart.00616.2005. Epub 2005 Sep 19.
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Mancuso MR, Davis R, Norberg SM, O'Brien S, Sennino B, Nakahara T, Yao VJ, Inai T, Brooks P, Freimark B, Shalinsky DR, Hu-Lowe DD, McDonald DM. Rapid vascular regrowth in tumors after reversal of VEGF inhibition. J Clin Invest. 2006 Oct;116(10):2610-21. doi: 10.1172/JCI24612.
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RESULT
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Gray R, Bhattacharya S, Bowden C, Miller K, Comis RL. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2009 Oct 20;27(30):4966-72. doi: 10.1200/JCO.2008.21.6630. Epub 2009 Aug 31.
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RESULT
Miles DW, Chan A, Dirix LY, Cortes J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3239-47. doi: 10.1200/JCO.2008.21.6457. Epub 2010 May 24.
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RESULT
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Grothey A, Sugrue MM, Purdie DM, Dong W, Sargent D, Hedrick E, Kozloff M. Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE). J Clin Oncol. 2008 Nov 20;26(33):5326-34. doi: 10.1200/JCO.2008.16.3212. Epub 2008 Oct 14.
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Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, von Moos R, Vieitez JM, Bouche O, Borg C, Steffens CC, Alonso-Orduna V, Schlichting C, Reyes-Rivera I, Bendahmane B, Andre T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.
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Cigler T, Vahdat LT. Eribulin mesylate for the treatment of breast cancer. Expert Opin Pharmacother. 2010 Jun;11(9):1587-93. doi: 10.1517/14656566.2010.486790.
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RESULT
Kuznetsov G, Towle MJ, Cheng H, Kawamura T, TenDyke K, Liu D, Kishi Y, Yu MJ, Littlefield BA. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res. 2004 Aug 15;64(16):5760-6. doi: 10.1158/0008-5472.CAN-04-1169.
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RESULT
Cortes J, Vahdat L, Blum JL, Twelves C, Campone M, Roche H, Bachelot T, Awada A, Paridaens R, Goncalves A, Shuster DE, Wanders J, Fang F, Gurnani R, Richmond E, Cole PE, Ashworth S, Allison MA. Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2010 Sep 1;28(25):3922-8. doi: 10.1200/JCO.2009.25.8467. Epub 2010 Aug 2.
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RESULT
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RESULT
Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.
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RESULT
von Minckwitz G, du Bois A, Schmidt M, Maass N, Cufer T, de Jongh FE, Maartense E, Zielinski C, Kaufmann M, Bauer W, Baumann KH, Clemens MR, Duerr R, Uleer C, Andersson M, Stein RC, Nekljudova V, Loibl S. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a german breast group 26/breast international group 03-05 study. J Clin Oncol. 2009 Apr 20;27(12):1999-2006. doi: 10.1200/JCO.2008.19.6618. Epub 2009 Mar 16.
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RESULT
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Reference Type
RESULT
Other Identifiers
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2013-003194-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GIM11-BERGI
Identifier Type: -
Identifier Source: org_study_id
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A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
NCT01268150
COMPLETED
PHASE2
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
NCT02675231
COMPLETED
PHASE2
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients
NCT01795586
COMPLETED
PHASE1
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
NCT05945368
UNKNOWN
PHASE2