Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients

NCT02175446 | Unknown Phase 2 DMC

• 2 other identifiers: GIM11-BERGI2013-003194-10
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Metastatic Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Keywords

Breast cancer; HER2Negative; Second line treatment; HER2-; MBC; Metastatic; Metastatic breast cancer; bevacizumab; eribulin; Human Epidermal Growth Factor Receptor 2-Negative

Outcome Measures

Primary Outcomes (1)

• Overall Response rate

  ORR will be evaluated for those patients who have a response to second-line treatment as defined per RECIST version 1.1 in patients with measurable disease according to RECIST version 1.1. ORR will be based on the best overall response (BOR) as defined by RECIST Guidelines v. 1.1.

  Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 30 months

Secondary Outcomes (6)

• Progression free survival

  Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 30 months

• Overall Survival

  Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 30 months

• Clinical Benefit Rate

  Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 30 months

• Duration of response

  Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 30 months

• Safety

  Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first, assessed up to 30 months

Study Arms (1)

Experimental1

EXPERIMENTAL

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

Drug: Bevacizumab and eribulin

Interventions

Bevacizumab and eribulin 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

Also known as: Halaven, Avastin

Experimental1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorzio Oncotech: lead
• Clinical Research Technology S.r.l.: collaborator

Study Sites (17)

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, 26100, Italy

RECRUITING

Ospedale 'F. Spaziani'

Frosinone, 03100, Italy

RECRUITING

I.R.C.C.S. A.O.U. San Martino - I.S.T.

Genova, 16132, Italy

RECRUITING

Ospedale Unico Versilia

Lido di Camaiore, 55041, Italy

RECRUITING

Ospedale San Luca Istituto Tumori Toscano

Lucca, Italy

RECRUITING

Ospedale civile di Macerata

Macerata, 62100, Italy

RECRUITING

A.O.R.N. "A. Cardarelli"

Naples, 80131, Italy

RECRUITING

Università degli Studi di Napoli "Federico II"

Naples, 80131, Italy

RECRUITING

Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale"

Napoli, 80131, Italy

RECRUITING

AORN - Ospedali dei Colli Monaldi-Cotugno - C.T.O.

Napoli, 83131, Italy

RECRUITING

I.R.C.C.S. Fondazione Salvatore Maugeri

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara

Pisa, 956126, Italy

RECRUITING

Presidio Ospedaliero Felice Lotti Pontedera

Pontedera, 56025, Italy

RECRUITING

Istituto Regina Elena per lo studio e la cura dei tumori

Roma, 00144, Italy

RECRUITING

Azienda Ospedaleira Universitaria San Giovanni di Dio e Ruggi d'aragona

Salerno, 84131, Italy

RECRUITING

Ospedale 'SS. Trinità'

Sora, 03039, Italy

RECRUITING

Azienda Ospedaliera Universitaria Santa Maria della Misericordia di Udine

Udine, 33100, Italy

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Grazia Arpino, MD

  Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Technology

CONTACT

0039089301545

Study Design

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

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (17)