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The XENERA™-1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Post-menopausal Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

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ClinicalTrials.gov Identifier: NCT03659136
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective of the trial is to assess the anti-tumor activity of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in post menopausal patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Xentuzumab Drug: Placebo Drug: Everolimus Drug: Exemestane Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: XENERA™-1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Post-menopausal Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 14, 2020
Estimated Study Completion Date : January 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xentuzumab/everolimus/exemestane Drug: Xentuzumab
Intravenous infusion

Drug: Everolimus
Tablet

Drug: Exemestane
Tablet

Placebo Comparator: Placebo/everolimus/exemestane Drug: Placebo
Intravenous infusion

Drug: Everolimus
Tablet

Drug: Exemestane
Tablet




Primary Outcome Measures :
  1. Progression free survival (PFS) as assessed by central review [ Time Frame: Up to 24 months ]
    Defined as time from randomisation until disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) or death from any cause, whichever occurs earlier


Secondary Outcome Measures :
  1. Overall survival (OS) defined as the time from randomisation until death from any cause [ Time Frame: Up to 3 years ]
    Defined as the time from randomisation until death from any cause

  2. Disease control (DC) [ Time Frame: Up to 24 months ]
    Defined as a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-Progressive Disease (Non- CR/Non-PD). SD and Non-CR/Non PD must have a minimum duration of 24 weeks from randomisation. Best overall response is defined according to RECIST version 1.1 and will consider all tumour assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent

  3. Duration of DC is defined as the time from randomisation until the earliest of disease progression or death, among patients with DC [ Time Frame: Up to 24 months ]
    Defined as the time from randomisation until the earliest of disease progression or death, among patients with DC

  4. Objective response (OR) Defined as a best overall response of complete response (CR) or partial response (PR) [ Time Frame: Up to 24 months ]
    Defined as a best overall response of CR or PR. Best overall response is defined according to RECIST version 1.1 and will consider all tumour assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent

  5. Time to pain progression or intensification of pain palliation [ Time Frame: Up to 24 months ]
    Defined as the time from randomisation until the earliest of a clinically significant increase in pain (≥2-point increase from baseline in the Brief Pain Inventory- Short Form [BPI-SF] Item 3) without a decrease in analgesics use, or intensification in pain palliation (≥2-point increase in the 8-point Analgesic Quantification Algorithm [AQA]), or death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented histologically confirmed breast cancer with ERand/ or PgR-positive and HER2-negative status
  • Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
  • Archival tumour sample available at the time of informed consent and provided to the central laboratory around the time of randomisation. Patients must provide a formalin-fixed paraffin embedded (FFPE) tissue biopsy sample preferably taken at the time of presentation with recurrent or metastatic disease (provision of a biopsy sample taken from the bone is not acceptable).
  • Patients must satisfy the following criteria for prior therapy:

    • Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor and/or tamoxifen if post-menopausal, or tamoxifen if pre or peri-menopausal or
    • Progressed while on or within 1 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if post-menopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or peri-menopausal.
  • Patients must not have received more than one previous line of non-steroidal aromatase inhibitor treatment for advanced/metastatic disease. Prior treatment with one line of CDK4/6 inhibitors is allowed.
  • Prior treatment with fulvestrant if duration was at least 2 years in the adjuvant setting or at least 6 months in the metastatic setting is allowed.
  • Patients must be post-menopausal at time of signature of trial informed consent.
  • Patients must have

    • At least one measurable non-visceral lesion according to RECIST version 1.1 in either lymph nodes, soft tissue, skin and/or
    • At least one measurable non-visceral lesion according to RECIST version 1.1 as lytic or mixed (lytic + blastic) in bone and/or
    • At least one non-measurable lytic or mixed (lytic + blastic) bone lesion according to RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
  • Adequate organ function

Exclusion Criteria:

  • Previous treatment with agents targeting the IGF pathway, PI3K, AKT, or mTOR pathways
  • Prior treatment with exemestane (except adjuvant exemestane stopped >12 months prior to start of study treatment as long as the patient did not recur during or within 12 months after the end of adjuvant exemestane)
  • Evidence of visceral metastasis/es (i.e. liver, lung, peritoneal, pleural metastases, malignant pleural effusions, malignant peritoneal effusions)
  • History or evidence of metastatic disease to the brain
  • Leptomeningeal carcinomatosis
  • Any previous chemotherapy for HR+ HER2- metastatic breast cancer
  • Radiotherapy within 4 weeks prior to the start of study treatment
  • Use of concomitant systemic sex hormone therapy
  • History or presence of cardiovascular abnormalities
  • Known pre-existing interstitial lung disease
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659136


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Locations
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United States, Arizona
Ironwood Cancer and Research Centers Recruiting
Chandler, Arizona, United States, 85224
Contact: Mikhail Shtivelband    +001 (480) 821-2838    shtivelband@ironwoodcrc.com   
Cancer Treatment Centers of America at Western Regional Medical Center Recruiting
Goodyear, Arizona, United States, 85338
Contact: Cynthia Lynch    +001 (623) 207 3000    cynthia.lynch@ctca-hope.com   
United States, Florida
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33901
Contact: Lowell Hart    +001 (239) 940-6890    llhart@flcancer.com   
United States, Illinois
Advocate Medical Group Oncology Recruiting
Niles, Illinois, United States, 60714
Contact: Sigrun Hallmeyer    +001 (847) 268-8200    sigrun.hallmeyer@advocatehealth.com   
Cancer Treatment Centers of America Recruiting
Zion, Illinois, United States, 60099
Contact: Laura Farrington    +001 (847) 731-1777    laura.farrington@ctca-hope.com   
United States, Indiana
Investigative Clinical Research of Indiana, LLC Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Ruemu Birhiray    +001 (317) 297-2208    rbirhiraymd@investigativeicr.com   
United States, Missouri
HCA Midwest Division Recruiting
Kansas City, Missouri, United States, 64132
Contact: Stephanie Graff    +001 (816) 276 4700    Stephanie.graff@hcahealthcare.com   
United States, New York
Hematology Oncology Associates of Rockland Recruiting
Nyack, New York, United States, 10960
Contact: Sung Ho Lee    +001 (845) 480-7440    lees@MontefioreNyack.org   
United States, North Carolina
Oncology Specialists of Charlotte, PA Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Justin Favaro    +001 (704) 342 1900    favarojp77@gmail.com   
United States, Oklahoma
Southwestern Regional Medical Center Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Sagun Shrestha    +001 (918) 286 5000    Sagun.shrestha@ctca-hope.com   
United States, Pennsylvania
Cancer Treatment Centers of America at Eastern Regional Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Sramila Aithal    +001 (215) 537 7400    sramila.aithal@ctca-hope.com   
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Howard Burris    +001 (615) 329-7274    hburris@tnonc.com   
United States, Texas
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
Contact: Robyn Young    +001 (817) 759-7000    ryoung@txcc.com   
United States, Virginia
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Contact: Reed Mitchell    +001 (804) 287-3000    rbm@5mitch.net   
Australia, New South Wales
The Tweed Hospital Recruiting
Tweed Heads, New South Wales, Australia, 2485
Contact: Ehtesham Abdi    61755067478    ehtesham.abdi@health.nsw.gov.au   
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Bianca Devitt    61 3 9895 3281    bianca.devitt@monash.edu   
Peninsula Haematology & Oncology Recruiting
Frankston, Victoria, Australia, 3199
Contact: Vinod Ganju    61 3 9781 5244    vg@paso.com.au   
Belgium
Brussels - UNIV UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Christel Fontaine    +32 (0)2 477 64 15    christel.fontaine@uzbrussel.be   
Brussels - UNIV Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: François Duhoux    +32 (0)71    francois.duhoux@uclouvain.be   
Kortrijk - HOSP AZ Groeninge Kennedylaan Recruiting
Kortrijk, Belgium, 8500
Contact: Marleen Borms    +32 (0)56 63 39 00    marleen.borms@azgroeninge.be   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Patrick Neven    +32 (0)16 34 46 34    patrick.neven@uzleuven.be   
Canada, Quebec
McGill University Health Centre (MUHC) Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Nathaniel Bouganim    514 934-1934 x135800    nathaniel.bouganim@mail.mcgill.ca   
Canada
CHU de Quebec-Universite Laval Research Centre Recruiting
Quebec, Canada, G1S 4L8
Contact: Julie Lemieux    418-649-0252    julie.lemieux@crchudequebec.ulaval.ca   
France
CLI Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33000
Contact: Nadine Dohollou    +33 (0)5 56 43 73 54    n.dohollou@bordeauxnord.com   
HOP Victor Hugo Recruiting
Le Mans, France, 72000
Contact: Hugues Bourgeois    +33 (0)2 43 29 79 88    essaisbourgeois@i-l-c.fr   
INS Paoli-Calmettes Recruiting
Marseille, France, 13009
Contact: Anthony Goncalves    +33 (0)4 91 22 35 37    goncalvesa@ipc.unicancer.fr   
INS Curie Recruiting
Paris, France, 75248
Contact: Francesco Ricci    +33 (0)1 44 32 46 06    francesco.ricci@curie.fr   
HOP Européen G. Pompidou Recruiting
Paris, France, 75908
Contact: Jacques Medioni    +33 (0)1 56 09 27 81    jacques.medioni@aphp.fr   
HOP Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: Olivia Le Saux    +33 (0)4 78 86 43 24    olivia.le-saux@chu-lyon.fr   
Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Peter Fasching    09131 853-3451    Peter.fasching.studien@uk-erlangen.de   
Onkologische Schwerpunktpraxis Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Stefan Fuxius    +49 (6221) 714990    stefanfuxius@gmx.de   
Vincentius-Diakonissen-Kliniken gAG Recruiting
Karlsruhe, Germany, 76135
Contact: Oliver Tomé    +49 (721) 81089003    oliver.tome@vincentius-ka.de   
St. Elisabeth-Krankenhaus Recruiting
Köln, Germany, 50935
Contact: Claudia Schumacher    +49 (221) 46772301    claudia.schumacher@hohenlind.de   
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Andreas Hartkopf    +49 (7071) 2982236    Andreas.Hartkopf@med.uni-tuebingen.de   
Greece
University General Hospital of Heraklion Recruiting
Heraklion, Greece, 71110
Contact: Dimitrios Mavroudis    00302810392750    mavroudis@uoc.gr   
University Hospital of Larisa, Oncology Clinic Recruiting
Larisa, Greece, 41334
Contact: Athanasios Kotsakis    00302810392783    thankotsakis@hotmail.com   
Metropolitan Hospital, Oncology Clinic Recruiting
Neo Faliro, Athens, Greece, 18547
Contact: Helena Linardou    00302104809852    elinardou@otenet.gr   
Euromedica Kyanous Stavros General Hospital Recruiting
Thessaloniki, Greece, 54645
Contact: Konstantinos Papazisis    +302310895362    konstantinos.papazisis@gmail.com   
Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza Recruiting
Roma, Italy, 00189
Contact: Paolo Marchetti    +39 (06) 33775831    marchetti.paaolo@gmail.com   
Portugal
Hospital de Braga-Escala Braga Recruiting
Braga, Portugal, 4710-243
Contact: Catarina Portela    +351 253209000    portela.catarina@gmail.com   
Hospital Beatriz Ângelo Recruiting
Loures, Portugal, 2674-514
Contact: José Coelho       jlpassoscoelho@hbeatrizangelo.pt   
USLM, EPE - Hospital Pedro Hispano Recruiting
Matosinhos, Portugal, 4464-513
Contact: Matilde Salgado    +351 22 9391276    matilde.salgado@ulsm.min-saude.pt   
H. Santo António - Centro Hospitalar do Porto Recruiting
Porto, Portugal, 4099-001
Contact: Noémia Afonso    +351 22 207 7500    noemia.afonso@netcabo.pt   
Spain
Hospital Teresa Herrera Recruiting
A Coruña, Spain, 15006
Contact: Silvia Antolín Novoa    +34981178000 ext.292022    Silvia.Antolin.Novoa@sergas.es   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Patricia Gómez Pardo    +34932746085    pgomez@vhio.net   
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: María Jesús Vidal Losada    +34932275402    mjvidal@clinic.cat   
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Sara López-Tarruella    +34914269070    slopeztarruella@gmail.com   
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Noelia Martínez Jañez    +34913368263    mjnoelia@hotmail.com   
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: José Angel García Sáenz    +34913303000 ext.7768    jagsaenz@yahoo.com   
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain, 29010
Contact: Tamara Díaz Redondo    +34951032508    tdredondo@gmail.com   
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Alejandro Pérez Fidalgo    +34961973500    japfidalgo@msn.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03659136     History of Changes
Other Study ID Numbers: 1280-0022
2017-003131-11 ( EudraCT Number )
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Everolimus
Sirolimus
Exemestane
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists