The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
NCT ID: NCT03659136
Last Updated: 2025-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2018-11-28
2022-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Xentuzumab/everolimus/exemestane
Xentuzumab
Intravenous infusion
Everolimus
Tablet
Exemestane
Tablet
Placebo/everolimus/exemestane
Placebo
Intravenous infusion
Everolimus
Tablet
Exemestane
Tablet
Interventions
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Xentuzumab
Intravenous infusion
Placebo
Intravenous infusion
Everolimus
Tablet
Exemestane
Tablet
Eligibility Criteria
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Inclusion Criteria
* 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:
* Disease progression during treatment or within 12 months of completion of endocrine adjuvant therapy or
* Disease progression while on or within 1 month after the end of prior endocrine therapy for advanced/metastatic breast cancer (Note: the endocrine therapy does not have to be the treatment immediately prior to trial entry).
* 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, mixed lytic + blastic, or blastic) bone lesion according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
* Fasting glucose \<8.9 mmol/L (\<160 mg/dL) and HbA1c \<8.0%
* Adequate organ function
Exclusion Criteria
* 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) at screening. NOTE: Patients with a past history of visceral metastases are eligible if visceral metastases have completely resolved at least 3 months
* History or evidence of metastatic disease to the brain
* Leptomeningeal carcinomatosis
* More than 1 prior line of 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
18 Years
FEMALE
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Cancer Treatment Centers of America at Western Regional Medical Center
Goodyear, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
University of California San Francisco
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University Cancer and Blood Center
Athens, Georgia, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
HCA MidAmerica Division, Inc.
Kansas City, Missouri, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Peninsula Haematology & Oncology
Frankston, Victoria, Australia
Brussels - UNIV Saint-Luc
Brussels, , Belgium
Brussels - UNIV UZ Brussel
Jette, , Belgium
Kortrijk - HOSP AZ Groeninge Kennedylaan
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Quebec-Universite Laval Research Centre
Québec, , Canada
INS Sainte Catherine
Avignon, , France
HOP Victor Hugo
Le Mans, , France
INS Paoli-Calmettes
Marseille, , France
INS Curie
Paris, , France
HOP Européen G. Pompidou
Paris, , France
HOP Lyon Sud
Pierre-Bénite, , France
INS Claudius Regaud IUCT-Oncopole
Toulouse, , France
Universitätsklinikum Erlangen
Erlangen, , Germany
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, , Germany
General Hospital of Athens "Alexandra"
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
University Hospital of Larisa, Oncology Clinic
Larissa, , Greece
Metropolitan Hospital, Oncology Clinic
Neo Faliro, Athens, , Greece
Euromedica Kyanous Stavros General Hospital
Thessaloniki, , Greece
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli, , Italy
Iov, Irccs
Padua, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
Fundação Champalimaud,
Lisbon, , Portugal
Hospital Beatriz Ângelo
Loures, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Hospital Teresa Herrera
A Coruña, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Clínica Quirón de Valencia
Valencia, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
St Bartholomew's Hospital
London, , United Kingdom
Countries
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References
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Schmid P, Cortes J, Joaquim A, Janez NM, Morales S, Diaz-Redondo T, Blau S, Neven P, Lemieux J, Garcia-Saenz JA, Hart L, Biyukov T, Baktash N, Massey D, Burris HA 3rd, Rugo HS. XENERA-1: a randomised double-blind Phase II trial of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in patients with hormone receptor-positive/HER2-negative metastatic breast cancer and non-visceral disease. Breast Cancer Res. 2023 Jun 12;25(1):67. doi: 10.1186/s13058-023-01649-w.
Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2017-003131-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1280-0022
Identifier Type: -
Identifier Source: org_study_id
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