Breast Cancer Clinical Trial

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

Summary

The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

View Eligibility Criteria

Eligibility 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:

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 mgdL) and HbA1c <8.0%
Adequate organ function

Exclusion Criteria:

Previous treatment with agents targeting the IGF pathway, 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) 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
Further exclusion criteria apply

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

103

Study ID:

NCT03659136

Recruitment Status:

Completed

Sponsor:

Boehringer Ingelheim

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There are 53 Locations for this study

See Locations Near You

Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States
Cancer Treatment Centers of America at Western Regional Medical Center
Goodyear Arizona, 85338, United States
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
University of California San Francisco
San Francisco California, 94158, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
University Cancer and Blood Center
Athens Georgia, 30607, United States
Hematology Oncology of Indiana
Indianapolis Indiana, 46260, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
HCA MidAmerica Division, Inc.
Kansas City Missouri, 64132, United States
Hematology Oncology Associates of Rockland
Nyack New York, 10960, United States
Southwestern Regional Medical Center
Tulsa Oklahoma, 74133, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Utah Cancer Specialists Cancer Center
Salt Lake City Utah, 84106, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
The Tweed Hospital
Tweed Heads New South Wales, 2485, Australia
Peninsula Haematology & Oncology
Frankston Victoria, 3199, Australia
Brussels - UNIV Saint-Luc
Bruxelles , 1200, Belgium
Brussels - UNIV UZ Brussel
Jette , 1090, Belgium
Kortrijk - HOSP AZ Groeninge Kennedylaan
Kortrijk , 8500, Belgium
UZ Leuven
Leuven , 3000, Belgium
CHU de Quebec-Universite Laval Research Centre
Quebec , G1S 4, Canada
INS Sainte Catherine
Avignon , 84000, France
HOP Victor Hugo
Le Mans , 72000, France
INS Paoli-Calmettes
Marseille , 13009, France
INS Curie
Paris , 75248, France
HOP Européen G. Pompidou
Paris , 75908, France
HOP Lyon Sud
Pierre Benite , 69495, France
INS Universitaire du Cancer
Toulouse , 31059, France
Universitätsklinikum Erlangen
Erlangen , 91054, Germany
Vincentius-Diakonissen-Kliniken gAG
Karlsruhe , 76135, Germany
General Hospital of Athens "Alexandra"
Athens , 11528, Greece
University General Hospital of Heraklion
Heraklion , 71110, Greece
University Hospital of Larisa, Oncology Clinic
Larisa , 41334, Greece
Metropolitan Hospital, Oncology Clinic
Neo Faliro, Athens , 18547, Greece
Euromedica Kyanous Stavros General Hospital
Thessaloniki , 54645, Greece
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli , 80131, Italy
Iov, Irccs
Padova , 35128, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma , 00189, Italy
Fundação Champalimaud,
Lisboa , 1400-, Portugal
Hospital Beatriz Ângelo
Loures , 2674-, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia , 4434-, Portugal
Hospital Teresa Herrera
A Coruña , 15006, Spain
Hospital Clínic de Barcelona
Barcelona , 08036, Spain
Hospital Arnau de Vilanova
Lleida , 25198, Spain
Hospital General Universitario Gregorio Marañón
Madrid , 28007, Spain
Hospital Ramón y Cajal
Madrid , 28034, Spain
Hospital Clínico San Carlos
Madrid , 28040, Spain
Hospital Regional Universitario de Málaga
Málaga , 29010, Spain
Instituto Valenciano de Oncología
Valencia , 46009, Spain
Clínica Quirón de Valencia
Valencia , 46010, Spain
Hospital Clínico de Valencia
Valencia , 46010, Spain
St Bartholomew's Hospital
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

103

Study ID:

NCT03659136

Recruitment Status:

Completed

Sponsor:


Boehringer Ingelheim

How clear is this clinincal trial information?

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