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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT03659136

Run by

Boehringer Ingelheim

People needed

103

Starts

2018-11-28

Expected to finish

2022-05-11

Last updated by the study team

2025-02-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 mg/dL) and HbA1c <8.0%
• Adequate organ function

You may not qualify if…

• 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

Where it is running

• 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
• Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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