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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

Trial Status: Active

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 patients with HR+ / HER2- advanced or metastatic breast cancer and non-visceral disease.

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.
  • 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


San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222


New Haven
Yale University


University of Minnesota / Masonic Cancer Center
Status: ACTIVE
Contact: Heather Beckwith
Phone: 612-625-4918

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Boehringer Ingelheim Pharmaceuticals Inc

  • Primary ID 1280-0022
  • Secondary IDs NCI-2019-04526, 2017-003131-11
  • ID NCT03659136