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
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.
- 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
- 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
Locations & Contacts
Contact: Helen Diller Family Comprehensive Cancer Center
Contact: Heather Beckwith
Trial Phase & Type
Boehringer Ingelheim Pharmaceuticals Inc
Secondary IDs NCI-2019-04526, 2017-003131-11
Clinicaltrials.gov ID NCT03659136