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

• Status: Active, not recruiting
• Trial end date: 2022-03-22
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Everolimus; Exemestane; Sirolimus

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 mg/dL) 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