Description:
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.
Title
- Brief Title: 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
- Official Title: XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
Clinical Trial IDs
- ORG STUDY ID:
1280-0022
- SECONDARY ID:
2017-003131-11
- NCT ID:
NCT03659136
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Xentuzumab | | Xentuzumab/everolimus/exemestane |
Placebo | | Placebo/everolimus/exemestane |
Everolimus | | Placebo/everolimus/exemestane |
Exemestane | | Placebo/everolimus/exemestane |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Xentuzumab/everolimus/exemestane | Experimental | | - Xentuzumab
- Everolimus
- Exemestane
|
Placebo/everolimus/exemestane | Placebo Comparator | | - Placebo
- Everolimus
- Exemestane
|
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 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival (PFS) as assessed by central review |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Defined as time from randomisation until disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) or death from any cause, whichever occurs earlier |
Secondary Outcome Measures
Measure: | Overall survival (OS) defined as the time from randomisation until death from any cause |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | Defined as the time from randomisation until death from any cause |
Measure: | Disease control (DC) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Defined as a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-Progressive Disease (Non- CR/Non-PD). SD and Non-CR/Non PD must have a minimum duration of 24 weeks from randomisation. Best overall response is defined according to RECIST version 1.1 and will consider all tumour assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent |
Measure: | Duration of DC is defined as the time from randomisation until the earliest of disease progression or death, among patients with DC |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Defined as the time from randomisation until the earliest of disease progression or death, among patients with DC |
Measure: | Objective response (OR) Defined as a best overall response of complete response (CR) or partial response (PR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Defined as a best overall response of CR or PR. Best overall response is defined according to RECIST version 1.1 and will consider all tumour assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent |
Measure: | Time to pain progression or intensification of pain palliation |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Defined as the time from randomisation until the earliest of a clinically significant increase in pain (≥2-point increase from baseline in the Brief Pain Inventory- Short Form [BPI-SF] Item 3) without a decrease in analgesics use, or intensification in pain palliation (≥2-point increase in the 8-point Analgesic Quantification Algorithm [AQA]), or death |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Boehringer Ingelheim |
Last Updated
August 26, 2021