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
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ClinicalTrials.gov Identifier: NCT03659136 |
Recruitment Status :
Recruiting
First Posted : September 6, 2018
Last Update Posted : February 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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Breast Neoplasms | Drug: Xentuzumab Drug: Placebo Drug: Everolimus Drug: Exemestane | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 28, 2018 |
Estimated Primary Completion Date : | December 15, 2021 |
Estimated Study Completion Date : | November 3, 2022 |

Arm | Intervention/treatment |
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Experimental: Xentuzumab/everolimus/exemestane |
Drug: Xentuzumab
Intravenous infusion Drug: Everolimus Tablet Drug: Exemestane Tablet |
Placebo Comparator: Placebo/everolimus/exemestane |
Drug: Placebo
Intravenous infusion Drug: Everolimus Tablet Drug: Exemestane Tablet |
- Progression free survival (PFS) as assessed by central review [ Time Frame: Up to 24 months ]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
- Overall survival (OS) defined as the time from randomisation until death from any cause [ Time Frame: Up to 3 years ]Defined as the time from randomisation until death from any cause
- Disease control (DC) [ Time Frame: Up to 24 months ]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
- 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 ]Defined as the time from randomisation until the earliest of disease progression or death, among patients with DC
- Objective response (OR) Defined as a best overall response of complete response (CR) or partial response (PR) [ Time Frame: Up to 24 months ]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
- Time to pain progression or intensification of pain palliation [ Time Frame: Up to 24 months ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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).
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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).
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659136
Contact: Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT03659136 |
Other Study ID Numbers: |
1280-0022 2017-003131-11 ( EudraCT Number ) |
First Posted: | September 6, 2018 Key Record Dates |
Last Update Posted: | February 23, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
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Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Everolimus Exemestane Antineoplastic Agents Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |