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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

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ClinicalTrials.gov Identifier: NCT03659136
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 3, 2018
First Posted Date  ICMJE September 6, 2018
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE November 28, 2018
Estimated Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03659136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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 Post-menopausal Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Xentuzumab
    Intravenous infusion
  • Drug: Placebo
    Intravenous infusion
  • Drug: Everolimus
    Tablet
  • Drug: Exemestane
    Tablet
Study Arms  ICMJE
  • Experimental: Xentuzumab/everolimus/exemestane
    Interventions:
    • Drug: Xentuzumab
    • Drug: Everolimus
    • Drug: Exemestane
  • Placebo Comparator: Placebo/everolimus/exemestane
    Interventions:
    • Drug: Placebo
    • Drug: Everolimus
    • Drug: Exemestane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2019)
80
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2018)
90
Estimated Study Completion Date  ICMJE January 12, 2022
Estimated Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Greece,   Italy,   Portugal,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03659136
Other Study ID Numbers  ICMJE 1280-0022
2017-003131-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP