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CompletedLast updated: 14 May 2024

Xenera-1: This phase II trial is evaluating a new form of immunotherapy (xentuzumab) to see whether it enhances combination treatment with a chemotherapy drug (Everolimus) and hormone therapy drug (Exemestane) in patients with hormone receptor positive (HR+), HER2- breast cancer that has spread to other parts of the bodyA 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

Clinical summary

Summary

Participants in this trial will be randomised to receive either intravenous xentuzumab or placebo, in combination with oral everolimus and oral exemestane.

Conditions

This trial is treating patients with HR+ / HER2- Breast Cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

II

Trial Acronym

Xenera-1

More information

Trial Identifiers

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Trial sponsor

Boehringer Ingelheim

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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