Clinical Trials /

MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

NCT03767335

Description:

The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
  • Official Title: Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

Clinical Trial IDs

  • ORG STUDY ID: MEN1611-01
  • SECONDARY ID: 2017-004631-36
  • NCT ID: NCT03767335

Conditions

  • Advanced or Metastatic Breast Cancer

Interventions

DrugSynonymsArms
MEN1611MEN1611
TrastuzumabMEN1611
FulvestrantMEN1611

Purpose

The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

Detailed Description

      This Phase Ib study will investigate the safety and anti-tumor activity of daily oral doses
      MEN1611 in combination with Trastuzumab with/without Fulvestrant in female patients affected
      by advanced or metastatic HER2-positive breast cancer. Fulvestrant will be added to the
      post-menopausal patients with hormone-sensitive disease.

      MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide
      3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611 given
      as single agent was assessed in a phase I trial in patients with advanced solid tumors.

      This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of MEN1611
      given in combination with Trastuzumab with/without Fulvestrant.

      The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor
      activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review
      Committee.
    

Trial Arms

NameTypeDescriptionInterventions
MEN1611ExperimentalMEN1611 + Trastuzumab +/- Fulvestrant
  • MEN1611
  • Trastuzumab
  • Fulvestrant

Eligibility Criteria

        Main Inclusion Criteria:

          -  Histologically confirmed invasive adenocarcinoma of the breast

          -  Known HER2+ breast cancer

          -  Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample

          -  > 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab

          -  Radiological documented evidence of progressive disease

          -  Life expectancy ≥ 12 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

        Main Exclusion Criteria:

          -  Previous treatment with PI3K inhibitors

          -  Brain metastases untreated, unless treated > 4 weeks and only if clinically stable and
             not receiving corticosteroids

          -  History of clinically significant bowel disease

          -  ≥ grade 2 diarrhoea

          -  History of significant, uncontrolled, or active cardiovascular disease

          -  Any serious and/or unstable pre-existing psychiatric or neurologic illness or other
             conditions that could interfere with patient's safety

          -  Not controlled diabetes mellitus (glycated haemoglobin [HbA1c] >7%) and fasting plasma
             glucose >120 mg/dL

          -  Concurrent chronic treatment with steroids, as immunosuppressant, or another
             immunosuppressive agent
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D)
Time Frame:28 Days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Treatment emergent adverse events (TEAEs)
Time Frame:2 years
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Menarini Group

Trial Keywords

  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • PI3K inhibitor
  • HER2-positive

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