The trial is taking place at:
D

Detroit Clinical Research Center | Farmington Hills, MI

Veeva-enabled site

MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01)

Menarini logo

Menarini

Status and phase

Completed
Phase 1

Conditions

Advanced or Metastatic Breast Cancer

Treatments

Drug: Fulvestrant
Drug: MEN1611
Drug: Trastuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03767335
2017-004631-36 (EudraCT Number)
MEN1611-01

Details and patient eligibility

About

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

Full 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 and male 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 >126 mg/dL
  • Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

62 participants in 1 patient group

MEN1611
Experimental group
Description:
MEN1611 + Trastuzumab +/- Fulvestrant
Treatment:
Drug: Trastuzumab
Drug: MEN1611
Drug: Fulvestrant

Trial contacts and locations

27

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems