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

Primary Purpose

Advanced or Metastatic Breast Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MEN1611
Trastuzumab
Fulvestrant
Sponsored by
Menarini Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Breast Cancer focused on measuring Advanced Breast Cancer, Metastatic Breast Cancer, PI3K inhibitor, HER2-positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Holy Cross Hospital Inc.
  • Detroit Clinical Research Center
  • Washington University
  • Cliniques Universitaires Saint-Luc
  • Institut Jules Bordet
  • UZ Leuven
  • Centre Georges François Leclerc
  • Centre Oscar Lambret
  • Institut Régional du Cancer de Montpellier
  • ICO - Site René Gauducheau
  • Institut Claudius Regaud Oncopole
  • Institut Gustave Roussy
  • Azienda Ospedaliero Universitaria Mater Domini
  • Istituto Clinico Humanitas
  • Istituto Europeo di Oncologia (IEO)
  • Ospedale San Raffaele
  • Hospital Clínic i Provincial de Barcelona
  • Hospital Universitari Vall d'Hebron
  • Centro Integral Oncologico Clara Campal
  • Hospital General Universitario Gregorio Marañon
  • START Madrid Fundacion Jimenez Diaz
  • Hospital Clínico Universitario Virgen de la Victoria
  • Hospital Universitario Virgen del Rocío
  • Velindre Cancer Centre
  • Sarah Cannon Research Institute UK
  • University College London Hospitals
  • The Christie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MEN1611

Arm Description

MEN1611 + Trastuzumab +/- Fulvestrant

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D)

Secondary Outcome Measures

Treatment emergent adverse events (TEAEs)
Progression Free Survival
Overall Survival

Full Information

First Posted
December 5, 2018
Last Updated
May 23, 2023
Sponsor
Menarini Group
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1. Study Identification

Unique Protocol Identification Number
NCT03767335
Brief Title
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
Acronym
B-PRECISE-01
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Breast Cancer
Keywords
Advanced Breast Cancer, Metastatic Breast Cancer, PI3K inhibitor, HER2-positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Step 1 Dose escalation / Step 2 Cohort expansion in two selected breast cancer sub-populations
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEN1611
Arm Type
Experimental
Arm Description
MEN1611 + Trastuzumab +/- Fulvestrant
Intervention Type
Drug
Intervention Name(s)
MEN1611
Intervention Description
MEN1611 oral dose administered twice daily for a continuous 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Trastuzumab solution for infusion administered weekly via IV
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D)
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Treatment emergent adverse events (TEAEs)
Time Frame
2 years
Title
Progression Free Survival
Time Frame
2 years
Title
Overall Survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 >126 mg/dL Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Piccart, MD PhD
Organizational Affiliation
Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
Holy Cross Hospital Inc.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Centre Oscar Lambret
City
Lille Cedex
Country
France
Facility Name
Institut Régional du Cancer de Montpellier
City
Montferrier Sur Lez
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint-Herblain
Country
France
Facility Name
Institut Claudius Regaud Oncopole
City
Toulouse
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif cedex
Country
France
Facility Name
Azienda Ospedaliero Universitaria Mater Domini
City
Catanzaro
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Milan
Country
Italy
Facility Name
Istituto Europeo di Oncologia (IEO)
City
Milan
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
Country
Italy
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
START Madrid Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
Country
United Kingdom
Facility Name
The Christie
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

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

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