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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03767335
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : May 24, 2023
Information provided by (Responsible Party):
Menarini Group

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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Breast Cancer Drug: MEN1611 Drug: Trastuzumab Drug: Fulvestrant Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Step 1 Dose escalation / Step 2 Cohort expansion in two selected breast cancer sub-populations
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : December 21, 2023
Estimated Study Completion Date : December 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: MEN1611
MEN1611 + Trastuzumab +/- Fulvestrant
Drug: MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle

Drug: Trastuzumab
Trastuzumab solution for infusion administered weekly via IV

Drug: Fulvestrant
Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D) [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs) [ Time Frame: 2 years ]
  2. Progression Free Survival [ Time Frame: 2 years ]
  3. Overall Survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03767335

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Sponsors and Collaborators
Menarini Group
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Study Chair: Martine Piccart, MD PhD Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium
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Responsible Party: Menarini Group Identifier: NCT03767335    
Other Study ID Numbers: MEN1611-01
2017-004631-36 ( EudraCT Number )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023

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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
Keywords provided by Menarini Group:
Advanced Breast Cancer
Metastatic Breast Cancer
PI3K inhibitor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs