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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03767335|
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Breast Cancer||Drug: MEN1611 Drug: Trastuzumab Drug: Fulvestrant||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|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)|
|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 :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
MEN1611 + Trastuzumab +/- Fulvestrant
MEN1611 oral dose administered twice daily for a continuous 28-day cycle
Trastuzumab solution for infusion administered weekly via IV
Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D) [ Time Frame: 28 Days ]
- Treatment emergent adverse events (TEAEs) [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT03767335
|Contact: Angela Capriati Corporate Director, PhD MD||+390555680 ext firstname.lastname@example.org|
|Contact: Fabiola Amair Clinical Research Physician||+390555680 ext email@example.com|
|Study Chair:||Martine Piccart, MD PhD||Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium|