MEN1611-01, B-PRECISE-01, Dose-Escalation, Breast Cancer
Research type
Research Study
Full title
Open label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined with Trastuzumab ± Fulvestrant, in Subjects with PIK3CA Mutated HER2 positive Locally Recurrent Unresectable (advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy.
IRAS ID
242689
Contact name
Angela Capriati
Contact email
Sponsor organisation
Menarini Ricerche S.p.A.
Eudract number
2017-004631-36
Duration of Study in the UK
2 years, 4 months, 6 days
Research summary
This study will consider the study drug in women with breast cancer which contains “mutated” PIK3CA (a protein involved in the regulation of cell survival and reproduction), who have been treated and did not respond well (or the cancer came back) following at least two types of treatment for HER2 positive breast cancer.
The primary purpose of this phase Ib study is to establish the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of MEN1611 in combination with trastuzumab ± fulvestrant. An ascending dose(16 mg, 32 mg and 48 mg twice daily) will be given to the trial subjects (females aged over 18 years who have confirmed to have breast cancer).
Secondary purpose is to determine how well the study drug works when taken in combination with trastuzumab alone and when taken in combination with both trastuzumab and fulvestrant. This study will also look at how safe the study drug is to treat subjects.
The clinical research study will also look at the following:
• how safe the study drug is and how well the body handles any side effects or discomfort that the study drug may cause;
• how well the study drug works when combined with trastuzumab alone and when combined with both trastuzumab and fulvestrant;
• what the patient's body does to the study drug (this is known as “pharmacokinetics” or “PK”) when taken in combination with trastuzumab alone and when taken in combination with both trastuzumab and fulvestrant.The overall study duration will depend on the completion of the
escalating dose levels and the number of subjects in approximately 25 European sites.The study drug comes in the form of red 16 mg capsules that should be taken by mouth twice a day with a glass of water in fasting conditions.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0197
Date of REC Opinion
22 Jun 2018
REC opinion
Further Information Favourable Opinion