MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT03767335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 identification
- NCT ID
- NCT03767335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Menarini Group
- Industry
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Interventions
- Fulvestrant Drug
- MEN1611 Drug
- Trastuzumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2018
- Primary completion
- Feb 22, 2024
- Completion
- Feb 22, 2024
- Last update posted
- Jun 25, 2025
2018 – 2024
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Holy Cross Hospital Inc. | Fort Lauderdale | Florida | 33308 | — |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | — |
| Washington University | St Louis | Missouri | 63130 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03767335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2025 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03767335 live on ClinicalTrials.gov.