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MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
NCT03321981 · View on ClinicalTrials.gov ↗
Study Summary
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Endocrine therapy
- DRUG Vinorelbine
- DRUG Zenocutuzumab
Study Locations (20)
Other
- Institut Jules Bordet — Brussels
- Grand Hôpital de Charleroi (GHdC) — Charleroi
- UZ Leuven — Leuven
- Hôpital Jean Minjoz — Besançon
- Centre Jean Perrin — Clermont-Ferrand
- Centre Georges-Francois Leclerc — Dijon
- Centre Léon Bérard — Lyon
- Institut Paoli Calmette — Marseille
- Centre René Huguenin — Saint-Cloud
- Centre Paul Strauss — Strasbourg
- Centre Claudius Régaud — Toulouse
- Institute Gustave Roussy — Villejuif
- Champalimaud Clinical Centre — Lisbon
- Hopistal San Antonio — Porto
- Instituto Português Oncologia — Porto
- Vall D'Hebron Institute of Oncology (VHIO) — Barcelona
California
- Cedars-Sinai Medical Center — Los Angeles
Kansas
- HCA Midwest Health — Kansas City
Tennessee
- Sarah Cannon Research Institute — Nashville
North Holland
- Netherlands Cancer Institute NKI — Amsterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2023-07-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03321981
The ClinicalTrials.gov registry entry for NCT03321981 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merus B.V., which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer Metastatic appearing as the primary indexed condition, and to 4 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03321981 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03321981 about?
NCT03321981 is a clinical study titled "MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.". A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (M...
What is the current status of trial NCT03321981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2018-01-15. Estimated completion is 2023-07-26.
What conditions does trial NCT03321981 study?
This clinical trial studies the following conditions: Breast Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03321981?
The interventions under investigation include: Trastuzumab (DRUG), Endocrine therapy (DRUG), Vinorelbine (DRUG), Zenocutuzumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03321981?
This trial is sponsored by Merus B.V., which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03321981 being conducted?
This trial has 20 study locations across California, Kansas, Tennessee, North Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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