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Hormone Therapy

MCLA-128 + Standard Therapies for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Merus N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0 or 1.
Women with histologically or cytologically confirmed breast cancer with evidence of metastatic or locally advanced disease not amenable to any local therapy with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during study treatment and up to 30 days after last administration of study drug (median duration of zenocutuzumab exposure was 6.0 weeks for cohort 1 doublet, 19.3 weeks for cohort 1 triplet and 11.8 weeks for cohort 2).
Awards & highlights

Study Summary

This trial is designed to find the best combination of drugs to treat metastatic breast cancer. MCLA-128 will be given in combination with other drugs, either doublet or triplet, in two different groups of patients. There will be a safety run-in for each combination followed by an efficacy expansion. In total, up to 80 patients will be enrolled in the trial.

Who is the study for?
This trial is for women with advanced or metastatic breast cancer that's either HER2-positive/amplified (Cohort 1) or Estrogen Receptor-positive/low HER2 expression (Cohort 2). Participants must have a life expectancy of at least 12 weeks, measurable disease, good heart function, and adequate organ function. They can't join if they have untreated brain metastases, are pregnant/breastfeeding without contraception use, had recent myocardial infarction, require oxygen therapy, or have uncontrolled diseases.Check my eligibility
What is being tested?
The study tests MCLA-128 in combination treatments: For Cohort 1 with HER2+ cancer - MCLA-128 plus trastuzumab ('doublet'), and after safety checks - adding vinorelbine to form a 'triplet'. For Cohort 2 with ER+/low HER2 - MCLA-128 combined with the patient's previous endocrine therapy. Each group has an initial safety phase followed by efficacy expansion.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as infusion-related symptoms and possible organ inflammation. There may also be side effects from chemotherapy like fatigue, nausea, low blood counts increasing infection risk. Specifics will depend on each drug combination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer has spread and cannot be cured with surgery or radiation.
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My cancer can be measured by scans, or I have bone cancer with specific types of lesions.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during study treatment and up to 30 days after last administration of study drug (median duration of zenocutuzumab exposure was 6.0 weeks for cohort 1 doublet, 19.3 weeks for cohort 1 triplet and 11.8 weeks for cohort 2).
This trial's timeline: 3 weeks for screening, Varies for treatment, and during study treatment and up to 30 days after last administration of study drug (median duration of zenocutuzumab exposure was 6.0 weeks for cohort 1 doublet, 19.3 weeks for cohort 1 triplet and 11.8 weeks for cohort 2). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Benefit Rate at 24 Weeks
Secondary outcome measures
Anti-drug Antibodies Serum Titers
Duration of Response (DoR) Per Central Review
Duration of Response (DoR) Per Investigator Assessment
+7 more

Side effects data

From 2023 Phase 2 trial • 105 Patients • NCT03321981
72%
Diarrhoea
46%
Nausea
46%
Asthenia
44%
Neutropenia
33%
Fatigue
31%
Constipation
28%
Anaemia
23%
Abdominal pain
18%
Neutrophil count decreased
18%
Headache
18%
Cough
18%
Weight decreased
15%
Vomiting
15%
Urinary tract infection
15%
Decreased appetite
15%
Neuropathy peripheral
15%
Dyspnoea
15%
Muscle spasms
13%
Pyrexia
13%
Alopecia
13%
Myalgia
10%
Stomatitis
10%
Chest pain
10%
Blood potassium decreased
10%
Dysgeusia
8%
Depression
8%
Mucosal inflammation
8%
Ejection fraction decreased
8%
Oedema peripheral
8%
Back pain
8%
Pruritus
5%
Insomnia
5%
Epistaxis
5%
Thrombocytopenia
5%
Tinnitus
5%
Dry eye
5%
Dysphagia
5%
Gastrointestinal pain
5%
Non-cardiac chest pain
5%
Pain
5%
Influenza
5%
Nasopharyngitis
5%
Aspartate aminotransferase increased
5%
Platelet count decreased
5%
Arthralgia
5%
Dizziness
5%
Paraesthesia
5%
Peripheral motor neuropathy
5%
Urinary incontinence
5%
Hot flush
5%
Gastrooesophageal reflux disease
5%
Chills
5%
Paronychia
5%
Pain in extremity
5%
Peripheral sensory neuropathy
5%
Pain in jaw
5%
Neuralgia
3%
Erysipelas
3%
Tachycardia
3%
Colitis
3%
Somnolence
3%
Hypotension
3%
Orthostatic hypotension
3%
Procedural dizziness
3%
Nail disorder
3%
Onycholysis
3%
Sepsis
3%
Febrile neutropenia
3%
Malabsorption
3%
Osteomyelitis
3%
Leukopenia
3%
Vertigo
3%
Blepharitis
3%
Chalazion
3%
Eye allergy
3%
Eyelid sensory disorder
3%
Photophobia
3%
Visual acuity reduced
3%
Abdominal distension
3%
Aphthous ulcer
3%
Gastritis
3%
Haemorrhoids
3%
Hypoaesthesia oral
3%
Oesophageal pain
3%
Rectal haemorrhage
3%
Toothache
3%
Hyperthermia
3%
Localised oedema
3%
Hypersensitivity
3%
Abscess limb
3%
Lung infection
3%
Mastitis fungal
3%
Oral candidiasis
3%
Oral fungal infection
3%
Pharyngitis
3%
Rash pustular
3%
Sinusitis
3%
Upper respiratory tract infection
3%
Foot fracture
3%
Blood calcium decreased
3%
Blood phosphorus decreased
3%
Blood sodium decreased
3%
Muscular weakness
3%
Amnesia
3%
Nervous system disorder
3%
Restless legs syndrome
3%
Sciatica
3%
Vocal cord paralysis
3%
Stress
3%
Stress urinary incontinence
3%
Breast inflammation
3%
Breast pain
3%
Nasal congestion
3%
Rhinorrhoea
3%
Erythema
3%
Nail discolouration
3%
Rash
3%
Skin ulcer
3%
Infusion related reaction
3%
Seizure
3%
Skin infection
3%
Dehydration
3%
Humerus fracture
3%
Alanine aminotransferase increased
3%
Body temperature increased
3%
Aphasia
3%
Haemoptysis
3%
Telangiectasia
3%
Gait disturbance
3%
Anxiety
3%
Ulcerative keratitis
3%
Iron deficiency
3%
Enthesopathy
3%
Mobility decreased
3%
Abdominal pain upper
3%
Rash maculo-papular
3%
Skin fissures
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 Triplet
Cohort 2
Cohort 1 Doublet

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
zenocutuzumab + endocrine therapy
Group II: Cohort 1 tripletExperimental Treatment3 Interventions
zenocutuzumab + trastuzumab + vinorelbine
Group III: Cohort 1 doubletExperimental Treatment2 Interventions
zenocutuzumab + trastuzumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zenocutuzumab
2018
Completed Phase 2
~110
Fulvestrant
FDA approved
Trastuzumab
FDA approved
Vinorelbine
FDA approved

Find a Location

Who is running the clinical trial?

Merus N.V.Lead Sponsor
7 Previous Clinical Trials
1,260 Total Patients Enrolled
1 Trials studying Breast Cancer
Ernesto Wasserman, MDStudy DirectorMerus N.V.
3 Previous Clinical Trials
526 Total Patients Enrolled
Medical Director: Ernesto Wasserman, MDStudy DirectorMerus N.V.

Media Library

Endocrine therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03321981 — Phase 2
Breast Cancer Research Study Groups: Cohort 1 doublet, Cohort 1 triplet, Cohort 2
Breast Cancer Clinical Trial 2023: Endocrine therapy Highlights & Side Effects. Trial Name: NCT03321981 — Phase 2
Endocrine therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03321981 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What illnesses does Endocrine therapy usually target?

"In cases of disease progression, endocrine therapy is often prescribed to treat malignant neoplasms and tamoxifen. This form of treatment also increases the chance of remission if there is a high risk for recurrence."

Answered by AI

In how many different venues is this research endeavor being conducted?

"Patients can be enrolled in this medical study at 5 different locations, such as Sarah Cannon Research Institute located in Nashville, HCA Midwest Health situated in Kansas City and Tennessee Oncology Chattanooga based in Chattanooga."

Answered by AI

To what extent have Endocrine therapies been explored in other research projects?

"Research into endocrine therapy began in 1995 at the NIH Clinical Center. To date, 810 trials have run their course and 485 separate studies are currently recruiting patients; many of these can be found in Nashville, Tennessee."

Answered by AI

How many individuals are currently receiving treatment in this clinical trial?

"At present, the project has ceased to recruit participants. It was first posted on January 15th 2018 and last updated August 10th 2022. For those interested in similar studies, there are currently 2285 clinical trials recruiting patients with breast cancer as well as 485 endocrine therapy-related studies actively seeking volunteers."

Answered by AI

What perils might be associated with Endocrine therapy?

"Endocrine therapy's safety has been moderately confirmed as it is currently in its second stage of clinical trials. It scored a 2 on our scale because there are some data that confirm the drug's security, yet no documents proving efficacy have surfaced."

Answered by AI

Are there still slots available for individuals to join this experiment?

"Currently, this trial is not recruiting. It was first posted on January 15th 2018 and the last update was August 10th 2022. Those seeking out alternative trials might be interested to know that there are 2285 studies related to breast cancer actively enrolling patients, as well as 485 medical experiments involving endocrine therapy searching for participants."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Feinberg School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~15 spots leftby Mar 2025