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Anti-metabolites

Margetuximab for Breast Cancer (SOPHIA Trial)

Phase 3
Waitlist Available
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Awards & highlights

SOPHIA Trial Summary

This trial will compare two treatments for HER2-positive breast cancer to see which one extends patients' lives without the disease progressing.

Eligible Conditions
  • Cancer
  • Breast Cancer

SOPHIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SOPHIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Grade 3 or Higher Infusion Related Reactions
Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).
Progression-free Survival (PFS) as Determined by Independent Radiological Review.
Secondary outcome measures
Infusion Rate Sub-study All Safety
To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review.

Side effects data

From 2022 Phase 3 trial • 624 Patients • NCT02492711
42%
Fatigue
33%
Nausea
27%
Neutropenia
26%
Diarrhoea
21%
Vomiting
19%
Pyrexia
19%
Asthenia
19%
Constipation
19%
Headache
18%
Anaemia
18%
Alopecia
16%
Cough
14%
Decreased appetite
13%
Dyspnoea
13%
Infusion related reaction
13%
Palmar-plantar erythrodysaesthesia syndrome
12%
Neutrophil count decreased
12%
Pain in extremity
11%
Stomatitis
11%
Arthralgia
10%
Mucosal inflammation
10%
Alanine aminotransferase increased
10%
Neuropathy peripheral
10%
Dizziness
9%
Abdominal pain
9%
Urinary tract infection
9%
Back pain
8%
Oedema peripheral
8%
Thrombocytopenia
8%
Aspartate aminotransferase increased
8%
White blood cell count decreased
8%
Upper respiratory tract infection
8%
Nasopharyngitis
8%
Abdominal pain upper
7%
Epistaxis
7%
Myalgia
7%
Rash
7%
Influenza like illness
6%
Dyspepsia
6%
Dysgeusia
6%
Weight decreased
6%
Hypokalaemia
6%
Muscle spasms
6%
Peripheral sensory neuropathy
6%
Insomnia
5%
Pruritus
2%
Pneumonia
2%
Febrile neutropenia
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Margetuximab Plus Chemotherapy
Trastuzumab Plus Chemotherapy
Margetuximab Infusion Substudy

SOPHIA Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Margetuximab plus chemotherapyExperimental Treatment2 Interventions
Margetuximab 15 mg/kg every 21 days
Group II: Margetuximab Infusion Sub-studyExperimental Treatment2 Interventions
Margetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2.
Group III: Trastuzumab plus chemotherapyActive Control2 Interventions
Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physician's choice of chemotherapy.
2015
Completed Phase 3
~630
Margetuximab
FDA approved

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
4,470 Total Patients Enrolled
4 Trials studying Breast Cancer
329 Patients Enrolled for Breast Cancer
Minori Rosales, M.D., Ph.D.Study DirectorMacroGenics
Stephen L Eck, M.D., Ph.D.Study DirectorMacroGenics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
2015. "Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02492711.
~65 spots leftby Apr 2025
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