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MAB HER 2 (HERCEPTIN) for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast CancerMAB HER 2 (HERCEPTIN) - Biological
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response in patients with breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: at week 19 or at the discretion of the physician

13 weeks
The maximum tolerated dose over four dose levels
Week 19
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.

Trial Safety

Safety Progress

1 of 3

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1
Cemiplimab
2
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Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Headache
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Pigmentation disorder
6%Insomnia
6%Transaminases increased
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

1 Treatment Group

1
1 of 1

Experimental Treatment

13 Total Participants · 1 Treatment Group

Primary Treatment: MAB HER 2 (HERCEPTIN) · No Placebo Group · Phase 1

1
Biological
Experimental Group · 1 Intervention: MAB HER 2 (HERCEPTIN) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 19 or at the discretion of the physician

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,500 Total Patients Enrolled
192 Trials studying Breast Cancer
93,756 Patients Enrolled for Breast Cancer
Carlos Dos Anjos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Jedd Wolchok, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
30 Total Patients Enrolled
Mark Robson, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
9,271 Total Patients Enrolled
6 Trials studying Breast Cancer
7,961 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have breast cancer that is not more than 36 months post completion of adjuvant therapy.
You have Stage IV breast cancer with no evidence of disease or stable disease
References

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