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Alkylating agents, Anti-tumor antibiotic, Anti-metabolites
Trastuzumab for Endometrial Cancer
Phase 2
Waitlist Available
Led By Alessandro D Santin, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing whether adding the drug trastuzumab to standard chemotherapy improves progression-free survival in patients with a specific type of uterine cancer.
Eligible Conditions
- Endometrial Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival Differences Between Treatment Arms.
Secondary outcome measures
To Assess Objective Response Rate (ORR)
To Assess Overall Survival (OS)
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TrastuzumabExperimental Treatment1 Intervention
Monoclonal antibody
Group II: Carboplatin/PaclitaxelActive Control1 Intervention
Chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,380 Total Patients Enrolled
2 Trials studying Endometrial Cancer
31 Patients Enrolled for Endometrial Cancer
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,082 Total Patients Enrolled
6 Trials studying Endometrial Cancer
405 Patients Enrolled for Endometrial Cancer
Alessandro D Santin, M.D.Principal InvestigatorYale University
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