Gemcitabine for HER2 Positive Metastatic Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
HER2 Positive Metastatic Breast CancerGemcitabine - Drug
Eligibility
18+
Female
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Study Summary

This trial is testing a new combination of drugs to treat breast cancer, specifically looking at whether it is effective against HER2 positive breast cancer.

Eligible Conditions
  • HER2 Positive Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 years

2 years
overall survival
progression-free survival
response
safety
3 months
progression free

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Gemcitabine Plus Cisplatin (GC)
51%Neutropenia
47%Leukopenia
46%Nausea
43%Vomiting
35%Anaemia
31%Decreased appetite
26%Haemoglobin decreased
26%Fatigue
25%Constipation
25%White blood cell count decreased
24%Neutrophil count decreased
19%Alanine aminotransferase increased
13%Platelet count decreased
12%Rash
10%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Cough
6%Hyponatraemia
6%Lymphopenia
6%Blood creatinine increased
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Dyspnoea
1%Pulmonary embolism
1%Superior vena cava syndrome
1%Cerebral infarction
1%Embolism venous
1%Ischaemic stroke
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01005680) in the Gemcitabine Plus Cisplatin (GC) ARM group. Side effects include: Neutropenia with 51%, Leukopenia with 47%, Nausea with 46%, Vomiting with 43%, Anaemia with 35%.

Trial Design

1 Treatment Group

Gemcitabine, Trastuzumab, and Pertuzuma
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Gemcitabine · No Placebo Group · Phase 2

Gemcitabine, Trastuzumab, and PertuzumaExperimental Group · 3 Interventions: Trastuzumab, Pertuzumab, Gemcitabine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Pertuzumab
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,493 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,497 Previous Clinical Trials
564,634 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,361 Previous Clinical Trials
1,068,038 Total Patients Enrolled
Hartford HealthCareOTHER
6 Previous Clinical Trials
1,031 Total Patients Enrolled
Chau Dang, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
232 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

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