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
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
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
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
Mark “Yes” if the following statements are true for you:References
- Iyengar NM, Smyth LM, Lake D, Gucalp A, Singh JC, Traina TA, DeFusco P, Fornier MN, Goldfarb S, Jhaveri K, Modi S, Troso-Sandoval T, Patil S, Ulaner GA, Jochelson M, Norton L, Hudis CA, Dang CT. Efficacy and Safety of Gemcitabine With Trastuzumab and Pertuzumab After Prior Pertuzumab-Based Therapy Among Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Phase 2 Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1916211. doi: 10.1001/jamanetworkopen.2019.16211.
- 2015. "Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02252887.
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Conditions
Cancer Related
Treatments