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Anti-metabolites

Gemcitabine + Trastuzumab + Pertuzumab for Breast Cancer

Phase 2
Waitlist Available
Led By Chau Dang, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable
ECOG performance status 0 -1
Must not have
History of prior ≥ G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
History of hepatitis B or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions

Summary

This trial is testing a combination of three drugs to treat advanced HER2 positive breast cancer in women who have already tried other treatments. The combination includes a chemotherapy drug called gemcitabine and two drugs, trastuzumab and pertuzumab, that stop cancer cells from growing. Pertuzumab was originally developed independently from trastuzumab and later found to work well together when combined with trastuzumab. The goal is to see if this new combination is more effective and safe.

Who is the study for?
This trial is for adults with stage IV HER2-positive breast cancer who've had up to three prior chemotherapies in the metastatic setting and have previously been treated with trastuzumab + pertuzumab or pertuzumab-based therapy. Participants must have a good performance status, stable brain lesions if present, normal heart function, and acceptable blood counts and liver function. Pregnant individuals or those with severe past reactions to study drugs, hepatitis B/C, or recent serious heart issues cannot join.
What is being tested?
The trial is testing a combination of gemcitabine (a standard chemotherapy drug) with two targeted therapies—trastuzumab (Herceptin) and pertuzumab (Perjeta)—to see how effective they are against advanced HER2-positive breast cancer after previous similar treatments. It's a Phase II study focusing on effectiveness as well as safety.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills; damage to organs like the heart; lowered blood cell counts leading to increased infection risk; fatigue; liver enzyme changes; nausea; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is HER2 positive, confirmed by a lab test.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have been treated with trastuzumab and pertuzumab for my cancer.
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I have stage IV breast cancer that is HER2 positive.
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I have had 3 or fewer chemotherapy treatments for cancer that has spread.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a severe allergic reaction to trastuzumab or pertuzumab.
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I have had hepatitis B or C in the past.
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I haven't had serious heart issues like a heart attack or unstable angina in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
progression free
Secondary study objectives
overall survival
progression-free survival
response
+1 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
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%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gemcitabine, Trastuzumab, and PertuzumaExperimental Treatment3 Interventions
The regimen will consist of gemcitabine at 1000mg/m\^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it \< 6 weeks prior to Cycle 1 Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Pertuzumab
FDA approved
Trastuzumab
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer, such as chemotherapy and HER2 receptor inhibition, work through distinct mechanisms. Chemotherapy drugs like Gemcitabine disrupt DNA replication in rapidly dividing cancer cells, causing cell death. HER2 inhibitors, including Trastuzumab and Pertuzumab, target the HER2 protein that is overexpressed in some breast cancers, blocking growth signals and promoting cancer cell death. This combination is crucial for breast cancer patients as it leverages the broad efficacy of chemotherapy with the precision of targeted therapy, potentially improving treatment effectiveness and patient outcomes.
Heart Failure in Relation to Tumor-Targeted Therapies and Immunotherapies.Targeted therapy for breast cancer in older patients.Pharmacokinetics, clinical indications, and resistance mechanisms in molecular targeted therapies in cancer.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheIndustry Sponsor
2,450 Previous Clinical Trials
1,095,438 Total Patients Enrolled
159 Trials studying Breast Cancer
90,650 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,555 Previous Clinical Trials
569,255 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,906 Total Patients Enrolled
207 Trials studying Breast Cancer
83,999 Patients Enrolled for Breast Cancer
~4 spots leftby Oct 2025
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