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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
progression free
Secondary outcome measures
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%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
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)

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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheIndustry Sponsor
2,428 Previous Clinical Trials
1,089,009 Total Patients Enrolled
160 Trials studying Breast Cancer
91,467 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,577 Total Patients Enrolled
203 Trials studying Breast Cancer
81,137 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,644 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the United States Food and Drug Administration sanctioned Gemcitabine for clinical use?

"The safety rating of Gemcitabine is at a 2, reflecting the lack of efficacy data despite some support for its safety which comes from Phase 2 trials."

Answered by AI

How many individuals are currently participating in this clinical research?

"This clinical trial is no longer recruiting new participants; it was initially listed on December 1st 2015, with the last update occurring October 3rd 2022. For those looking for similar trials, there are currently 2289 metastatic breast cancer studies involving HER2 positive cells and 637 Gemcitabine research efforts actively seeking enrollees at this time."

Answered by AI

What other experiments have been performed with Gemcitabine as the focal point?

"First studied in 1999 at Ospedale di Circolo e Fondazione Macchi, gemcitabine has been subject to 1235 completed clinical trials. At the moment, 637 active investigations are taking place with a substantial number of these being performed out of Harrison, New york."

Answered by AI

In what geographic areas is this experiment taking place?

"Patients can enroll in this trial at varied sites, such as Memorial Sloan Kettering Westchester in Harrison, Memorial Sloan Kettering Monmouth in Middletown, and Hartford Healthcare Cancer Institute @ Hartford Hospital. Additionally, there are two other locations where enrollment is possible."

Answered by AI

Are there currently opportunities to participate in this experiment?

"Currently, this research project is not recruiting patients. Initial posting was on the 12th of January 2015 and last updated on 3rd October 2022. However, for those seeking to participate in alternative studies related to metastatic breast cancer with her2 positive, there are 2289 trials available; 637 for Gemcitabine-based treatments."

Answered by AI

What maladies is Gemcitabine frequently administered to address?

"Gemcitabine is a frequently prescribed medication for patients with inflammatory breast cancer (IBC), as well as those suffering from small cell lung cancer (SCLC), head and neck carcinoma, and cervical cancers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
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.
~2 spots leftby Sep 2024
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