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Chemotherapy + Trastuzumab for Early-Stage HER2 Positive Breast Cancer
Phase 2
Waitlist Available
Led By Amulya Yellala, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All included subjects must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram
Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and efficacy of giving cyclophosphamide, paclitaxel, and trastuzumab after surgery to patients with early-stage HER2/neu positive breast cancer.
Who is the study for?
This trial is for women with stage I-II HER2/neu positive breast cancer post-surgery. Participants must have normal organ function, not be pregnant or nursing, agree to use birth control, and have no history of severe illnesses or conditions that could interfere with the study.Check my eligibility
What is being tested?
The effectiveness and side effects of cyclophosphamide, paclitaxel, and trastuzumab are being tested after surgery in patients with early-stage HER2-positive breast cancer. The goal is to prevent cancer recurrence by using these chemotherapy drugs and a monoclonal antibody.See study design
What are the potential side effects?
Potential side effects include nausea, hair loss, fatigue from chemotherapy drugs like cyclophosphamide and paclitaxel; allergic reactions or heart issues may occur due to trastuzumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well, with an ejection fraction over 50%.
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I have been newly diagnosed with early-stage HER2 positive breast cancer.
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I am not pregnant or nursing and agree to use birth control during and up to 6 months after the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade 3/4 cardiotoxicity, graded according to the NCI CTCAE v4.03
Incidence of grade 3/4 nausea/vomiting, graded according to the NCI CTCAE v4.03
Incidence of inability to complete treatment, defined as a patient that requires a lower dose of therapy (defined as dose lowered by 50%), or a postponement of scheduled treatment of longer than 28 days, or discontinuation of treatment for any reason
+3 moreSide 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
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, paclitaxel, trastuzumab)Experimental Treatment4 Interventions
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Paclitaxel
FDA approved
Trastuzumab
FDA approved
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
537 Previous Clinical Trials
1,143,934 Total Patients Enrolled
15 Trials studying Breast Cancer
1,006,302 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Amulya Yellala, MDPrincipal InvestigatorUniversity of Nebraska
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your alkaline phosphatase level should not be more than 1.5 times the upper limit of normal within 30 days before joining the trial.Your total bilirubin level has to be within a certain range in the last 30 days before joining the study.Your liver function tests should not be more than 1.5 times the upper limit of normal within the last 30 days before joining the trial.My heart pumps well, with an ejection fraction over 50%.I have had cancer before, but it was either skin cancer treated successfully or a non-spreading type.I can come back for treatment and follow-up when needed.I am able to follow the treatment plan as directed.Your white blood cell count must be at least 1,500 per microliter within the last 30 days before you join the study.Your platelet count is 150,000/microliter or higher within the past 30 days before joining the study.Your hemoglobin level has been higher than 11 gm/dl in the last 30 days before joining the study.I am not pregnant or nursing and agree to use birth control during and up to 6 months after the study.I am a woman who can have children and have a recent negative pregnancy test.I have moderate numbness or pain in my hands or feet.I have had chemotherapy in the past.My breast cancer has spread to other parts of my body.I do not have any serious infections or conditions that would prevent me from receiving chemotherapy.I do not have any health issues that could affect my participation in the study.I do not have HIV or active hepatitis.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I have been newly diagnosed with early-stage HER2 positive breast cancer.I am fully active or restricted in physically strenuous activity but can do light work.Your kidney function test should show a creatinine level within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, paclitaxel, trastuzumab)
Awards:
This trial has 3 awards, including:- 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 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you have any information on other times Trastuzumab has been used in medical trials?
"1795 clinical trials involving Trastuzumab are ongoing. Of these, 392 are in Phase 3. Although most of the studies for Trastuzumab are based in Seattle, Washington, there are 73264 locations running trials for this treatment."
Answered by AI
To what medical condition is Trastuzumab most often given?
"Trastuzumab is an effective treatment against non-small cell lung cancer, bladder cancer that has metastasized, and inflammatory breast cancer."
Answered by AI
Is this research opportunity still accepting volunteers?
"According to the clinicaltrials.gov website, this study is no longer looking for patients to enroll. This particular trial was first posted on December 11th, 2015 and was edited most recently on September 1st, 2021. There are, however, 4158 other trials that are still recruiting patients."
Answered by AI
Has Trastuzumab been cleared by the FDA?
"Trastuzumab falls into the Phase 2 category, so there is some evidence of safety, but none for efficacy. Therefore, it received a score of 2."
Answered by AI
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