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Alkylating agents
Chemotherapy + Trastuzumab for Breast Cancer
Phase 3
Waitlist Available
Led By Louis Fehrenbacher
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HER2 status of the primary tumor must be evaluated prior to randomization
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying giving chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
Who is the study for?
This trial is for women with invasive breast cancer who've had surgery. They must have a life expectancy of at least 10 years, not counting their cancer, and be in good health otherwise. Participants need proper organ function and no history of certain cancers or treatments within the last 5 years. Women must agree to avoid pregnancy during and after the trial for specified periods.Check my eligibility
What is being tested?
The study compares chemotherapy alone versus chemotherapy with trastuzumab (a monoclonal antibody) post-surgery in treating breast cancer. It aims to determine if adding trastuzumab improves outcomes by preventing tumor growth or spread more effectively than chemotherapy alone.See study design
What are the potential side effects?
Chemotherapy can cause nausea, hair loss, fatigue, increased risk of infection, and other side effects depending on the drugs used. Trastuzumab may lead to heart problems, allergic reactions, flu-like symptoms, headache, trouble sleeping, and dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer's HER2 status has been checked.
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My breast cancer is invasive and only in one breast.
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I have provided tumor samples from my breast surgery.
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My cancer stage fits the specific criteria set by the AJCC 7th edition.
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My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.
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My last breast cancer surgery was within the last 84 days.
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I am expected to live more than 10 years, not counting my breast cancer.
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I have had either a total mastectomy or a lumpectomy.
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I have had a procedure to check the status of my lymph nodes.
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My liver tests are high but I don't have liver cancer.
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I agree to use non-hormonal birth control during and 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 ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Patients Alive and Free From Invasive Disease (IDFS)
Secondary outcome measures
Change in HER2 mRNA Level
Fcgamma Receptor Polymorphism
Percentage of Patients Alive (Overall Survival)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (chemotherapy, trastuzumab)Experimental Treatment8 Interventions
GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (chemotherapy)Active Control7 Interventions
GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin
2012
Completed Phase 3
~7940
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Paclitaxel
2011
Completed Phase 4
~5380
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,929,883 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
97,582 Total Patients Enrolled
Louis FehrenbacherPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had breast cancer in both breasts at the same time or at different times.Your kidney function test within 6 weeks before the study must be within the normal range.You have signed a consent form that has been approved by a review board and follows the rules set by the government and institution.I am currently on hormone therapy for my cancer.My diabetes is not well-managed.My cancer's HER2 status has been checked.I have not had any cancer other than breast cancer in the last 5 years.My breast cancer is either ER and PgR negative, or it's ER positive with a high grade or score, or it has spread to nearby tissues.I am currently using hormone therapy.Your alkaline phosphatase level should be no more than 2.5 times the upper limit of normal.My breast cancer is invasive and only in one breast.I cannot take corticosteroids due to my health condition.I have provided tumor samples from my breast surgery.My cancer stage fits the specific criteria set by the AJCC 7th edition.My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.I am expected to live more than 10 years, not counting my breast cancer.I take 10 mg or more of corticosteroids daily.I have received chemotherapy or HER2 therapy for my current breast cancer.I have had breast cancer or DCIS on the same side before.My tumor samples from breast surgery can be used for research.You need to have a certain number of a type of white blood cell called neutrophils in your blood.My last breast cancer surgery was within the last 84 days.Your hemoglobin level must be 10 grams per deciliter or higher.My cancer has spread to other parts of my body.My heart condition allows me to use the drugs in the treatment plan.My blood pressure is not too high based on specific criteria.I am expected to live more than 10 years, not counting my breast cancer.I have a lung condition that makes it hard for me to breathe.Your AST level in the blood test must be no more than 1.5 times the upper limit of normal.Your heart's pumping function (LVEF) must be checked within 90 days before joining the study.I have been treated with anthracyclines, taxanes, or trastuzumab for cancer.My primary tumor was tested for HER2.I have had either a total mastectomy or a lumpectomy.Your doctor needs to have tested the primary tumor for estrogen receptor (ER) before you can join the study.You need to have at least 100,000 platelets per cubic millimeter of blood.I have had a procedure to check the status of my lymph nodes.Your total bilirubin level must be within the normal range for the lab.My liver tests are high but I don't have liver cancer.I have active hepatitis B or C with abnormal liver tests.I agree to use non-hormonal birth control during and after the study.I don't have any other serious illnesses that would stop me from participating in the study.I am fully active or restricted in physically strenuous activity but can do light work.I have an ongoing infection or need long-term antibiotics.You have mental health or addiction issues that would make it difficult for you to meet the study requirements.I have a moderate to severe nervous system condition.I have had or will have whole or partial breast radiation before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (chemotherapy, trastuzumab)
- Group 2: Arm I (chemotherapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What conditions does Doxorubicin commonly treat?
"Doxorubicin is a medication used to treat esophageal neoplasms malignant. It is also effective for other conditions, like newly diagnosed therapy-related acute myeloid leukemia, lymphoma, and acute lymphoblastic leukemia (all)."
Answered by AI
What other published works are there on Doxorubicin's effects?
"Doxorubicin was first evaluated in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, 3842 clinical trials have been completed while 2204 are still recruiting patients. The majority of these active studies are based in Saint Joseph, Michigan."
Answered by AI
From how many different places is this drug trial being controlled?
"There are 100 available for this clinical trial including Lakeland Medical Center Saint Joseph in Saint Joseph, Hennepin County Medical Center in Minneapolis, and Saint Francis Medical Center in Cape Girardeau."
Answered by AI
Are the procedures in this clinical trial new and innovative?
"Doxorubicin has been studied since Alfacell's research in 1997. There are currently 2204 active studies involving doxorubicin across 87 countries and 4059 cities."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
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