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Chemotherapy + Trastuzumab for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm II (chemotherapy, trastuzumab)
- Group 2: Arm I (chemotherapy)
- 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.
- 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
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)."
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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