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Chemotherapy +/− Trastuzumab for Breast Cancer
Study Summary
This trial is testing paclitaxel and cyclophosphamide with or without trastuzumab before surgery to see if it can reduce the amount of normal tissue that needs to be removed in patients with previously untreated 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 do not have any unmanaged ongoing illnesses.I have had cancer before, but it was either skin cancer treated successfully or a non-spreading type that was treated.I haven't had a heart attack in the last 6 months and don't have severe heart issues.You have at least one spot that can be measured using a mammogram, ultrasound, or MRI.Your alkaline phosphatase level is not more than 1.5 times the normal limit.I am a woman with breast cancer that has not spread far and my tumor is at least 1 cm big.Your platelet count is at least 150,000 per microliter.I understand my cancer diagnosis and have given written consent for treatment.I am a woman who can have children and have a recent negative pregnancy test.I cannot have surgery.I am unable to follow the treatment plan as required.I have HIV, hepatitis, or liver problems.I am fully active or restricted in physically strenuous activity but can do light work.Your absolute neutrophil count is at least 1,500 per microliter.My breast cancer is inflammatory, stage IV, or has spread to other parts.Your total bilirubin level in the blood is no more than 1.5 times the upper limit of normal.I have moderate numbness, pain, or tingling in my hands or feet.My heart pumps well and has normal movement.Your liver enzyme levels (AST and ALT) are not more than 1.5 times the upper limit of normal.I have had chemotherapy or hormone therapy for breast cancer or another type of cancer.Your kidney function, measured by creatinine, is within a certain normal range.I had radiation over 5 years ago for cancer other than breast cancer and have no signs of another cancer now.
- Group 1: Treatment (chemotherapy, surgery, post-operative therapy)
- 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
Has the Food and Drug Administration approved Trastuzumab for medicinal use?
"While there is evidence of trastuzumab's safety, no clinical trials have proven its efficacy. Thus it has been rated 2 out of 3 on the Power team's scale."
Is this experiment the first of its kind to be conducted?
"Alfacell spearheaded the inaugural Trastuzumab trial in 1997, with 300 participants. Following its success and subsequent Phase 3 approval, 1824 active studies have been launched around the world; spanning 82 countries across 3702 cities."
What ailments is Trastuzumab typically prescribed for?
"The pharmaceutical agent cyclophosphamide is often combined with the medication trastuzumab for therapeutic purposes. Additionally, this drug can be beneficial in treating Kaposi's sarcoma AIDS related, leukemia, and non-small cell lung cancer that has spread around a localized area."
How many individuals are engaging in this research experiment?
"Unfortunately, this clinical trial is not currently enrolling patients. It was initially posted on the 1st of December 2012 and last updated 3rd March 2022. However, if you are looking for other studies there are a total of 4562 trials actively recruiting individuals with her2/neu negative status as well as 1824 trials that have Trastuzumab interventions available."
Has recruitment for this clinical experiment been closed off to participants?
"It appears that the clinical trial referenced is not currently recruiting, as it was last modified on March 3rd 2022. However, 6386 other studies are actively searching for participants at this time."
What other research investigations have been executed related to Trastuzumab?
"Trastuzumab is the subject of 1824 active clinical trials, with 408 studies in Phase 3. Seattle, Washington alone has several investigations going on for Trastuzumab while 77013 sites are testing this medication globally."
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