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Pertuzumab + Trastuzumab + Chemotherapy for Advanced Breast Cancer
Study Summary
This trial is testing pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation to see how well it works in treating HER2-positive stage II-IV breast cancer.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 1095 Patients • NCT01120184Trial Design
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- You have not received chemotherapy or trastuzumab for metastatic breast cancer treatment before.If you have metastatic breast cancer, you can participate if you had chemotherapy and trastuzumab more than 12 months ago.Your white blood cell count is at least 3.0 billion cells per liter.You have active hepatitis B or C.You have nerve problems worse than mild.Your heart's pumping ability was less than 50% during previous treatment with trastuzumab.You are able to carry out your normal activities without restrictions or with only a little restriction due to your medical condition.You currently have active HIV.You need to have a certain level of a type of white blood cells called neutrophils in your blood.You don't have any other cancer that is currently growing, except for non-melanoma skin cancer. If you finished treatment for another cancer and have a low chance of it coming back, you can still join the study.You have cancer that has spread to your brain or spinal cord.You have advanced breast cancer that has spread to other parts of your body, or you have a specific type of breast cancer called HER2 over-expression.You have been treated for breast cancer or any other invasive cancer within the last 5 years.Your liver enzymes (AST and ALT) are not more than two times the normal limit.You have not received any treatment for your metastatic breast cancer except for anti-estrogen therapy. If you had chemotherapy for breast cancer in the past, it should have been at least 12 months ago. If you had a different type of cancer more than 5 years ago, you can still participate as long as you have not been treated with nab-paclitaxel before.Your platelet count is at least 100 billion per liter.Your hemoglobin level is at least 9 grams per deciliter.Women who could become pregnant must have a negative pregnancy test.You have received a high dose of doxorubicin or a similar drug as part of previous treatment.You have had a different type of cancer, except for basal cell skin cancer.Your tumor shows specific levels of hormone receptors and HER2 expression, as determined by lab tests.Your total bilirubin level should be no higher than 1.3 mg/dl, which is the normal level in the hospital where the study is taking place.Your kidney function is within the normal range.Your heart is pumping blood normally, as shown by a recent heart test.
- Group 1: Treatment (pertuzumab, trastuzumab, nab-paclitaxel)
- 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
Can people with the qualifying medical condition enroll in this trial right now?
"Currently, this clinical trial is not enrolling patients. The study was first posted on 7/17/2013 and updated as recently as 3/17/2022. However, there are 2389 other trials for erbb-2 receptor and 1053 studies for pertuzumab that are admitting patients."
How many individuals are allowed to be a part of this experimental process?
"At this moment, this clinical trial is not looking for any more enrolments. The original posting was on July 17th, 2013 and the most recent update was March 17th, 2022. If you are interested in other trials, there are 2389 active studies involving the erbb-2 receptor and 1053 pertuzumab trials currently underway."
What is the primary indication for pertuzumab?
"Pertuzumab can be used to treat various conditions, such as locally advanced non-small cell lung cancer, metastatic bladder cancer, and mediastinitis."
With pertuzumab trials, what other cancer treatments have been explored?
"Pertuzumab has 1053 ongoing clinical trials with 271 in Phase 3. Some of these pertuzumab trials are based in Seattle, Washington while there are 55200 total locations running clinical trials for pertuzumab."
Has pertuzumab received the green light from the FDA?
"Pertuzumab has received a score of 2, meaning that while there is some data supporting its safety, there are no studies indicating whether or not it is an effective treatment."
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