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Chemotherapy for Advanced Breast Cancer
Study Summary
This trial looks at the side effects of a chemotherapy drug in treating older patients with 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.Side effects data
From 2016 Phase 3 trial • 50 Patients • NCT02019277Trial Design
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Who is running the clinical trial?
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- I am receiving my first or second round of chemotherapy for cancer that has spread.I am allergic to paclitaxel.I have brain metastases that haven't been treated or need more steroids to manage symptoms.Your platelet count is at least 100,000 cells per cubic millimeter.My alkaline phosphatase levels are normal or slightly elevated, and I don't have liver metastases.I have recovered from serious side effects of my previous treatment, except for hair loss.My kidneys are functioning well enough (creatinine clearance >= 30 ml/min).I have received taxane treatment in the past year.You have enough infection-fighting white blood cells in your body.Your hemoglobin level is at least 9.0 grams per deciliter.Your bilirubin level must be 1.5 mg/dl or lower.My nerve damage symptoms are mild or not present.Your AST and ALT levels are not more than 2.5 times the normal limit at the study site.I am able to care for myself but may not be able to do active work.I do not have any serious or uncontrolled infections.My breast cancer can be any type, but I will be treated with nab-paclitaxel only.My breast cancer has spread beyond the original site.
- Group 1: Treatment (nab-paclitaxel)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
Is there an enrollment window still open for this clinical trial?
"Per the information posted to clinicaltrials.gov, this particular medical trial is not actively recruiting participants at present. This study first launched on June 19th 2012 and was last updated on June 30th 2022 however there are currently 5414 different trials open for enrollment across the United States of America."
Has Nab-paclitaxel clearance been granted by the Food and Drug Administration?
"Our experts at Power gave nab-paclitaxel a rating of 2 due to the fact that there is some evidence supporting its safety, but not much regarding efficacy as this treatment is still in Phase 2 trials."
How many participants are being recruited for the research project?
"Unfortunately, this particular medical trial is no longer accepting patients. It was first made available on June 19th 2012 and the last update occurred on June 30th 2022. However, there are still 4558 trials for breast cancer and 856 studies involving Nab-paclitaxel that are open to participants."
What therapeutic effects is this investigation expected to yield?
"According to the given trial, ascertainment of primary outcome will be conducted over a 30-month time period and it is focused on evaluating Degree Reduction Rates. Secondary outcomes include Cancer Specific Geriatric (CARG) Assessment which assesses functional status, co-morbidity, cognition capacity, psychological health, social functioning/support and nutrition levels; Time to Progression calculated via Kaplan Meier product limit method; Response Determined by Response Evaluation Criteria in Solid Tumors utilizing rates with 95% exact Clopper & Pearson binomial confidence limits for Objective Response Rate (Complete Response [CR] + Partial Response [PR])."
Have there been any preceding experiments involving Nab-paclitaxel?
"Nab-paclitaxel was first experimented with in 1997 at the City of Hope Comprehensive Cancer Center. As of today, there have been 1921 trials that have concluded and 856 studies are still ongoing; many located within South Pasadena, Ohio."
To what therapeutic purpose is Nab-paclitaxel most commonly employed?
"Nab-paclitaxel is primarily used to treat hypoalbuminemia, but can also be effective in patients suffering from acute pyelonephritis (APN), shock, hypovolemic and non-small cell lung cancer."
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