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Carboplatin vs. Carboplatin + Everolimus for Advanced Breast Cancer
Study Summary
This trial will compare the safety and effectiveness of carboplatin to a combination of carboplatin and everolimus for the treatment of advanced TNBC.
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 2022 Phase 3 trial • 1301 Patients • NCT03038100Trial Design
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Who is running the clinical trial?
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- I haven't had any cancer in the past 3 years, except for treated skin cancer or cervical cancer.I am a woman with breast cancer that has spread, including to bones.I have had up to 3 treatments for my cancer after it spread.I haven't had any cancer treatments in the last 2 weeks.I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery soon.I have brain metastases that are not under control.I am not taking strong medication inhibitors like ketoconazole.I've been on a stable dose of low-dose steroids or no immunosuppressants for over 4 weeks.I have not had any live vaccines in the last week and will avoid close contact with those who have.My kidney function is normal, with creatinine levels within the acceptable range.My cancer has spread to the lining of my brain and spinal cord.I do not have severe health issues that could affect my study participation.My breast cancer is triple negative.I am 18 years old or older.I have had up to 3 treatments for my cancer after it spread.My brain metastases have been stable for over 2 weeks after treatment, and I am not on steroids.You need to have a CT scan of your chest, abdomen, and pelvis, and a bone scan or PET/CT before joining the study.You need to have a negative pregnancy test no more than 7 days before starting treatment.It's been over a year since my last carboplatin treatment.My liver tests are within the required range.I can perform light activities but not work.My blood tests show normal white blood cells, platelets, and hemoglobin levels.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.
- Group 1: Carboplatin alone
- Group 2: Carboplatin + Everolimus
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 has Carboplatin shown to be most effective in treating?
"While often used to treat advanced sarcoma, carboplatin can also be an effective way of managing refractory advanced renal cell carcinoma, initial treatment, and advanced thymoma."
Are new participants being signed up for this experiment at this time?
"This study, as reflected on clinicaltrials.gov, is still recruiting patients for the trial. The first posting was on August 1st, 2015 with the most recent edit being on October 22nd, 2021."
Are there any known risks associated with Carboplatin?
"There is some data indicating that Carboplatin is safe, but none yet supporting that it is effective. We rated it a 2."
How many volunteers are helping to test this new medication?
"That is correct. Based on the information available from clinicaltrials.gov, it appears that this research project is still recruiting patients. The trial was first posted on 8/1/2015, and the most recent update was on 10/22/2021. They are looking for a total of 72 participants who will be located at 3 different sites."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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