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Olaparib + Cediranib/Ceralasertib for Advanced Breast Cancer
Study Summary
This trial studies olaparib with cediranib or AZD6738 as a treatment for patients with BRCA mutated breast cancer that has spread to other places in the body.
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 2023 Phase 3 trial • 154 Patients • NCT02184195Trial Design
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Who is running the clinical trial?
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- I haven't had symptoms of bowel blockage in the last 3 months.I do not have any bleeding disorders.I have taken a pregnancy test that was negative before starting the study treatment.I am not pregnant and use effective birth control or cannot become pregnant.I have had a bone marrow or double cord blood transplant.My kidney function is good, based on tests.My heart health meets the study's requirements.My liver function tests are within normal limits, unless I have liver metastases.I cannot swallow pills or have stomach issues affecting medication absorption.I have serious blood vessel problems.I do not have ataxia telangiectasia.I have seizures that are not controlled by medication.I am fully active or can carry out light work.I have previously been treated with AZD 6738 and cediranib.You have a hole in a specific area of your lung.I am currently using herbal products or alternative medicines.My tests may show signs of MDS or AML.Your bilirubin levels must be within a certain range as determined by the hospital.Your platelet count is at least 100 billion per liter.I had major surgery over 3 weeks ago and have recovered from it.I have not had major surgery or significant injury within the last 28 days.I was treated with a PARP inhibitor for 4 months or more before my disease progressed.The amount of protein in your urine is very low.I am receiving treatment for congestive heart failure.I am willing and able to follow the study's treatment plan and attend all visits.My white blood cell count is healthy without recent medication to boost it.My thyroid function is normal, with no symptoms of issues.I have not had significant bleeding or coughed up blood in the last month.I had a heart attack, stroke, or mini-stroke in the last 6 to 12 months.I haven't had chemotherapy or radiation in the last 3 weeks and have no major side effects from past cancer treatments.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.My cancer returned or worsened within 1 month after finishing platinum-based chemotherapy for advanced cancer.I am not taking any strong medication that affects liver enzymes.I have brain metastases or spinal issues related to my cancer that haven't been treated.I am allergic to medications similar to cediranib, olaparib, or AZD6738.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You have a tumor that can be measured using specific guidelines.I have previously been treated with a VEGF inhibitor.I do not have severe diseases, uncontrolled bleeding, kidney transplant, or active infections like hepatitis or HIV.I have not had an abdominal abscess in the last 3 months.I can take pills and don’t have stomach issues affecting medicine absorption.I am willing to have a biopsy of my cancer that has spread.My breast cancer is advanced, HER2 negative, BRCA positive, and has not responded to hormone therapy.I have not had any other cancer besides this one in the last 5 years.My blood pressure is under control with up to 3 medications.
- Group 1: Arm II (olaparib plus ceralasertib)
- Group 2: Arm I (olaparib plus cediranib)
- 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
Are more participants needed for this experiment at the present time?
"Indeed, clinicaltrials.gov reveals that this medical experiment is actively accepting participants. It was initially posted on July 28th 2020 and updated as recently as March 31st 2022. Approximately 60 individuals are expected to be recruited from a single site."
What is the current capacity for enrolment in this research project?
"Indeed, the clinical trial data present on clinicialtrials.gov confirms that recruitment for this study is still ongoing. It was initially posted on July 28th 2020 and most recently updated in March 31st 2022, with a need to recruit 60 patients from 1 medical centre."
To what degree can Olaparib be considered a risk to human health?
"As this is a second-phase trial, there's evidence of Olaparib's safety making its score 2 out of 3. However, no data exists to support the drug's efficacy yet."
Could you elaborate on any additional research done with Olaparib?
"Olaparib is the subject of 204 active research trials, 27 which are in their final phase. While Houston, Texas houses many studies for this drug, there are over 9 thousand other locations running clinical trials on its efficacy."
Is this experiment the inaugural endeavor of its kind?
"Globally, there are 204 dynamic clinical trials involving the drug Olaparib being conducted across 59 countries and 1490 cities. The original trial for this medication began in 2005 when 98 participants took part in a Phase 1 Drug Approval study sponsored by AstraZeneca. Since then, 113 studies have been concluded."
What ailments is Olaparib typically prescribed to treat?
"Olaparib is a medication that can be prescribed to treat numerous conditions, ranging from advanced directives to malignant neoplasm of ovary and primary peritoneal cancer. It may also be administered for hallucinations and somatic problems."
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