Olaparib with Cediranib or Ceralasertib for People with Advanced or Metastatic Breast Cancer and with a BRCA1 or BRCA2 Mutation
Clinicaltrials.gov identifier:
NCT04090567
Treatment
Treatment study for people with advanced breast cancer who have a BRCA1 or BRCA2 genetic mutation and who were previously treated with a PARP inhibitor
Study Contact Information:
For additional information, please contact:
Principal Investigator: Banu Arun, barun@mdanderson.org, 713-792-2817
Olaparib with Cediranib or Ceralasertib for People with Advanced or Metastatic Breast Cancer and with a BRCA1 or BRCA2 Mutation
About the Study
This study is for people with a or genetic mutation, with , breast cancer who were previously treated with a . The study will look at how well the drug works when combined with either cediranib or ceralasertib in reducing the size of cancer and expanding the length of time patients respond well to the treatment.
What the Study Involves
Participants are assigned to one of two groups in this study. They are followed for 30 days after completion of study treatment.
Group1
Participants will take orally twice a day and cediranib orally once a day on day 1 to day 28. They will continue with the cycles until the treatment stops working or causes serious side effects.
Group2
Participants will take orally twice a day on day 1 to day 28 and Ceralasertib orally once a day on day 1 to day 7. They will continue with cycles until the treatment stops working or causes serious side effects.
Study Site
Texas
MD Anderson Cancer Center
Houston, Texas 77030
Assigned female at birth aged 18 years and older, who meet the following criteria:
All groups
- Have advanced or breast cancer that is negative with a or mutation. People with receptor positive (ER+) breast cancer must have disease progression after previous hormone therapy.
- Have a life expectancy of more than 16 weeks.
- Have a negative pregnancy test prior to study treatment and during study.
- Have measurable diseases that can be detected with a CT or scan.
- Are willing to have a biopsy of the lesion before starting trial treatment.
- Have been treated with any for at least 4 months.
- Do not have gastrointestinal illnesses that interfere with the absorption of medications.
- Have adequate kidney and thyroid function.
Group1
- Have adequate blood pressure (systolic blood pressure [SBP] =< 140 mmHg; diastolic blood pressure [DBP] =< 90 mmHg) that is checked within 2 weeks prior to the trial study and on maximum of 3 antihypertensive medications.
People any of the following cannot participate:
- Had surgery, chemotherapy or radiation therapy within 3 weeks prior to start the study treatment.
- Had severe side effects from previous treatment or have not recovered from side effects of previous treatments.
- Received any other investigational treatment within the past 4 weeks.
- Have untreated brain metastases, symptoms of brain metastases, or spinal cord compression.
- Have received prior treatment with a drug known as a VEGF inhibitor.
- Use complementary alternative medications including natural herbal products within 7 days prior to study treatment.
- Have other invasive cancers within the past 5 years except skin cancer, breast cancer and cervix cancer on early stages.
- Have other uncontrolled illness.
- Have bowel obstruction, something blocks your intestines and causes pain and discomfort, within 3 months before the study treatment.
- Have significant bleeding within the last 1 month prior to study enrollment.
- Have myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML).
- Have infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Are pregnant or are breast feeding.
- Have prior bone marrow transplant.
- Have progression disease within 1 months after finishing platinum-based chemotherapy
- (Group1) Have a bleeding disease.
- (Group2) diagnosis with ataxia telangiectasia (Louis-Bar syndrome).