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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
This study will examine how Olaparib in combination with the drugs Cediranib or Ceralasertib works for patients with advanced breast cancer who have 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, [email protected], 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 advanced or breast cancer, have a or genetic mutation and were previously treated with a . The study will examine how effective  in combination with Cediranib or Ceralasertib is in reducing the size of cancer and determining 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

This Study is Open To:

Assigned female at birth aged 18 years and older, who meet the following criteria:

All groups

  • Give informed consent
  • Have advanced or breast cancer with negative and a or mutation. People with receptor positive (ER+) breast cancer must have disease progression after previous endocrine therapy or these treatments are inappropriate.
  • Have a life expectancy of more than 16 weeks
  • Have a negative pregnancy test prior to study treatment and during study
  • Use contraception 30 days prior to first treatment, for duration of the treatment, and at least 1 month after finishing the trial treatment
  • Are willing to follow study schedule and instructions
  • Have measurable diseases that can be detected with a CT or scan
  • Willing to undergo a biopsy of the lesion before starting trial treatment
  • Willing to provide blood samples before starting treatment and at the end of the study
  • Have been treated with any for at least 4 months
  • Able to swallow oral medication
  • 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.
This Study is Not Open To:

People under 18 years old and who:

  • Had chemotherapy or radiation therapy within 3 weeks prior to start the study treatment
  • Had severe side effects from previous treatment
  • Have not recovered from side effects of treatments that they received more than 3 weeks
  • Receive any other investigational treatment within the past 4 weeks
  • Have untreated brain metastases, symptoms of brain metastases, or spinal cord compression
  • Have received prior inhibitor of VEGF signaling
  • Have history of allergic reactions to the ingredients of or Cediranib or Ceralasertib
  • 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 including lung disease, active infection or a severe mental illness that would limit the ability to participate in the study
  • Have heart disease that requiring treatment
  • Have history of myocardial infarction or stroke within 6 to 12 months and currently require medications
  • Have history of hypertensive crisis or hypertensive encephalopathy, cause brain damages due to elevated blood pressure, within 3 years
  • Have vascular diseases including abdominal aortic aneurysms
  • Undergone surgery, open biopsy, or injury within 28 days prior to starting Cediranib
  • 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 an infection in the stomach, within the 3 months prior to study enrollment
  • Need intravenous (IV) fluids or total parenteral nutrition
  • Have myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) 
  • Have uncontrolled diseases, active bleeding diseases, or kidney transplant
  • Have infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  • Have had previous treatment with Ceralasertib and Cediranib
  • Have uncontrolled seizures
  • Have arrhythmia
  • Have hypotension (< 100/60 mm Hg) or uncontrolled hypertension that require treatment
  • Women who are pregnant or are breast feeding
  • Have prior bone marrow transplant
  • Have progression disease within 1 months after finishing platinum-based chemotherapy
  • Have surgery within 3 weeks of study treatment
  • (Group1) Have a bleeding disease
  • (Group2) diagnosis with ataxia telangiectasia (Louis-Bar syndrome)