CHEK2 Mutation > Olaparib

Olaparib for Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen By Nadine Tung, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is for patients with metastatic breast cancer. * Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. * This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. * Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. * This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. * This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited.

Eligibility Criteria

This trial is for adults with metastatic breast cancer that has spread beyond the breast and have specific gene mutations (excluding BRCA1/2). Participants must have normal organ/bone marrow function, no more than two prior chemotherapy regimens for metastasis, not be pregnant or breastfeeding, able to take oral medication, and willing to follow study procedures.

Inclusion Criteria

My breast cancer is at stage IV and has been confirmed by tests.

I have a genetic mutation in a DNA repair gene, but not in BRCA1 or BRCA2.

I have not failed more than two chemotherapy treatments for my advanced cancer.

I have received specific previous treatments for my cancer, including chemotherapy.

I have a tumor that can be measured and monitored over time.

Exclusion Criteria

I have not had major surgery in the last 2 weeks.

I am not taking strong or moderate drugs that affect liver enzyme activity.

I have lasting side effects from cancer treatment, but not hair loss.

I have a BRCA1 or BRCA2 gene mutation.

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.

I have never been treated with a PARP inhibitor like olaparib.

I have brain metastases that are not under control and cause symptoms.

I have had a bone marrow or cord blood transplant in the past.

I cannot take pills by mouth or have stomach issues that affect medication absorption.

I do not have active hepatitis B or C.

Participant Groups

The trial tests Olaparib's effectiveness in patients whose tumors are sensitive due to certain genetic mutations. Olaparib is a PARP inhibitor which may help treat cancer by exploiting the tumor's impaired DNA repair ability. The study includes those with inherited or tumor-only mutations.

Group I: OLAPARIB QD SOMATIC MUTATION - EXPANSION Experimental Treatment 1 Intervention

After the screening procedures confirm eligibility to participate in the research study: * Olaparib: Each study treatment cycle lasts 21 days (3 weeks), taking 2 times per day, 12 hours apart. * Tumor measurements q6 weeks x 24 weeks, then q 12 weeks

Group II: OLAPARIB QD SOMATIC MUTATION Experimental Treatment 1 Intervention

After the screening procedures confirm eligibility to participate in the research study: * Olaparib: Each study treatment cycle lasts 21 days (3 weeks), taking 2 times per day, 12 hours apart. * Tumor measurements q6 weeks x 24 weeks, then q 12 weeks

Group III: OLAPARIB QD GERMLINE MUTATION - EXPANSION Experimental Treatment 1 Intervention

After the screening procedures confirm eligibility to participate in the research study: * Olaparib: Each study treatment cycle lasts 21 days (3 weeks), taking 2 times per day, 12 hours apart. * Tumor measurement q6 weeks x 24 weeks, then q 12 weeks

Group IV: OLAPARIB QD GERMLINE MUTATION Experimental Treatment 1 Intervention

After the screening procedures confirm eligibility to participate in the research study: * Olaparib: Each study treatment cycle lasts 21 days (3 weeks), taking 2 times per day, 12 hours apart. * Tumor measurement q6 weeks x 24 weeks, then q 12 weeks

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

🇺🇸 Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center Bergen Montvale, NJ

Duke University Durham, NC

University of Washington Seattle Cancer Care Alliance Seattle, WA

Johns Hopkins University Baltimore, MD

More Trial Locations

Who is running the clinical trial?

Beth Israel Deaconess Medical Center Lead Sponsor

Johns Hopkins University Collaborator

AstraZeneca Industry Sponsor

Dana-Farber Cancer Institute Collaborator

References