Olaparib In Metastatic Breast Cancer

Conditions

• ATM Gene Mutation
• BRIP1 Gene Mutation
• CHEK2 Gene Mutation
• Invasive Breast Cancer
• Metastatic Breast Cancer
• NBN Gene Mutation
• PALB2 Gene Mutation
• RAD51 Gene Mutation
• Somatic Mutation Breast Cancer (BRCA1)
• Somatic Mutation Breast Cancer (BRCA2)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olaparib — DRUG
  olaparib tablets bid daily continuously on a 21 day cycle until progression, intolerable toxicity, consent withdrawn, patient noncompliance or death.

Study Details

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.

Key Dates

Start date

Apr 1, 2018

Status verified

Dec 2025

Primary completion

Jul 30, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

114 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: OLAPARIB QD GERMLINE MUTATION
  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
• Experimental: OLAPARIB QD GERMLINE MUTATION - EXPANSION
  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
• Experimental: OLAPARIB QD SOMATIC MUTATION
  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
• Experimental: OLAPARIB QD SOMATIC MUTATION - EXPANSION
  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

Primary Outcome Measure

Objective Response Rate [ Time Frame: 21 Days ]

Locations (20)

Find similar trials in Birmingham, AL

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