Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer

ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHebei Medical University Fourth Hospital

About this trial

This is an open-label, single-arm, single-center,exploratory clinical study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 18-70 years old, female; 2. Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation.

Disqualifiers

1. Pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures; 2. Patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment; 3. Previous use of PARP inhibitors, including olaparib and other PARP inhibitors; 4. Known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, QT interval>450ms; 5. The toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia); 6. Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy; 7. Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases; 8. History of severe central nervous system disease (including epilepsy patients); 9. In the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment; 10. Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections; 11. Patients who are allergic to this test drug or similar drugs; 12. Those who have participated in clinical trials of other drugs within 28 days before screening, or plan to participate in any other clinical trials during this study; 13. Any other disease or condition of clinical significance (such as active or uncontrolled infection, etc.) that the investigator believes may affect compliance with the protocol or affect the patient's signing of ICF

Trial design

Design model

Single group

Treatments tested in this trial

  • Olaparib

    Drug

    All subjects enrolled will receive olaparib.Subjects continued to take medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or discontinuation of medication at the discretion of the investigator.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: OlapalibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR ORR

Objective response rate

Time frame
24 month

Secondary outcomes

1

PFS

Progression-free survival

Time frame
24 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: