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Trial Title:
Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer
NCT ID:
NCT05522491
Condition:
Solid Tumor
Conditions: Official terms:
Triple Negative Breast Neoplasms
Olaparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olaparib
Description:
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.
Arm group label:
Olapalib
Summary:
This is an open-label, single-arm, single-center,exploratory clinical study.
Detailed description:
This is an open-label, single-arm, single-center,exploratory clinical study initiated by
the investigator to evaluate the efficacy of olaparib in recurrent and metastatic TNBC
without BRCA1/2 mutation and methylated BRCA1 promoter.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age 18-70 years old, female; 2. Histologically confirmed recurrent and
metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter
methylation.
Note: Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone
receptor (PR), and human epidermal growth factor receptor (HER2) negative. ER and PR
negative were defined as: ER<1% positive, PR<1% positive. HER2 negativity was defined as:
HER2 (-) or (1+) or HER2 (2+) FISH negative by immunohistochemistry.
3. The number of treatment lines at the stage of recurrence and metastasis should not
exceed 2 lines.
4. According to RECIST1.1 criteria, there is at least one evaluable lesion; 5. ECOG
physical condition score ≤ 1 point; 6. Expected survival period ≥ 3 months;
Exclusion Criteria:
-
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 1, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522491
