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This is an open-label, single-arm, single-center,exploratory clinical study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olapalib | Experimental | Olaparib Oral 300mg 2/day; 4 weeks (28 days) as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR ORR | Objective response rate | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | 24 month |
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Inclusion Criteria:
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:
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| ID | Term |
|---|---|
| C531550 | olaparib |
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