Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study
To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC...
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| Published in: | Breast (Edinburgh) Vol. 78; p. 103834 |
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| Abstract | To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut).
NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.
Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8–88.2).
The observed results could prompt further investigation.
ClinicalTrials.gov identifier NCT03367689.
•TNBC is a heterogenous disease with poor prognosis and limited therapeutic options.•Olaparib was approved for HER2-negative advanced BC patients with gBRCA1/2mut.•Out of 114 patients screened, only 6 were eligible and received olaparib.•Olaparib showed 50 % of CBR and ORR in advanced TNBC patients with HRD and without gBRCA1/2mut.•The patient population was low, and the results warrant further investigation in larger trials. |
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| AbstractList | To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut).PURPOSETo evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut).NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.METHODSNOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8-88.2).RESULTSSix of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8-88.2).The observed results could prompt further investigation.CONCLUSIONSThe observed results could prompt further investigation.ClinicalTrials.gov identifier NCT03367689.TRIALClinicalTrials.gov identifier NCT03367689. To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1. Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8–88.2). The observed results could prompt further investigation. ClinicalTrials.gov identifier NCT03367689. •TNBC is a heterogenous disease with poor prognosis and limited therapeutic options.•Olaparib was approved for HER2-negative advanced BC patients with gBRCA1/2mut.•Out of 114 patients screened, only 6 were eligible and received olaparib.•Olaparib showed 50 % of CBR and ORR in advanced TNBC patients with HRD and without gBRCA1/2mut.•The patient population was low, and the results warrant further investigation in larger trials. • TNBC is a heterogenous disease with poor prognosis and limited therapeutic options. • Olaparib was approved for HER2-negative advanced BC patients with g BRCA1/2 mut. • Out of 114 patients screened, only 6 were eligible and received olaparib. • Olaparib showed 50 % of CBR and ORR in advanced TNBC patients with HRD and without gBRCA1/2mut . • The patient population was low, and the results warrant further investigation in larger trials. Purpose: To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). Methods: NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1. Results: Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8–88.2). Conclusions: The observed results could prompt further investigation. Trial: ClinicalTrials.gov identifier NCT03367689. |
| ArticleNumber | 103834 |
| Author | Cortés, Alfonso Gener, Petra Mina, Leonardo Rodríguez-Morató, Jose Carañana, Vicente Antonarelli, Gabriele Urruticoechea, Ander Servitja, Sonia Lema-Roso, Laura Fernández-Ortega, Adela Márquez, Antonia Pérez-García, José Lazaris, Alexandros Llombart-Cussac, Antonio Alcalá-López, Daniel López-Miranda, Elena Cortés, Javier |
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| Keywords | Olaparib Germline BRCA1/2 mutations Homologous recombination deficiency PARP inhibitors Triple-negative breast cancer |
| Language | English |
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fullname: Tung |
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| Snippet | To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations... • TNBC is a heterogenous disease with poor prognosis and limited therapeutic options. • Olaparib was approved for HER2-negative advanced BC patients with g... Purpose: To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2... |
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| SubjectTerms | Germline BRCA1/2 mutations Homologous recombination deficiency Olaparib PARP inhibitors Short Communication Triple-negative breast cancer |
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| Title | Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study |
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