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Association details:
Biomarker:PALB2 mutation
Cancer:Breast Cancer
Drug:Lynparza (olaparib) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Predicting olaparib sensitivity in metastatic HER2-negative breast cancer with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutation or RAD51-negative test Predicción de la sensibilidad a Olaparib en pacientes con cáncer de mama HER2 negativo localmente avanzado irresecable o metastásico con mutaciones en BRCA1, BRCA2, PALB2, RAD51C o RAD51D o con niveles bajos RAD51

Excerpt:
...Los pacientes deben ser hombres o mujeres de ≥18 años 3.Los pacientes deben de tener la capacidad de proporcionar un formulario de consentimiento informado por escrito firmado y fechado antes de cualquier procedimiento, muestreo y análisis.4.Cáncer de mama confirmado histológica o citológicamente con evidencia de enfermedad localmente avanzada5.Los pacientes pueden tener cáncer de mama triple negativo y HER2 negativo o cáncer de mama ER / PgR positivo, siempre que sean HER2 negativo y coherentes con los estándares locales y las pautas más recientes de ASCO CAP Cohorte 1: Mutación en BRCA1, BRCA2, PALB2, RAD51C o RAD51D 6.Pacientes que hayan recibido platino y no haya habido evidencia de progresión de la enfermedad durante la quimioterapia.7.Pacientes que hayan recibido platino y / o inhibidores de PARP y que hayan transcurrido al menos 6 meses entre la última dosis de PARP. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

Olaparib In Metastatic Breast Cancer

Excerpt:
...- Cohort 1a: germline PALB2 mutation -- The mutation must be identified through a CLIA-approved NGS panel....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.

Excerpt:
...Cohort 1: Documented germline or somatic mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

88P - Efficacy of olaparib in advanced cancers occurring in patients with germline or somatic tumor mutations in homologous recombination (HR) genes, a Belgian Precision phase II basket study

Published date:
09/13/2021
Excerpt:
One complete response was observed in a stage IV breast cancer that harbours a PALB2 germline mutation....Treatment with olaparib shows activity in cancer pts with a HR gene mutation and is well tolerated.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).

Published date:
05/13/2020
Excerpt:
Patients received olaparib 300 mg...Responses were gene specific (Table): gPALB2 and sBRCA mutations predicted response…
DOI:
10.1200/JCO.2020.38.15_suppl.1002
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes

Excerpt:
Patients received olaparib 300 mg orally twice a day until progression….In cohort 1, ORR was 33% (90% CI, 19% to 51%) and in cohort 2, 31% (90% CI, 15% to 49%). Confirmed responses were seen only with gPALB2 (ORR, 82%) and sBRCA1/2 (ORR, 50%) mutations....PARP inhibition is an effective treatment for patients with MBC and gPALB2 or sBRCA1/2 mutations, significantly expanding the population of patients with breast cancer likely to benefit from PARPi beyond gBRCA1/2 mutation carriers.
DOI:
10.1200/JCO.20.02151
Trial ID: