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Association details:
Biomarker:BRCA2 mutation
Cancer:Solid Tumor
Drug:Lynparza (olaparib) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Pancreatic Cancer)
New
Title:

Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers

Excerpt:
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers….The three approvals authorise Lynparza for:...maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

Excerpt:
...Germline and somatic BRCA status (genetic testing) are planned for future correlative evaluation, in order to examine treatment and circulating tumor deoxyribonucleic acid (ctDNA) response as stratified by BRCA 1/2 mutational status....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

Excerpt:
...- All participants must have documented BRCA 1/2 mutant or other HRD+ in solid tumor, which is identified through a validated sequencing test...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation

Excerpt:
...- Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Excerpt:
...- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib In Metastatic Breast Cancer

Excerpt:
...- Documented somatic mutation (deleterious or suspected deleterious) in BRCA1 or BRCA2 through any CLIA approved lab only if in addition to the lack of a germline BRCA1/2 mutation is demonstrated through a CLIA approved lab....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)

Excerpt:
...- For participants who have non-breast or -ovarian cancers that are breast cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are BRCA1/2 non-mutated and homologous recombination repair nonmutated:...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Excerpt:
...- Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Excerpt:
...- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Excerpt:
...Difference in levels of PAR or PARP-1 before and after study treatment`Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Excerpt:
...- Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

Excerpt:
...somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A] or germline mutations in the above genes....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer

Excerpt:
...Absence of deleterious or suspected deleterious germline mutations in BRCA1 and BRCA2....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

Excerpt:
...- Documented gBRCA1/2 mutation status...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

Excerpt:
...Progression-free survival (PFS) and Overall survival (OS) will be evaluated according to biomarkers ((i.e., PD-L1, ERCC1, SLFN11, STK11, KEAP1, p53 expression, DNA repair genes [including BRCA 1-2 mutations] and tumor mutational burden)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer

Excerpt:
...Documented germline or somatic mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) [Genetic counselling for patients with germline BRCA mutations should be performed according to local regulations] Or Tumour BRCAwt status and documented qualifying mutation in any of 13 genes involved in the HRR pathway, excluding BRCA1 and BRCA2 (ATM, BARD1, BRIP1,CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D,and RAD54L), identified by the Lynparza HRR Assay in archival tumour tissue (i.e.,BRCA-independent HRRm) 4....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

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

Excerpt:
...Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Functional Analysis of BRCAness

Excerpt:
...time from start of maintenance olaparib to the date of first documented disease progression or death from any cause, whichever occurs first, of olaparib for the BRCA1 or BRCA2 mutant (germline or somatic) HR deficient group, the non BRCA mutant HR deficient group and the HR proficient group`time from start olaparib to death (any cause).`...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations

Excerpt:
...1) BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B, RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency

Excerpt:
...Assess the efficacy of olaparib in HER2-negative early Breast Cancer and HRD (BRCA 1/2 mutations and/or HRD positive). ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers

Excerpt:
...Men with BRCA1/2 mutation and metastatic breast cancer will be eligible for study....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

nd nd

Excerpt:
...Documented mutation in BRCA1 or BRCA2 germline and/or somatic that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function);4. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A study, performed in several centers, to examine the treatment of Olaparib at the time of disease progression in ovarian, peritoneal or fallopian tube cancer before an operation.

Excerpt:
...• Biological effects in the primary tumour following a short pre-operative course of treatment with Olaparib in patients with platinum sensitive relapsed ovarian cancer; the biological effects are assess in terms of the degree of PAR or PARP-1 inhibition (in tissue and ctDNA) • Germline HRD mutations and tissue mutation with respect to BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 (in tissue and ctDNA)• Generate initial clinical efficacy data for future studies (RECIST 1.1)...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ANZ 1103 Study of Olaparib Clinical Effect in Patients with Breast Cancer or Ovarian Cancer

Excerpt:
...b) Male or female with histologically confirmed, metastatic breast cancer and documented BRCA1 or BRCA2 germline mutation, regardless of tumour steroid hormone receptor or HER-2 status OR...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

an open explorative phase II, open label study of olaparib in the treatment of advanced cancer in patients carrying a somatic or germline mutation in a homologous recombination gene.

Excerpt:
...1- Provision of informed consent prior to any study specific procedures 2- Female or male aged > 18 years 3- Histologically proven advanced cancer, either locally or metastatic, harboring a specific pathogenic genetic alteration (with the exception of breast, pancreas, ovarian or prostate cancer patients harboring a BRCA1/2 mutation) 4- No approved targeted therapy for the specific genetic alteration in the specific tumor type 5- No other genomic driven phase I, II or III trial available for the specific genomic alteration in the specific tumor type 6- Available tumor tissue for verification of the mutation by Sanger sequencing. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer

Excerpt:
...- Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan

Excerpt:
...Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious from germline or a tumour specimen, prior to provision of informed consent 5....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients

Excerpt:
...- Germline BRCA1 or BRCA2 mutation that is considered deleterious or suspected deleterious (include those mutations or translocations termed "deleterious" or "suspected deleterious" according to lab reporting)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer

Excerpt:
...For patients enrolling in the sporadic serous epithelial ovarian cancer group, Group B, a negative family history (BRCAPRO score less than or equal to 20% or negative BRCA1/2 mutation test)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

Excerpt:
...Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

NUVOLA TRIAL Open-label Multicentre Study

Excerpt:
...Documented mutation in BRCA1 or BRCA2 germline and/or somatic that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function); 4....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

98P - Olaparib (O) in patients (pts) with solid tumors with BRCA1/2 mutation (mut): Results from the targeted agent and profiling utilization registry (TAPUR) study

Published date:
09/05/2022
Excerpt:
32 pts with solid tumors with BRCA1 (N=13) or BRCA2 (N=19) mut were enrolled from July 2016 to December 2018. All pts were evaluable for efficacy and toxicity. The table shows demographics and outcomes. 2 CR (1 BRCA1, stomach cancer; 1 BRCA2, unknown primary), 6 PR (2 BRCA1; 4 BRCA2; all had unique primary tumors) and 5 SD16+ (1 BRCA1; 4 BRCA2; 2/5 pts colorectal cancer, 3/5 had unique primary tumors) were observed for DC rate of 41% (90% CI, 29% to 100%) and OR rate of 25% (95% CI, 11% to 43%). The null DC rate was rejected. 12 pts had ≥1 Grade 3/4 adverse or serious adverse event at least possibly related to O. O monotherapy demonstrated evidence of anti-tumor activity in pts with various solid tumors with BRCA1/2 mut.
Trial ID: