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3ms
SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells (clinicaltrials.gov)
P1, N=10, Recruiting, General Oncology, Inc. | Trial completion date: Dec 2025 --> Aug 2027 | Trial primary completion date: Dec 2025 --> Aug 2026
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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HER-2 negative • PALB2 mutation
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BRACAnalysis CDx™
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carmustine • melphalan • Mustargen (mechlorethamine)
5ms
Two-hit events occurred independently in bilateral breast cancers in a germline double heterozygous carrier for BRCA1 and BRCA2. (PubMed, Breast Cancer)
These data provide evidence of different carcinogenesis between left and right breast cancer. Clinical and pathogenic characteristics of cancers with GDH for BRCA1 and BRCA2 depend on the genes somatically mutated in wild alleles.
Journal • BRCA Biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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BRACAnalysis CDx™
11ms
Olaparib as treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency: Phase 2 LIGHT study final overall survival analysis. (PubMed, Cancer)
Olaparib treatment continued to demonstrate benefit across all cohorts. Consistent with the primary analysis, the highest OS rates were observed in the BRCAm cohorts, regardless of g/sBRCAm. In patients without a BRCAm, a higher OS rate was observed in the HRD-positive non-BRCAm than the HRD-negative cohorts. These results highlight the importance of biomarker testing in this treatment setting.
P2 data • Journal • BRCA Biomarker • PARP Biomarker
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HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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HRD • BRCA mutation
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BRACAnalysis CDx™ • Myriad myChoice® CDx
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Lynparza (olaparib)
1year
High likelihood of BRCA2 reversion mutation in pancreatic cancer post-platinum-based chemotherapy: a case study. (PubMed, Int Cancer Conf J)
Despite treatment with PARPi for postoperative recurrence, a sustained response was not achieved owing to BRCA reversion mutations. It is essential to acknowledge the rarity of BRCA reversion mutations, which limit the effectiveness of PARPi.
Journal • PARP Biomarker • BRCA Biomarker
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BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CA 19-9 (Cancer antigen 19-9)
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BRCA2 mutation • BRCA mutation
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FoundationOne® CDx • BRACAnalysis CDx™
over1year
Trial completion • Metastases
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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BRACAnalysis CDx™
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Talzenna (talazoparib)
over1year
Clinical significance of germline breast cancer susceptibility gene (gBRCA) testing and olaparib as maintenance therapy for patients with pancreatic cancer. (PubMed)
"The gBRCA testing should be considered proactively, especially in patients with PC with a family history of HBOC-related cancer."
Journal
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BRACAnalysis CDx™
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Lynparza (olaparib) • 5-fluorouracil • irinotecan • leucovorin calcium
over1year
A Case of Breast Cancer Metastasis to the Uterus (JBCS 2024)
She was diagnosed with recurrent breast cancer (other: pectoralis major muscle, mediastinal and right parasternal connective tissue), and treatment was started with endocrine therapy (anastrozole)...Abemaciclib was added to fulvestrant, but 5 months later, the patient developed a cough and CT scans showed interstitial pneumonia...Treatment was continued with Avastin + paclitaxel, and the patient maintained stable disease...Since gynecological malignant tumors generally have a poorer prognosis than breast cancer, it was considered necessary to cooperate with the gynecology department regarding the treatment plan. Conclusion We report a rare case of uterine metastasis from breast cancer, adding some literature review
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • CDH1 (Cadherin 1)
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BRACAnalysis CDx™
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Avastin (bevacizumab) • paclitaxel • Verzenio (abemaciclib) • fulvestrant • anastrozole
over1year
A case of male breast cancer with a pathogenic variant in BRCA2 (JBCS 2024)
Weekly Paclitaxel therapy was scheduled as preoperative chemotherapy, followed by AC therapy...Postoperative adjuvant therapy will be AC therapy, followed by radiation therapy, followed by hormone therapy, with the addition of Olaparib...Since male breast cancer frequently has BRCA2 pathogenic variants, is often discovered at an advanced stage, and is recommended to be treated in the same way as female breast cancer, it was thought that there would be great benefits to performing BRCA genetic testing. In the future, it will be necessary to proceed with screening for prostate cancer and genetic counseling for blood relatives, and to utilize the results of this genetic test in the health management of the patient and his/her blood relatives
Clinical • PARP Biomarker • BRCA Biomarker
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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BRACAnalysis CDx™
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Lynparza (olaparib) • paclitaxel
over1year
A case of triple negative breast cancer with cold agglutinin disease and difficulty in perioperative drug therapy (JBCS 2024)
After that, because it was difficult to obtain intravenous drip infusion, a CV port was placed in the right subclavian vein, and docetaxel therapy was initiated...In the fourth course, perhaps because G-Lasta was administered, no FN was observed, but anemia with Hb of 5.0 was observed and a blood transfusion was required...In this case, the patient had triple-negative breast cancer with cold agglutinin disease, but during postoperative chemotherapy, she developed FN and severe anemia, making treatment difficult. It seems important to educate patients about infection control and to visit a hospital when they experience symptoms of anemia
Clinical
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HER-2 (Human epidermal growth factor receptor 2)
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BRACAnalysis CDx™
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docetaxel • Neulasta (pegfilgrastim)
over1year
A study of eight cases of male breast cancer (JBCS 2024)
Seven cases were administered TAM after surgery. In one case of encapsulated papillary carcinoma, the father and aunt had breast cancer, and the family history suggested the possibility of a positive BRACAnalysis, but the result was negative, which was an extremely interesting result
Clinical
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BRACAnalysis CDx™
over1year
Study on AYA generation breast malignant tumors at our hospital (JBCS 2024)
Since BRACAnalysis became covered by insurance, BRCA genetic testing has been actively conducted, but because this case occurred at a young age, it is thought that genetic testing is necessary again for past cases. In addition, it was thought that there is a need to improve team medical care for the unique nature of diagnosis and treatment during pregnancy and childbirth, fertility, breast reconstruction, etc
Clinical • BRCA Biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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BRACAnalysis CDx™
over1year
A case of sudden respiratory failure during treatment for recurrent breast cancer, clinically diagnosed as pulmonary tumor thrombotic microangiopathy (JBCS 2024)
The patient had PD-L1 CPS of 10 or higher, and pembrolizumab + gemcitabine + carboplatin was started in March. Two weeks after admission, the patient's respiratory condition worsened, he developed DIC, and passed away. [Discussion] Pulmonary tumor thrombotic microangiopathy (PTTM) is a rare condition, but in cases of rapidly progressing respiratory failure in cancer patients, PTTM must be kept in mind when carrying out differential diagnosis and treatment
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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BRACAnalysis CDx™
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Keytruda (pembrolizumab) • carboplatin • gemcitabine