- |||||||||| paclitaxel / Generic mfg.
Clinical, Journal, HEOR: Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)-Positive Breast Cancer. (Pubmed Central) - Jan 21, 2021 The KATHERINE trial showed that adjuvant trastuzumab emtansine (T-DM1) can reduce recurrence in patients with residual disease compared with patients treated with trastuzumab; however, T-DM1 and other ERBB2-targeted agents are costly, and understanding the costs and health consequences of various combinations of neoadjuvant followed by adjuvant treatments in the United States is needed...There were 4 neoadjuvant regimens: (1) HP: trastuzumab (H) plus pertuzumab (P), (2) THP: paclitaxel (T) plus H plus P, (3) DDAC-THP: dose-dense anthracycline/cyclophosphamide (DDAC) plus THP, (4) TCHP: docetaxel (T) plus carboplatin (C) plus HP...Probabilistic analysis confirmed that this strategy had the highest probability of cost-effectiveness (>70% at willingness-to-pay thresholds of $0-200,000/QALY) and was associated with the highest net benefit. These results suggest that neoadjuvant THP followed by adjuvant H for patients with pCR or followed by adjuvant DDAC plus T-DM1 for patients with residual disease was associated with the highest health benefits and lowest costs for women with ERBB2-positive breast cancer compared with other treatment strategies considered.
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer (clinicaltrials.gov) - Jan 20, 2021 P2a, N=50, Recruiting, These results suggest that neoadjuvant THP followed by adjuvant H for patients with pCR or followed by adjuvant DDAC plus T-DM1 for patients with residual disease was associated with the highest health benefits and lowest costs for women with ERBB2-positive breast cancer compared with other treatment strategies considered. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Review, Journal: Early HER2-Positive Breast Cancer: Current Treatment and Novel Approaches. (Pubmed Central) - Jan 16, 2021
Adding HER2 blockade to adjuvant trastuzumab with pertuzumab and neratinib improves invasive disease-free survival (IDFS), particularly for those at highest risk of recurrence...For patients without a pathological complete response (pCR) after the neoadjuvant part of the therapy, a switch to adjuvant trastuzumab emtansine significantly improves IDFS and distant recurrence-free survival and shows a trend towards improved overall survival (OS)...Neoadjuvant therapy should be offered for a significant proportion of HER2-positive early breast cancer patients with a higher risk of recurrence. Postneoadjuvant treatment should be tailored according to the initial stage of disease and the response to neoadjuvant treatment.
- |||||||||| Review, Journal: Metastatic Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Current Treatment Standards and Future Perspectives. (Pubmed Central) - Jan 16, 2021
Dual HER2 blockade with pertuzumab and trastuzumab in combination with docetaxel in previously untreated patients, and trastuzumab emtansine (T-DM1, an antibody-drug conjugate [ADC] consisting of trastuzumab, a linker and a cytotoxic payload) after prior trastuzumab therapy have demonstrated progression-free survival (PFS) and overall survival (OS) superior to what was achieved with the previous treatment routine...Accepted options include treatment with trastuzumab beyond progression, in combination with a broad variety of single-agent chemotherapies used sequentially, or lapatinib (an HER2-targeting tyrosine kinase inhibitor [TKI]) in combination with either trastuzu-mab or capecitabine...After a median of 6 prior lines of therapy, trastuzumab deruxtecan (T-DXd), a novel ADC, showed a meaningful overall response and PFS...Tucatinib, neratinib, margetuximab, and T-DXd expand the armamentarium for treatment beyond the second line. Pyrotinib might be another option, especially for patients, who do not have access to pertuzumab and T-DM1.
- |||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Metastases: DESTINY-Breast07: A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - Jan 13, 2021 P1b/2, N=350, Recruiting, Elderly patients who require neoadjuvant therapy may benefit from 6 cycles of THP treatment, based on its good efficacy and mild adverse events. Not yet recruiting --> Recruiting | Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial completion date, Trial initiation date, Trial primary completion date: Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer (clinicaltrials.gov) - Jan 11, 2021 P2, N=20, Not yet recruiting, Recruiting --> Completed | N=52 --> 8 | Trial completion date: Jun 2025 --> Jan 2021 | Trial primary completion date: Jun 2025 --> Jan 2021 Trial completion date: Dec 2023 --> Jun 2024 | Initiation date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| paclitaxel / Generic mfg.
Clinical, Journal, HEOR: Neoadjuvant treatment strategies for HER2-positive breast cancer: cost-effectiveness and quality of life outcomes. (Pubmed Central) - Jan 9, 2021 Trial completion date: Dec 2023 --> Jun 2024 | Initiation date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2022 An adaptive-treatment strategy beginning with neoadjuvant THP or TH followed by tailoring post-operative therapy reduces treatment costs, and spares toxicity compared to more intensive chemotherapy regimens for women with HER2-positive breast cancer.
- |||||||||| Herceptin (trastuzumab) / Roche
P2a data, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, Pan tumor: Targeted therapy for advanced salivary gland carcinoma based on molecular profiling: results from MyPathway, a phase IIa multiple basket study. (Pubmed Central) - Jan 9, 2021 P2a Overall, 12 of 19 patients (63%) with advanced SGC, treated with chemotherapy-free regimens matched to specific molecular alterations, experienced an objective response. Data from MyPathway suggest that matched targeted therapy for SGC has promising efficacy, supporting molecular profiling in treatment determination.
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: R2D2: Her2-positive Lung Cancer Treated With Dedicated Drug (clinicaltrials.gov) - Jan 6, 2021 P2, N=46, Active, not recruiting, Data from MyPathway suggest that matched targeted therapy for SGC has promising efficacy, supporting molecular profiling in treatment determination. Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Dec 2020 --> Jul 2021
- |||||||||| Perjeta (pertuzumab) / Roche
Journal: HER2-targeted therapy influences CTC status in metastatic breast cancer. (Pubmed Central) - Jan 6, 2021 HER2-targeted therapy seems to reduce the overall CTC count in patients with MBC. This should be taken into account when CTC status is used as an indicator for aggressive or indolent metastatic tumor disease.
- |||||||||| Spinraza (nusinersen) / Biogen, Ionis, Perjeta (pertuzumab) / Roche
Pricing, Journal, Orphan drug: Pricing of orphan drugs in oncology and rare diseases. (Pubmed Central) - Dec 17, 2020 The break-even price from only an investor perspective may not reflect the value of drug from a broader perspective. This study shows drug prices based on an innovation premium may be more representative of the actual value of innovation for the society.
- |||||||||| inavolisib (GDC-0077) / Roche
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: GO39374: To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer (clinicaltrials.gov) - Dec 10, 2020 P1, N=256, Recruiting, Active, not recruiting --> Completed N=104 --> 256 | Trial completion date: Dec 2020 --> Nov 2022 | Trial primary completion date: Dec 2020 --> Nov 2022
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