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Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I –III HER2-positive breast cancer

AbstractPurposeThe purpose of this two-cohort Phase II trial was to estimate the pathologic complete response (pCR: ypT0/is ypN0) rate when trastuzumab plus pertuzumab are administered concurrently during both the taxane and anthracycline phases of paclitaxel and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) neoadjuvant chemotherapy.MethodsThe pCR rates were assessed separately in hormone receptor (HR) positive and negative cases following Simon ’s two-stage design, aiming to detect a 20% absolute improvement in pCR rates from 50 to 70 and 70 to 90% in the HR-positive and HR-`negative cohorts, respectively.ResultsThe HR-negative cohort completed full accrual of 26 patients; pCR rate was 80% (95% CI 60 –91%). The HR+ cohort was closed early after 24 patients due to lower than expected pCR rate of 26% (95% CI 13–46%) at interim analysis. Overall, 44% of patients (n = 22/50) experienced grade 3/4 adverse events. The most common were neutropenia (n = 10) and diarrhea (n = 7). There was no symptomatic heart failure, but 28% (n = 14) had ≥ 10% asymptomatic decrease in LVEF; in one patient, LVEF decreased to 
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research

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CONCLUSION: The TCH protocol is an efficacious neoadjuvant chemotherapy regimen for locally advanced and oligometastatic breast cancer and is safe and well tolerated in this population.
Source: Indian Journal of Cancer - Category: Cancer & Oncology Authors: Source Type: research
Conclusion.The incidence of NYHA class III/IV heart failure after neoadjuvant AC‐THP (followed by adjuvant trastuzumab‐based therapy) is comparable to rates reported in trials of sequential doxorubicin and trastuzumab. Our findings do not suggest an increased risk of cardiotoxicity from trastuzumab plus pertuzumab following a doxorubicin‐based regimen.Implications for Practice.Dual anti‐human epidermal growth receptor 2 (HER2) therapy with trastuzumab and pertuzumab combined with standard chemotherapy has received accelerated approval for the neoadjuvant treatment of stage II–III HER2‐positive breast cancer...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Breast Cancer Source Type: research
CONCLUSION: The incidence of NYHA class III/IV heart failure after neoadjuvant AC-THP (followed by adjuvant trastuzumab-based therapy) is comparable to rates reported in trials of sequential doxorubicin and trastuzumab. Our findings do not suggest an increased risk of cardiotoxicity from trastuzumab plus pertuzumab following a doxorubicin-based regimen. The Oncologist 2017;22:1-6Implications for Practice: Dual anti-human epidermal growth receptor 2 (HER2) therapy with trastuzumab and pertuzumab combined with standard chemotherapy has received accelerated approval for the neoadjuvant treatment of stage II-III HER2-positive ...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research
Conclusion If we can demonstrate that the use of an ACE inhibitor or a BB can reduce the degree of TZB-induced cardiotoxicity it is hoped that patients will receive complete and uninterrupted TZB therapy for breast cancer without compromising cardiac function. Clinical trial registration SCUSF 0806 NCT01009918 (url https://clinicaltrials.gov/ct2/show/NCT01009918).
Source: American Heart Journal - Category: Cardiology Source Type: research
Conclusion: In patients with HER2-positive breast cancer treated with neoadjuvant dose-dense AC and THP followed by completion of anti-HER2 therapy in adjuvant setting, the overall rate of NYHA Class III/IV heart failure was comparable to rates reported in trials of sequential doxorubicin and trastuzumab. Our findings do not suggest an increased risk of cardiotoxicity when pertuzumab is added to trastuzumab following a doxorubicin-based regimen.Citation Format: Xu L, Monga V, Thomas A, Leone JP. The impact of the presence of ductal carcinoma in situ in patients with invasive ductal carcinoma [abstract]. In: Proceedings of ...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Poster Session Abstracts Source Type: research
We report cardiac and overall safety as well as total pCR (tpCR) rates with widely used but understudied anthracycline-containing regimens.Methods: BERENICE (NCT02132949), a non-randomized, open-label, phase II study, enrolled patients (pts) with centrally confirmed HER2-positive, locally advanced, inflammatory, or early-stage, unilateral, and invasive breast cancer, Eastern Cooperative Oncology Group performance status ≤1, and baseline left ventricular ejection fraction (LVEF) ≥55%. In the neoadjuvant period, Cohort A pts received four q2w dose-dense doxorubicin+cyclophosphamide cycles (60 mg/m2/600 mg/m2 with granu...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Poster Session Abstracts Source Type: research
Abstract This meta‐analysis compared the efficiency and safety of lapatinib and trastuzumab, alone or in combination, administered with neoadjuvant chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)‐positive breast cancer. For dichotomous variables, the relative risk ratio (RR) and 95% confidence interval (CI) were used to investigate outcome measures: pathological complete response (pCR), neutropenia, diarrhea, dermatologic toxicity, and congestive heart failure (CHF). Eight randomized controlled trials of 2350 participants (837 receiving lapatinib, 913 trastuzumab, and 555 combination thera...
Source: Cancer Medicine - Category: Cancer & Oncology Authors: Tags: Original Research Source Type: research
Conclusion Neoadjuvant TCH-P, in a nonclinical trial setting, was associated with a pCR rate of 53 % similar the reported rate in TRYPHAENA. Toxicity was manageable, with no patients experiencing symptomatic heart failure.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
Conclusions The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.
Source: International Journal of Clinical Pharmacy - Category: Drugs & Pharmacology Source Type: research
Conclusion The triple combination therapy assessed is effective and safe, offering a high pCR rate in patients with HER2-positive BC.
Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
More News: Breast Cancer | Cancer | Cancer & Oncology | Cardiology | Chemotherapy | Heart | Heart Failure | HER2 | Herceptin | Hormones | Neoadjuvant Chemotherapy Therapy | Neoadjuvant Therapy