Capecitabine in Addition to Anthracycline- and Taxane-Based Neoadjuvant Treatment in Patients With Primary Breast Cancer: Phase III GeparQuattro Study

2010 ◽  
Vol 28 (12) ◽  
pp. 2015-2023 ◽  
Author(s):  
Gunter von Minckwitz ◽  
Mahdi Rezai ◽  
Sibylle Loibl ◽  
Peter A. Fasching ◽  
Jens Huober ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Breast Conservation ◽  
Growth Factor Receptor ◽  
Complete Response ◽  
Phase Iii ◽  
The Difference ◽  
Locally Advanced Tumors ◽  
Clinically Node Positive

Purpose Capecitabine can be integrated either concomitantly or sequentially to anthracycline-plus-taxane–based regimens. Patients and Methods Patients with large operable or locally advanced tumors, with hormone receptor–negative tumors, or with receptor-positive tumors but also clinically node-positive disease were recruited to receive preoperatively four cycles of epirubicin plus cyclophosphamide (EC; epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2). Patients were then randomly assigned to four cycles of docetaxel (100 mg/m2), four cycles of docetaxel + capecitabine (TX; docetaxel 75 mg/m2 plus capecitabine 1,800 mg/m2), or four cycles of docetaxel (75 mg/m2) followed by four cycles of capecitabine (1,800 mg/m2; T-X). Patients with human epidermal growth factor receptor 2 (HER-2) –positive tumors received trastuzumab concomitantly with all cycles. Primary objectives were to assess the effect of docetaxel by comparing EC plus docetaxel versus EC plus TX and to assess the effect of duration by comparing EC plus TX versus EC plus T-X on pathologic complete response (pCR, without invasive/noninvasive breast tumor, regardless of nodal status) at surgery, irrespective of trastuzumab treatment. Results Of 1,509 patients starting EC, 1,421 were randomly assigned to docetaxel (n = 471), TX (n = 471), or T-X (n = 479). At surgery, pCR rates were 22.3%, 19.5%, and 22.3%, respectively; the difference for docetaxel (EC plus docetaxel v EC plus TX) was 2.8% (95% CI, −2.4% to 8.0%; P = .298).The difference for duration was −2.8% (95% CI, −8.0% to 2.4%; P = .298). Breast conservation rates were 70.1%, 68.4%, and 65.3%, respectively (P = .781 for docetaxel; P = .270 for duration). Concomitant but not sequential treatment with docetaxel was associated with more diarrhea; nail changes, and hand-foot-syndrome, but it was associated with less edema. Conclusion Adding capecitabine to or prolonging duration of neoadjuvant EC plus docetaxel does not result in higher efficacy at surgery.

624 A PHASE III STUDY ON NEOADJUVANT TORIPALIMAB PLUS CHEMOTHERAPY VERSUS NEOADJUVANT CHEMOTHERAPY FOR LOCALLY RESECTABLE ESOPHAGEAL SQUAMOUS CELL CARCINOMA

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Yan Zheng ◽  
Jiangong Zhang ◽  
Wenqun Xing
Keyword(s):  
Phase Ii ◽  
Checkpoint Inhibitors ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
R0 Resection ◽  
Phase Iii Trial ◽  
Free Survival

Abstract   In recent years, immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of ESCC. More than 20 phase II clinical trials have been launched to explore combinations of ICIs in the neoadjuvant setting for ESCC. Based on our phase II clinical trial, a two-arm phase III trial was launched in our Hospital. Methods A two-arm phase III trial was launched in April 2020 in our Hospital. Patient recruitment will be completed within 18 months. The primary endpoint is event-free survival (EFS). The secondary endpoints include pathologic complete response (pCR), disease-free survival (DFS) rate, overall response rate (ORR), R0 resection rate, major pathologic response (MPR), adverse events (AEs), complication rate and quality of life (QOL). A biobank of pretreatment, resected tumor tissue and paired blood samples will be built for translational research in the future. Results Until Dec. 2021, one hundred and twenty ESCC patients recruited in the trial. The trial is ongoing. Conclusion This RCT directly compares NAC with neoadjuvant toripalimab plus chemotherapy in terms of EFS for locally advanced ESCC. The results may usher in a new era of resectable ESCC treatment.

740 CAMRELIZUMAB IN COMBINATION WITH PREOPERATIVE CHEMOTHERAPY FOR LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA: A SINGLE-ARM, OPEN-LABEL, PHASE II STUDY

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Feng Wang ◽  
Yu Qi ◽  
Xiangrui Meng ◽  
Qingxia Fan
Keyword(s):  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Reduction Rate ◽  
Complete Response ◽  
Pathologic Response ◽  
R0 Resection ◽  
Efficacy And Safety

Abstract   At present, ESCC has a dismal prognosis with huge unmet clinical needs. With the potential benefit of combining PD-1 inhibitor with nCT, we conducted a phase II trial to assess the efficacy and safety of Camrelizumab plus nCT for locally advanced ESCC. Methods 45 patients (pts) with histologically confirmed stage II/III/IVa(cT2-4aN0-3 M0) ESCC were enrolled from February 2020 to March 2021.The study was divided into two stages, stage1: we administered 1 cycle of Camrelizumab for induction therapy (200 mg q2 weeks); stage2: pts received 2 cycle of Camrelizumab (200 mg every 3 weeks) plus docetaxel and nedaplatin, followed by surgery within 4 ~ 6 weeks after neoadjuvant therapy completion. Primary endpoint was major pathologic response (MPR). Secondary endpoints included pathologic complete response (pCR), R0 resection rate, disease-free survival (DFS) and overall survival (OS). Results At the cutoff date of Mar 9, 2021, 45 eligible pts were enrolled, neoadjuvant treatment was completed in 39 pts. Thus far 32 pts were resected, all patients underwent an R0 resection. Postoperative pathology showed that TNM stage decreased in 28 pts with 87.5% reduction rate. 19 pts (59.38%) reached major pathologic response, 9 pts (28.13%) reached pathologic complete response (no surgery related mortality). A total of 75.56% had AEs with 13.33% of grade ≥ 3 AEs. Date for median DFS and OS were not matured. Conclusion Camrelizumab in combination with preoperative chemotherapy followed by surgery for locally advanced ESCC showed promising downstaging effect and MPR with good tolerance, and its efficacy and safety could be further studied in later trials. Clinical trial information: NCT03917966.

Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer

2018 ◽  
Vol 36 (10) ◽  
pp. 968-974 ◽  
Author(s):  
Xavier Pivot ◽  
Igor Bondarenko ◽  
Zbigniew Nowecki ◽  
Mikhail Dvorkin ◽  
Ekaterina Trishkina ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Epidermal Growth Factor Receptor ◽  
Adverse Event ◽  
Growth Factor ◽  
Response Rate ◽  
Pathologic Complete Response ◽  
Growth Factor Receptor ◽  
Complete Response ◽  
Phase Iii ◽  
Epidermal Growth

Purpose This phase III study compared SB3, a trastuzumab (TRZ) biosimilar, with reference TRZ in patients with human epidermal growth factor receptor 2–positive early breast cancer in the neoadjuvant setting ( ClinicalTrials.gov identifier: NCT02149524). Patients and Methods Patients were randomly assigned to receive neoadjuvant SB3 or TRZ for eight cycles concurrently with chemotherapy (four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide) followed by surgery, and then 10 cycles of adjuvant SB3 or TRZ. The primary objective was comparison of breast pathologic complete response (bpCR) rate in the per-protocol set; equivalence was declared if the 95% CI of the ratio was within 0.785 to 1.546 or the 95% CI of the difference was within ± 13%. Secondary end points included comparisons of total pathologic complete response rate, overall response rate, event-free survival, overall survival, safety, pharmacokinetics, and immunogenicity. Results Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95% CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within and the upper limit outside the equivalence margin. The total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively. Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively. Conclusion Equivalence for efficacy was demonstrated between SB3 and TRZ on the basis of the ratio of bpCR rates. Safety and immunogenicity were comparable.

Association of NBS1 expression with improved pathologic complete response rate in HER2-overexpressing breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e11534-e11534
Author(s):  
Fatma Sen ◽  
Ekrem Yavuz ◽  
Gulcin Yegen ◽  
Hasan Karanlik ◽  
Sitki Tuzlali ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Protein Expression ◽  
Response Rate ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Protein Loss ◽  
Paraffin Sections ◽  
Her2 Breast Cancer

e11534 Background: Our aim was to investigate potential correlation between expression levels of Nijmegen breakage syndrome1 (NBS1) protein and phosphatidylinositol-3 kinase (PI3K) and pathologic complete response (pCR) rate to neoadjuvant treatment in locally advanced HER2+ breast cancer. We also assess possible association between NBS1 and PI3K expressions. Methods: Totally 42 patients (median age 49 years), received neoadjuvant treatment due to locally advanced HER2+ breast cancer, were included. Immunohistochemical analyses were performed on paraffin sections, obtained during initial diagnosis. Paraffin sections were stained with anti-NBS1 (P95-NBS1 antibody, Y112, ab32074) and anti-PI3K (PI3-Kinase p85 alpha+gamma antibody, ab741369) antibodies to determine positivity of related proteins. Results: NBS1 protein loss was detected in 19 (%45) patients whereas p85 loss was shown in 25 (%60). There was no initial clinicopathologic variable predicting pCR. Fifteen of 30 patients, received neoadjuvant trastuzumab, had pCR, whereas only 1 of 12 patients, not received trastuzumab, achieved pCR (P = 0.012). p85 loss did not predict treatment response, however NBS1 protein expression positively correlated with increased response rate to neoadjuvant treatment (P = 0.007). Conclusions: NBS1 protein expression associates with increased pCR rate in HER2+ breast cancer. However, P85 positivity did not associate with pCR rate or NBS1 overexpression.

Circulating Biomarkers for Response Prediction of Rectal Cancer to Neoadjuvant Chemoradiotherapy

2020 ◽  
Vol 27 (25) ◽  
pp. 4274-4294 ◽  
Author(s):  
Chiara Bedin ◽  
Sara Crotti ◽  
Edoardo D’Angelo ◽  
Sara D’Aronco ◽  
Salvatore Pucciarelli ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Clinical Benefit ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Neoadjuvant Chemoradiotherapy ◽  
Treatment Protocol ◽  
Predictive Biomarkers ◽  
Complete Response ◽  
Tumour Regression

: Rectal cancer response to neoadjuvant Chemoradiotherapy (pCRT) is highly variable. In fact, it has been estimated that only about 21 % of patients show pathologic Complete Response (pCR) after therapy, while in most of the patients a partial or incomplete tumour regression is observed. Consequently, patients with a priori chemoradioresistant tumour should not receive the treatment, which is associated with substantial adverse effects and does not guarantee any clinical benefit. For Locally Advanced Rectal Cancer Patients (LARC), a standardized neoadjuvant treatment protocol is applied, the identification and the usefulness of prognostic or predictive biomarkers can improve the antitumoural treatment strategy, modifying the sequence, dose, and combination of radiotherapy, chemotherapy and surgical resection. : For these reasons, a growing number of studies are actually focussed on the discovery and investigation of new predictive biomarkers of response to pCRT. In this review, we have selected the most recent literature (2012-2017) regarding the employment of blood-based biomarkers potentially predicting pCR in LARC patients and we have critically discussed them to highlight their real clinical benefit and the current limitations of the proposed methodological approaches.

Weekly cetuximab (CET) plus oxaliplatin (OX), infusional 5-fluorouracil (5-FU) and radiation therapy (RT) as neoadjuvant treatment for esophageal squamous cell carcinoma (ESCC): A phase I study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15507-e15507
Author(s):  
F. Lordick ◽  
C. Meyer zum Büschenfelde ◽  
P. Thuss-Patience ◽  
N. Röthling ◽  
H. Geinitz ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Growth Factor Receptor ◽  
Complete Response ◽  
R0 Resection ◽  
Moderate Anemia ◽  
Hand Foot Syndrome ◽  
Ecog Ps

e15507 Background: CET, a chimeric monoclonal IgG1 antibody that targets the epidermal growth factor receptor (EGFR), has proven activity in a variety of SCC models in vitro and in vivo and has also been shown to enhance the activity of both chemo- and radiotherapy. Methods: Patients (pts) with locally advanced ESCC received CET for 2 weeks at an initial dose of 400mg/m2 (d - 15) i.v. followed by 250mg/m2(d -8) before they started a neoadjuvant dose escalation regimen. Pts received weekly CET 250mg/m2 plus RT 25 x 1.8 Gy (cumulative dose 45 Gy) d1–33. Cohort 1–3 received escalating doses of OX 45–50 mg/m2 d1,8,22,29 plus 5-FU 180–200–225 mg/m2/d; d1–5,8–12,15–19,22–26,29–33). Surgery was scheduled 4–6 weeks after RT. Toxicity was assessed according to NCI-CTC. Response was categorized according to the histopathologic score. Results: 15 pts were enrolled (2 female, 13 male; mean age 62 years, ECOG-PS 0 or 1). All pts had locally advanced SCC (uT2–4, cNx, cM0–1a) of the cervical (n=1), the upper (n=5) or the distal (n=7) esophagus. 6 pts were treated in cohort 1 and 3 pts in cohort 2 without any dose limiting toxicity (DLT). Of 6 pts treated in cohort 3, 1 pt developed grade 3 diarrhea and mucositis. All other observed toxicities were mild or moderate: anemia n=12, neutropenia n=2, thrombocytopenia n=3, nausea/vomiting n=8, mucositis n=6, diarrhea n=4, neuropathy n=4, hand-foot-syndrome n=8, skin rash n=14, no infection and no infusion-related reactions were observed. 12 pts underwent abdomino-thoracic esophagectomy with no postop. mortality; 3 pts were not resected. 8/12 resected pts had an R0 resection (67%) and 4 pts (33%) achieved a histopathological complete response (score 1a). Conclusions: 2 weeks of CET (400mg/m2 and 250mg/m2) followed by weekly CET (250mg/m2) plus OX 50mg/m2 d1,8,22,29, 5-FU 225 mg/m2/d d1–5,8–12,15–19,22–26,29–33 and RT 45 Gy (1.8Gy/f) was shown to be safe as neoadjuvant treatment for locally advanced ESCC. The anti-tumor activity of this regimen is promising and is being further investigated in an ongoing phase II study. [Table: see text]

Randomized, open-label, phase II study comparing the efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal b/HER2 normal breast cancer (GENEVIEVE).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS1138-TPS1138
Author(s):  
Stefan Paepke ◽  
Sherko Kümmel ◽  
Jens U. Blohmer ◽  
Serban Dan Costa ◽  
Holger Eidtmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Objective Response ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Breast Conservation ◽  
Complete Response ◽  
Weekly Paclitaxel ◽  
Open Label ◽  
Luminal B

TPS1138 Background: Cabazitaxel is a new taxoid promoting the tubulin assembly in vitro and stabilizing microtubules against cold-induced depolymerization as efficiently as docetaxel. It has shown superior survival against mitoxantrone plus prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer pts leading to its registration. It showed a favorable toxicity profile with a low rate of alopecia. In the GENEVIEVE study it will be compared to weekly paclitaxel, which is currently most widely used in breast cancer (BC) pts. Methods: This is a prospective multicenter, randomized, open label study investigating efficacy and safety of cabazitaxel. Pts with uni- or bilateral primary BC (stage cT3/T2/T1c and cN+/T1c and pNSLN+), tumor lesion ≥ 2cm (palpation) or ≥ 1cm (sonography) and centrally confirmed TNBC or luminal B/HER2- can be included. Pts will be randomized to four q3w cabazitaxel (25mg/m² i.v.) vs. 12 q1w paclitaxel (80mg/m² i.v.). Randomization will be stratified by nodal status and subtype. Treatment will be given until surgery, disease progression, unacceptable toxicity or withdrawal of consent. The primary objective is pathologic complete response (pCR) (ypT0/is ypN0/+). Secondary objectives are pCR in stratified subgroups and by other definitions, objective response rate, pCR and local recurrence free survival in pts with clinical complete response and neg. core biopsy before surgery, breast conservation rate, toxicity, compliance, survival rates, biomarkers predicting response. Assuming 15% pCR in controls and targeting a smallest clinical improvement of 10% (i.e. pCR = 25% in experimental arm), a total of 326 pts (163/arm) are required for the one-sided proportion comparison test (α=0.1) with 80% power. The trial is registered under NCT01779479. Results: Recruitment is planned for 12 mths in 45 (+10 back-up) sites in Germany. 1st pt in is planned for Feb 2013. Conclusion: GENEVIEVE will rapidly and precisely compare efficacy and tolerability of cabacitaxel vs. paclitaxel to decide if further development in BC is reasonable. Clinical trial information: NCT01779479.

ECX as neoadjvuant chemotherapy for gastric cancer in South America.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15190-e15190
Author(s):  
Leandro Machado Colli ◽  
Antonio Carlos Godoy ◽  
Bruno Filardi ◽  
Jose Marcio Barros Figueiredo ◽  
José Sebastião Santos ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Disease Progression ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Progression Free Survival ◽  
Complete Response ◽  
Brazilian Population ◽  
South American ◽  
South American Population

e15190 Background: Gastric cancer is a common malignant disease with a high mortality rate. Neoadjuvant treatment is efficient, but not the first option for treatment in all countries. Studies of neadjuvant chemotherapy in gastric cancer in South American countries are lacking. The aim of this retrospective analysis was to investigate the use of the ECX (epirubicin, cisplatin, and capecitabine) regimen in the neoadjuvant therapy in a Brazilian population. Methods: 25 patients (median age, 61; range 36-78 years; 14 pts >60 years) with locally advanced gastric adenocarcinoma received three courses of preoperative chemotherapy with epirubicin 50 mg/m², day 1, cisplatin 60 mg/m², day 1, and capecitabine 625 mg/m² bid, days 2-21, of a 21-day cycle. Toxicity was assessed by the Common Toxicity Criteria (CTC) after every cycle. Progression-free survival (PFS) was defined as time from diagnosis to disease progression assessed by CT. Results: 21 pts completed all three planned cycles of neoadjuvant chemotherapy. Four patients receiced surgery earlier than planned due to bleeding (1), toxicity (1), abdominal infection (1), and non-adherence to treatment (1). Three patients could not be operated due to disease progression. 70% of operated patients had curative resection with two pathologic complete response. Only six out 25 patients had disease progression and only two died after a median follow-up of 11.5 months (range 3.4-20.2). Median PFS and overall survival were not reached. Toxicities grade 3-4 were neutropenia (28%), febrile neutropenia (8%), bleeding (8%), and heart failure (6,2%). Conclusions: ECX is a efficacious neoadjuvant treatment in the Brazilian population and also well tolerated and safe. However, more studies with a larger South American population are needed.

A randomised phase III trial comparing two dose-dense, dose-intensified approaches (EPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 518-518 ◽  
Author(s):  
Andreas Schneeweiss ◽  
Volker Moebus ◽  
Hans Tesch ◽  
Claus Hanusch ◽  
Carsten Denkert ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Stage ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Primary Objective ◽  
Early Stage Breast Cancer ◽  
Phase Iii ◽  
Luminal B

518 Background: The sequential use of intense does-dense (idd) epirubicin, paclitaxel, cyclophosphamide (EPC) and weekly paclitaxel/liposomal doxorubicin (+/- carboplatin (Cb) in triple negative breast cancer (TNBC) (PM(Cb)) are considered highly efficient regimens for high-risk early stage breast cancer (BC). Methods: GeparOcto (NCT02125344) patients (pts) received 18 weeks (wks) either EPC (3x E 150mg/m² q2w followed by 3x P225 mg/m² q2w followed by 3x C 2000mg/m² q2) or PM(Cb) (12x P 80mg/m² plus M 20 mg/m² q1w, plus Cb AUC 1.5 q1w in TNBC). For HER2+ BC trastuzumab 6 (8) mg/kg q3w and pertuzumab 420 (840) mg q3w cycles were given concomitantly with P and C. Pts with histologically confirmed, cT1c - cT4a-d BC and central receptor assessment were included. Pts with HER2+ or TNBC were eligible irrespective of nodal status, luminal B-like tumours only if pN+. Primary objective compared pathologic complete response (pCR) rates (ypT0/is ypN0). Sample size calculations assumed a pCR rate of 50% for EPC and 60% for PM(Cb), requiring 950 pts to show superiority of PM(Cb). Secondary objectives compared pCR rates within the stratified subgroups (BC subtype, HER2+ vs HER2- HR+ vs HER2- HR-), amongst others. Results: 961 pts were recruited between 12/2014 and 05/2016, 945 started treatment. Median age was 48 years, 4% T3, 2% T4d, 46% N+, 82% ductal invasive, 66% G3 tumors; 40% were HER2+, 43% TNBC. 347 pts reported SAEs (176 EPC/171 PM(Cb)) and 2 pts died. 35 pneumonias (2 EPC vs 33 PM(Cb)) and 18 pneumonitis (3 EPC vs 15 PM(Cb)) were reported. 16.4% pts with EPC and 33.8% with PM(Cb) discontinued treatment (p<0.001), mainly due to AEs (47 EPC vs 113 PM(Cb)). Mean treatment duration was 17 wks with EPC and 16 wks with PM(Cb). pCR rate was 48.3% with EPC and 47.6% with PM(Cb)(OR 0.97 (95%CI 0.75-1.25), p=0.876). pCR rate in TNBC was 48.5% with EPC and 51.7% with PM(Cb); in HER2+ 62.0% vs 57.4% and in Luminal B 14.1% vs 14.6%. Conclusions: In high-risk early stage breast cancer pts pCR rates of idd EPC compared to weekly PM(Cb) were not significantly different. PM(Cb) appeared to be less feasible. Clinical trial information: NCT02125344.

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