预约演示

更新于：2025-05-07

Grupo Español Investigacion Cancer Mama

私营公司|Spain

更新于：2025-05-07

概览

关联

项与 Grupo Español Investigacion Cancer Mama 相关的临床试验

NCT02032277

/ Completed临床3期

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

开始日期2014-04-02

申办/合作机构

AbbVie, Inc.

[+4]

NCT01899079

/ CompletedN/A

Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer, HR+ and Node -.

The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

开始日期2013-06-01

申办/合作机构

NS Wind Down Co., Inc.

[+5]

NCT01484080

/ Completed临床1/2期IIT

Phase I/II Randomized Clinical Trial of Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates

The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF 1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial design, comparing the efficacy vs. weekly paclitaxel alone, followed by surgery and subsequent standards of care (anthracycline based chemotherapy, radiation or hormonal blockade).

开始日期2011-10-01

申办/合作机构

Centro Nacional de Investigaciones Oncologicas CARLOS III

[+4]

100 项与 Grupo Español Investigacion Cancer Mama 相关的临床结果

登录后查看更多信息

0 项与 Grupo Español Investigacion Cancer Mama 相关的专利（医药）

登录后查看更多信息

项与 Grupo Español Investigacion Cancer Mama 相关的文献（医药）

2025-04-01·JAMA

Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer

Article

作者: Viale, Giuseppe ; El-abed, Sarra ; Steger, Günther G. ; Gelber, Richard ; Gluz, Oleg ; Perretti, Thomas ; Gal-Yam, Einav Nili ; Jassem, Jacek ; Bailey, Andrew ; Cameron, David A. ; Zimina, Anastasia ; Schmidt, Marcus ; Metzger, Otto ; Bajetta, Emilio ; Higgins, Michaela ; Gonzalez Farre, Xavier ; Shparyk, Yaroslav ; Winer, Eric ; Saji, Shigehira ; Shearer-Kang, Esther ; Jacot, William ; Ben-Baruch, Noa Efrat ; Ohno, Shinji ; Werutsky, Gustavo ; Guerrero Zotano, Angel ; Zarba, Jose ; Munzone, Elisabetta ; Shao, Zhimin ; Chiu, Joanne ; McArthur, Heather ; Molinero, Luciana ; Tseng, Ling-Ming ; Lee, Soo Chin ; Ignatiadis, Michail ; Piccart, Martine ; Dieterich, Max ; Chui, Stephen Y. ; Gomez, Henry ; de Azambuja, Evandro ; Im, Seock-Ah ; Moscetti, Luca

ImportanceTriple-negative breast cancer is an aggressive subtype with a high incidence in young patients, a high incidence in non-Hispanic Black women, and a high risk of progression to metastatic cancer, a devastating sequela with a 12- to 18-month life expectancy. Until recently, one strategy for treating early-stage triple-negative breast cancer was chemotherapy after surgery. However, it was not known whether the addition of immune therapy to postsurgery chemotherapy would be beneficial.ObjectiveTo evaluate the addition of immune therapy in the form of atezolizumab to postoperative chemotherapy in patients with the high-risk triple-negative breast cancer subtype.Design, Setting, and ParticipantsIn this open-label international randomized phase 3 trial conducted in more than 330 centers in 31 countries, patients undergoing surgery as initial treatment for stage II or III triple-negative breast cancer were enrolled between August 2, 2018, and November 11, 2022. The last patient follow-up was on August 18, 2023.InterventionsPatients were randomized (1:1) to receive standard chemotherapy for 20 weeks with (n = 1101) or without (n = 1098) the immune therapy drug atezolizumab for up to 1 year.Main Outcomes and MeasuresThe primary end point was invasive disease-free survival (time between randomization and invasive breast cancer in the same or opposite breast, recurrence elsewhere in the body, or death from any cause).ResultsThe median age of enrolled patients was 53 years and most self-reported as being of Asian or White race and neither Latino nor Hispanic ethnicity. The study independent data monitoring committee halted enrollment at 2199 of 2300 planned patients. All patients stopped atezolizumab following a planned early interim and futility analysis. The trial continued to a premature final analysis. With invasive disease-free survival events in 141 patients (12.8%) treated with atezolizumab-chemotherapy and 125 (11.4%) with chemotherapy alone (median follow-up, 32 months), the final stratified invasive disease-free survival hazard ratio was 1.11 (95% CI, 0.87-1.42; P = .38). Compared with chemotherapy alone, the regimen of atezolizumab plus chemotherapy was associated with more treatment-related grade 3 or 4 adverse events (54% vs 44%) but similar incidences of fatal adverse events (0.8% vs 0.6%) and adverse events leading to chemotherapy discontinuation. Chemotherapy exposure was similar in the 2 treatment groups.Conclusions and RelevanceThe addition of the immune therapy drug atezolizumab to chemotherapy after surgery did not provide benefit among patients with triple-negative breast cancer who are at high risk of recurrent disease.Trial RegistrationClinicalTrials.gov Identifier: NCT03498716

2025-02-01·Annals of Oncology

TNBC-DX genomic test in early-stage triple-negative breast cancer treated with neoadjuvant taxane-based therapy

Article

作者: Prat, A. ; Stecklein, S.R. ; Uleer, C ; Grischke, E.-M. ; Paré, L ; Moreno, F ; Uleer, C. ; Hackmann, J ; Prat, A ; Warm, M. ; Gluz, O. ; López-Tarruella, S ; Bohn, U. ; Schumacher, C. ; Bueno-Muiño, C. ; Herrero, B ; Sharma, P ; Kuemmel, S. ; Harbeck, N ; Monte-Millán, M ; Bueno, O. ; Aktas, B. ; Brasó-Maristany, F. ; Kates, R ; Conte, B ; Echavarría, I ; Nitz, U ; Bueno, O ; Vivancos, A. ; Cebollero, M. ; Braun, M. ; Martín, M ; Parker, J.S. ; Villacampa, G ; Gluz, O ; Graeser, M. ; Braun, M ; Christgen, M. ; Villagrasa, P ; López-Tarruella, S. ; Massarrah, T. ; Gómez, H ; Jerez, Y ; Aktas, B ; Cobo, S. ; Bohn, U ; Kolberg-Liedtke, C ; Warm, M ; Grischke, E-M ; Parker, J S ; Conte, B. ; Sanfeliu, E. ; Kreipe, H.H. ; García-Saenz, J Á ; Christgen, M ; Graeser, M ; Eulenburg, C. ; Kates, R. ; Schumacher, C ; Álvarez, E L ; Kreipe, H H ; Harbeck, N. ; Villacampa, G. ; Kolberg-Liedtke, C. ; Nitz, U. ; Jerez, Y. ; Vivancos, A ; García-Saenz, J.Á. ; Perou, C.M. ; Monte-Millán, M. ; Herrero, B. ; Sanfeliu, E ; Bueno-Muiño, C ; Forstbauer, H. ; Cebollero, M ; Moreno, F. ; Wuerstleins, R. ; Paré, L. ; Cobo, S ; Zu Eulenburg, C ; Forstbauer, H ; Wuerstleins, R ; Villagrasa, P. ; Hackmann, J. ; Perou, C M ; Sharma, P. ; Stecklein, S R ; Echavarría, I. ; Brasó-Maristany, F ; Massarrah, T ; Kuemmel, S ; Martín, M. ; Álvarez, E.L. ; Gómez, H.

BACKGROUNDIdentification of biomarkers to optimize treatment strategies for early-stage triple-negative breast cancer (TNBC) is crucial. This study presents the development and validation of TNBC-DX, a novel test aimed at predicting both short- and long-term outcomes in early-stage TNBC. The objective of this study was to evaluate the association between TNBC-DX and efficacy outcomes [pathologic complete response (pCR), distant disease-free survival (DDFS) or event-free survival (EFS), and overall survival (OS)] in the validation cohorts.METHODSInformation from 1259 patients with early-stage TNBC (SCAN-B, CALGB-40603, and BrighTNess) was used to establish the TNBC-DX scores. Independent validation of TNBC-DX was carried out in three studies: (i) WSG-ADAPT-TN; (ii) MMJ-CAR-2014-01; and (iii) NeoPACT, including 527 patients with stage I-III TNBC undergoing neoadjuvant chemotherapy. In WSG-ADAPT-TN, patients were randomized to receive nab-paclitaxel plus gemcitabine or carboplatin. In MMJ-CAR-2014-01, patients received carboplatin plus docetaxel. In NeoPACT, patients received carboplatin plus docetaxel and pembrolizumab.RESULTSTNBC-DX test was created incorporating the 10-gene Core Immune Gene module, the 4-gene tumor cell proliferation signature, tumor size, and nodal staging. In the two independent validation cohorts without pembrolizumab, the TNBC-DX pCR score was significantly associated with pCR after adjustment for clinicopathological variables and treatment regimen [odds ratio per 10-unit increment 1.34, 95% confidence interval (CI) 1.20-1.52, P < 0.001]. pCR rates for the TNBC-DX pCR-high, pCR-medium, and pCR-low categories were 56.3%, 53.6%, and 22.5% respectively (odds ratio for pCR-high versus pCR-low 3.48, 95% CI 1.72-7.15, P < 0.001). In addition, the TNBC-DX risk score was significantly associated with DDFS [hazard ratio (HR) high-risk versus low-risk 0.24, 95% CI 0.15-0.41, P < 0.001] and OS (HR 0.19, 95% CI 0.11-0.35, P < 0.001). In the validation cohort with pembrolizumab, the TNBC-DX scores were significantly associated with pCR, EFS, and OS.CONCLUSIONSTNBC-DX predicts pCR to neoadjuvant taxane-carboplatin in stage I-III TNBC and helps to forecast the patient's long-term survival in the absence of neoadjuvant anthracycline-cyclophosphamide, and independent of pembrolizumab use.

2024-05-15·Clinical Cancer Research

Tumor-Infiltrating Lymphocytes Refine Outcomes in Triple-Negative Breast Cancer Treated with Anthracycline-Free Neoadjuvant Chemotherapy

Article

作者: Cebollero, María ; Massarrah, Tatiana ; O'Dea, Anne P. ; Yoder, Rachel ; Jerez, Yolanda ; Staley, Joshua M. ; Martín, Miguel ; Echavarría, Isabel ; Khan, Qamar J. ; Salgado, Roberto ; Nye, Lauren E. ; López-Tarruella, Sara ; Bueno, Coralia ; Álvarez, Enrique L. ; Stecklein, Shane R. ; García Saenz, José Ángel ; Bueno, Oscar ; Godwin, Andrew K. ; Moreno, Fernando ; Gómez, Henry ; del Monte-Millán, María ; Sharma, Priyanka ; Bohn, Uriel

AbstractPurpose:Stromal tumor-infiltrating lymphocytes (sTIL) are associated with pathologic complete response (pCR) and long-term outcomes for triple-negative breast cancer (TNBC) in the setting of anthracycline-based chemotherapy. The impact of sTILs on refining outcomes beyond prognostic information provided by pCR in anthracycline-free neoadjuvant chemotherapy (NAC) is not known.Experimental Design:This is a pooled analysis of two studies where patients with stage I (T>1 cm)–III TNBC received carboplatin (AUC 6) plus docetaxel (75 mg/m2; CbD) NAC. sTILs were evaluated centrally on pre-treatment hematoxylin and eosin slides using standard criteria. Cox regression analysis was used to examine the effect of variables on event-free survival (EFS) and overall survival (OS).Results:Among 474 patients, 44% had node-positive disease. Median sTILs were 5% (range, 1%–95%), and 32% of patients had ≥30% sTILs. pCR rate was 51%. On multivariable analysis, T stage (OR, 2.08; P = 0.007), nodal status (OR, 1.64; P = 0.035), and sTILs (OR, 1.10; P = 0.011) were associated with pCR. On multivariate analysis, nodal status (HR, 0.46; P = 0.008), pCR (HR, 0.20; P < 0.001), and sTILs (HR, 0.95; P = 0.049) were associated with OS. At 30% cut-point, sTILs stratified outcomes in stage III disease, with 5-year OS 86% versus 57% in ≥30% versus <30% sTILs (HR, 0.29; P = 0.014), and numeric trend in stage II, with 5-year OS 93% versus 89% in ≥30% versus <30% sTILs (HR, 0.55; P = 0.179). Among stage II–III patients with pCR, EFS was better in those with ≥30% sTILs (HR, 0.16; P, 0.047).Conclusions:sTILs density was an independent predictor of OS beyond clinicopathologic features and pathologic response in patients with TNBC treated with anthracycline-free CbD chemotherapy. Notably, sTILs density stratified outcomes beyond tumor–node–metastasis (TNM) stage and pathologic response. These findings highlight the role of sTILs in patient selection and stratification for neo/adjuvant escalation and de-escalation strategies.

100 项与 Grupo Español Investigacion Cancer Mama 相关的药物交易

登录后查看更多信息

100 项与 Grupo Español Investigacion Cancer Mama 相关的转化医学

登录后查看更多信息