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Clinical Trialsnsabpwordpress2021-04-16T10:39:54-05:00

StudyTitleStatusPhaseDisease SiteTarget AccrualAccrual to DateLast Regulatory Update
NSABP B-59A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Aztezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo13Breast1,5201,55006/01/2021
NSABP FB-12An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant ACT+Trastuzumab and Pertuzumab in Early Stage HER-2 Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER-2 Signaling Transduction02Breast54909/14/2021
NSABP FB-14A Phase II Clinical Trial of Pembrolizumab in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer32Breast29507/02/2021
NSABP FC-10A Phase IB Study of Pembolizumab in Combination with Pemetrexed and Oxaliplatin in Subjects with Chemo-refractory Metastatic Colorectal Cancer11-BColorectal333507/02/2021
NSABP FC-11A Phase II Study Evaluating the Combination of Neratinib Plus Trastuzumab or Neratinib Plus Cetuximab in Patients with "Quadruple Wild-Type" (KRAS/NRAS/BRAF/PIK3CA Wild-Type) Metastatic Colorectal Cancer Based on HER2 Status: Amplified, Non-Amplified (Wild-Type) or Mutated12Colorectal352507/02/2021
NSABP B-54-IPhase III Study Evaluating Palbociclib (PD-0332991) and a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients with Hormone-Receptor Positive, HER2-normal Primary Breast Cancer with High Relapse Risk after Neoadjuvant Chemotherapy (PENELOPE) Global Accrual = 125023Breast17117102/02/2021
NSABP B-56-IA Randomized, Placebo-Controlled, Double Blind Phase 3 Study Evaluating the Safety and Efficacy of the Addition of Velaparib Plus Carboplatin versus the Addition of Carobplatin to Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (Abbvie) Global Accrual = 63433Breast161601/20/2021
NSABP B-57-IPALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer (PALLAS) Global Accrual = 579323Breast43943901/15/2021
NSABP B-58A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High-Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer23Breast15019011/20/2020
NSABP B-50-IA Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine versus Trastuzumab as Adjuvant Therapy for Patients with HER2 Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes following Preoperative Therapy (KATHERINE) Global Accrual = 148723Breast36636107/23/2020
NSABP FB-10 Phase 1BA Phase 1B/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DMI) with Neratinib in Women with Metastatic HER2-Positive Breast Cancer31-BBreast412807/06/2021
NSABP FB-10 Phase IIA Phase 1B/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DMI) with Neratinib in Women with Metastatic HER2-Positive Breast Cancer32Breast222207/06/2021
NSABP FB-13An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) with Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients with Premenopausal Estrogen-Receptor Positive, HER2-Negative Primary Breast Cancer32Breast762407/06/2021
NSABP FR-2A Phase II Study to Assess the Activity of PD-L 1 Inhibition with Durvalumab (MEDI4736) after Chemo-Radiotherapy in Patients with Stage II-IV Microsatellite Stable (MSS) Rectal Cancer32Colorectal414507/06/2021
NSABP B-60A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy03Breast2754908/20/2021
NSABP B-61 lidERAA Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant GDC-9545 Compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen-Receptor Positive , HER2 Negative Early Breast Cancer03Breast3507908/20/2021
NSABP C-14CORRECT- MRD II: Second COloRectal cancer clinical validation study to predict REcurrence using a Circulating Tumor DNA assay to detect Minimal Residual Disease.0OBSColorectal750157
NSABP FC-12A Single Arm Phase II Study to Evaluate Treatment with Gevokizumab in Patients with Stage II/III Colon Cancer who are ctDNA-positive after Curative Surgery and Adjuvant Chemotherapy32Colorectal310
StudyTitleStatusPhaseDisease SiteTarget AccrualAccrual to DateLast Regulatory Update

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