Breast Clinical Trials

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Breast clinical trials

RCN Canadian Nurses Association (CNA) Award Presentation - May 7, 2018

List of confirmed participants
           
           
#

Institution

First Name

Last Name

Title

Email

1 CIUSSS COIM Renata Benc Conseillère-cadre  (Cancer Care)  rbenc [at] jgh.mcgill.ca ()
2 CIUSSS COIM Antoinette Ehrler ‎Associate Nursing Director, Cancer Care aehrler [at] jgh.mcgill.ca ()
3 CIUSSS COIM Cherry Flores Head Nurse K7 (Hematology Oncology floor)  cflores [at] jgh.mcgill.ca ()
4 CIUSSS ODIM Maya Jeanty Chef d’unité clinique de cancérologie  maya.jeanty.chsm [at] ssss.gouv.qc.ca
5 CIUSSS ODIM Béatrice Petrescu Coordonnatrice aux opérations quotidiennes – accès à l’épisode de soins hospitaliers
Direction de soins infirmiers
beatrice.petrescu.comtl [at] ssss.gouv.qc.caa
6 MUHC Luisa Luciani Castiglia Conseillère en soins spécialisés en oncologie luisa.luciani.castiglia [at] muhc.mcgill.ca ()
7 MUHC Justine  De Monteiro Nurse Manager, Surgical Gyneoncology (C8) justine.demonteiro [at] muhc.mcgill.ca
8 McGill University Samuel Benaroya Associate Vice-Principal and Vice-Dean (Health Affairs)
Faculty of Medicine
samuel.benaroya [at] mcgill.ca ()
9 RCN Paola Gardere Program Manager, Cancer Quality & Innovation paola.gardere [at] muhc.mcgill.ca ()
10 RCN Sophie Lorenzo Communications Officer sophie.lorenzo [at] muhc.mcgill.ca ()
11 RCN Ari Meguerditchian Program Lead, Cancer Quality & Innovation ari.meguerditchian [at] mcgill.ca ()
12 RCN Tony Teti Director of Operations tony.teti [at] mcgill.ca ()
13 CNA Sylvain Brousseau Board Member  
Updated: May 1, 2018        
    or/Protocol ID clinicaltrials.gov Identifier (NCTxxx) Study Title Phase Name of PI (Hospital) Study Manager (Hospital) Study Coordinator (Hospital)/Extension MUHC: 514-934-1934 JGH: 514-340-8222 SMHC: 514-345-3511 Comments Basik (JGH) Linda Robitaille (JGH) Gabi Alexandru-Rolea 25526 (JGH) Lambert (MUHC) Penny Chipman (MUHC) Dianna Leroux Pager: 514-406-7410 2 KEYNOTE 522 Merck NCT03036488 A Randomized, Double-blind Phase III Study to Evaluate Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC) 3 Boileau (JGH) Linda Robitaille (JGH) Gladys El Helou (JGH) 25526 Tumour > 2 cm or > 1 cm & pN+ No prior chemotherapy, targeted or radiation therapy within past 12 months 3 IMpassion031 WO3932 NCT03197935 A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer 3 Ferrario (JGH) Linda Robitaille (JGH) Gladys El Helou (JGH) 25526 Tumour > 2 cm Stage at presentation: cT2−cT4, cN0−cN3, cM0 No previous anthracycline or taxane treatment Confirmed tumor PD-L1 4 NSABP B-59 NCT03281954 A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with TripleNegative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo 3 Boileau (JGH) Linda Robitaille (JGH) Gabi Alexandru-Rolea 25526 (JGH) Opening soon. Primary tumor T2 or T3 if N0 Primary tumor T1c, T2, or T3 if N+ No previous anthracycline or taxane treatment Boileau (JGH) Linda Robitaille (JGH) Gabi Alexandru-Rolea 25526 (JGH) 3 3 1 MAC 19 NCT01901094 A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy TNBC PALLAS 5 BREAST Neoadjuvant Adjuvant Surgical T1-3 N1 M0 Complete all chemotherapy prior to surgery A min 1 sentinel node, max 6 total nodes (sentinel + nonsentinel) are identified and excised by the surgeon At least 1 lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm NCT02513394 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) Prior (neo)adjuvant therapy and/or radiotherapy OK < 1 year since initial biopsy Stage 1 or 4 not eligible --> ARM II CLOSED > 2.0cm node negative ER+ 1/7 https://www.mcgill.ca/rcr-rcn/clinical-trials last updated: March 7, 2018 by Jida El Hajjar any comments or changes: jida.elhajjar [at] mail.mcgill.ca PLEASE REFER TO SOLID TUMORS CLINICAL TRIAL LIST FOR MORE OPTIONS Asselah (MUHC) Penny Chipman (MUHC) Rosie Santos Pager: 514-406-6566 6 NSABP B-58 NCT03155997 A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy vs Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer 3 Boileau (JGH) Linda Robitaille (JGH) Gabi Alexandru-Rolea 25526 (JGH) Negative margins following lump/masectomy (neo)adj and pN+ no prev endocrine therapy Thirlwell (MUHC) Stelliana Moreno (MUHC) Stelliana Moreno 43131 (MUHC) Boileau (JGH) Linda Robitaille 27562 (JGH) Gabi Alexandru-Rolea 25526 (JGH) 8 BRCA MA36 OlympiA NCT02032823 A randomized, double blind, parallel group, placebo-controlled multi-centre phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy 3 Ferrario (JGH) Aline Mamo (JGH) Kriti Arora 23766 (JGH) BRCA2+ Must be HER2- TNBC : pN0 > 2cm or pN+ ER + and/or PgR + : pN2; if Neoadjuvant non pCR 9 Her2+ PUMA-NER-6201 NCT02400476 An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis 2 Thirlwell (MUHC) Stelliana Moreno (MUHC) Stelliana Moreno 43131 (MUHC) Stage 1-3 Prior treatment with adjuvant herceptin Basik (JGH) Linda Robitaille (JGH) Gabi Alexandru-Rolea 25526 (JGH) Lambert (MUHC) Marianna Perna (MUHC) Tatiana Carvalho (MUHC) ext. 43698 Ginette Ricard (MUHC) ext 43186 Josie Pepe (MUHC) ext 48186 TNBC Metastatic All 3 3 pN+ eligible If pN0, tumor must be > 3.0 cm. 7 10 A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk NodeNegative Triple-Negative Invasive Breast Cancer NRG BR003 NCT02488967 PALLAS 5 RTOG 1304/NSABP B51 NCT01872975 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy 3 T1-T3 node positive Previous neoadjuvant treatment must be CHEMO not hormonal. Positive lymph nodes NCT02513394 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) Prior (neo)adjuvant therapy and/or radiotherapy OK < 1 year since initial biopsy Stage 1 or 4 not eligible --> ARM II CLOSED > 2.0cm node negative ER+ 2/7 https://www.mcgill.ca/rcr-rcn/clinical-trials last updated: March 7, 2018 by Jida El Hajjar any comments or changes: jida.elhajjar [at] mail.mcgill.ca PLEASE REFER TO SOLID TUMORS CLINICAL TRIAL LIST FOR MORE OPTIONS 11 ER+ SHERBOC NCT03241810 A Double-blind, Placebo-controlled, Phase 2 trial of Seribantumab Plus Fulvestrant in Postmenopausal Women with Hormone Receptorpositive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer 2 Ferrario (JGH) Aline Mamo (JGH) Kriti Arora 23766 (JGH) SECOND/THIRD LINE •Postmenopausal •HER2- •No prev trx with anti-ErbB3 antibody •No CNS disease Coming soon Bouganim (MUHC) Penny Chipman (MUHC) Rosie Santos Pager: 514-406-6566 Panasci (JGH) Adele Cascini (JGH) Sheila Rincon 24624 (JGH) 13 CR1322AZ NCT01226316 A Phase I, Open- Label, Multicenter, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advance Solid malignancies 1 Batist (JGH) Adele Cascini (JGH) Sheila Rincon 24624 (JGH) ALL LINES •ER positive, ANY HER2 status •No limit of previous lines •Any menopausal status •NO Diabetes •no previous Fulvestrant Batist (JGH) Adele Cascini (JGH) Amanda Kanesci (JGH) 26394 Bouganim (MUHC) Penny Chipman (MUHC) Shweta Jasra (MUHC) Pager: 514-406- 4655 12 14 AurKa CR1714AA CR1718GSK GSK 201973 A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With ER+ Breast Cancer NCT02964507 1/2 NCT03092934 FIRST LINE •Any menopausal status •Progressing within 12 months of adjuvant ET or previously treated for M1 disease with AI / Tam / CDK4/6i •Max 1 line of prior chemo for M1 •MEASURABLE disease only SECOND LINE •HER2 negative •Must have failed hormone therapy and CDK4/6 inhibitor •CNS mets ok as long as asymptomatic and no corticosteroids 1/2 A Phase I/II Open-Label Multicenter Study to Evaluate the Safety and Efficacy of AK-01 as Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumors 3/7 https://www.mcgill.ca/rcr-rcn/clinical-trials last updated: March 7, 2018 by Jida El Hajjar any comments or changes: jida.elhajjar [at] mail.mcgill.ca PLEASE REFER TO SOLID TUMORS CLINICAL TRIAL LIST FOR MORE OPTIONS 15 TNBC IMMU-132-05 (ASCENT) NCT02574455 Phase III Study of Sacituzumab Govitecan (IMMU132) in Refractory/Relapsed Triple-Negative Breast Cancer 3 Ferrario (JGH) Aline Mamo (JGH) Kriti Arora 23766 (JGH) THIRD LINE Must have been treated with a taxane MEASURABLE disease Coming soon 16 IMpassion130 MO39169 Roche NCT02425891 A Phase III, Multicenter, Randomized, PlaceboControlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer 3 Bouganim (MUHC) Penny Chipman (MUHC) Dianna Leroux Pager: 514-406-7410 FIRST LINE •No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC •MEASURABLE disease •No CNS mets 17 Novartis CR1615NS NCT02900664 Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with CJM112, EGF816, Ilaris® (canakinumab) or Mekinist® (trametinib) 1 Miller (JGH) Adele Cascini (JGH) Mahsid Mortazavi (JGH) 25981 SECOND LINE • MEASURABLE disease •Prior PD-1/PDL-1 inhibitors is allowed •No CNS mets 18 CR1618MK KEYNOTE 355 NCT02819518 A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer 3 Ferrario (JGH) Adele Cascini (JGH) Sheila Rincon 24624 (JGH) FIRST LINE •TNBC (
           
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