scholarly journals National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 373-401
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Postmenopausal Women ◽  
Primary Breast Cancer ◽  
Randomized Study ◽  
Phase Iii ◽  
Adjuvant Tamoxifen ◽  
Double Blind ◽  
Node Negative ◽  
Increased Risk

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG). Clinical trials include: Double-blind randomized trial of tamoxifen versus placebo in patients with node-positive or high-risk node-negative (tumor ≥ 1 cm and either higher histological grade (poorly differentiated, or SBR grade III or MSBR grade V) or lymphatic/vascular invasion or both) breast cancer who have completed CMF, CEF or AC adjuvant chemotherapy. NCIC CTG Trial MA.12A randomized trial of antiestrogen therapy versus combined antiestrogen and octreotide LAR therapy in the adjuvant treatment of breast cancer in postmenopausal women. NCIC CTG Trial MA.14A phase III randomized double blind study of letrozole versus placebo in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17NCIC CTG MA.17 Companion study (2): The influence of letrozole on bone mineral density in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC MA.17BNCIC CTG MA.17 Companion study (1): The influence of letrozole on serum lipid concentrations in women with primary breast cancer who have completed 5 years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17LNCIC CTG MA.17R A double blind re-randomization to letrozole or placebo for women completing 5 years of adjuvant letrozole in the MA.17 study.A phase III study of regional radiation therapy in early breast cancer. NCIC CTG trial MA.20A phase III adjuvant trial of sequenced EC + GCSF Taxol versus sequenced AC → Taxol versus CEF as therapy for premenopausal women and early postmenopausal women who have had potentially curative surgery for node positive or high-risk node negative breast cancer. NCIC CTG Trial MA.21A phase I/II study of increasing doses of epirubicin and docetaxel + pegfilgrastim for locally advanced or inflammatory breast cancer. NCIC CTG Trial MA.22A randomized phase III trial of exemestane versus anastrozole with or without celecoxib in postmenopausal women with receptor positive primary breast cancer. NCIC CTG Trial MA.27A randomized feasibility study of letrozole in postmenopausal women at increased risk for development of breast cancer as evidenced by high breast density. NCIC CTG Trial MAP.1A randomized study of the effect of exemestane (Aromasin) versus placebo on breast density in postmenopausal women at increased risk for development of breast cancer. NCIC CTG Trial: MAP.2A phase III randomized study of exemestane versus placebo in postmenopausal women at increased risk of developing breast cancer. NCIC CTG Trial: MAP.3

Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 212-222
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Randomized Study ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Node Positive ◽  
Positive Breast Cancer

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG). Clinical trials include: Standard CEF versus accelerated CEF as adjuvant chemotherapy in node-positive or high-risk node-negative (T > 2 cm, age <35 years, G3, negative hormone receptors or high TL1 or S-phase) breast cancer. A phase III randomized trial. MIG-1Epirubicin plus paclitaxel versus cyclophosphamide, epirubicin and 5-fluorouracil as adjuvant chemotherapy in node-positive breast cancer patients. A phase III randomized study. MIG-5A phase III randomized study of sequential epidoxorubicin plus cyclophosp-amide followed by docetaxel (EC D) versus a combination of 5-fluorouracil, epidoxorubicin and cyclophosp-amide (FEC) as adjuvant treatment of node-negative early breast cancer patients.A phase III randomized study of EC followed by paclitaxel versus FEC followed by paclitaxel, all given either every 3 or 2 weeks supported by pegfilgrastim, for node-positive breast cancer patients.Prevention of chemotherapy-induced menopause by temporary ovarian suppression with triptorelin versus control in young breast cancer patients. A randomized phase III multicenter study.Letrozole adjuvant therapy duration (lead) study: standard versus long treatment. A phase III trial in post-menopausal women with early breast cancer.

Results of ENCORE 301, a randomized, phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive (ER+) breast cancer progressing on a nonsteroidal aromatase inhibitor (AI).

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 268-268 ◽  
Author(s):  
D. A. Yardley ◽  
R. Ismail-Khan ◽  
P. Klein
Keyword(s):  
Breast Cancer ◽  
Postmenopausal Women ◽  
Hormonal Therapy ◽  
Stage Iv ◽  
Phase Iii ◽  
Controlled Study ◽  
Growth Factor Signaling ◽  
Intrinsic Resistance ◽  
Double Blind ◽  
The Impact

268 Background: Hormonal therapy, including AIs, is the mainstay of ER+ breast cancer (BC) treatment; however, both acquired and intrinsic resistance limits its clinical benefit. Entinostat is a novel, oral, class I selective histone deacetylase inhibitor that has been shown to inhibit growth factor signaling pathways that mediate AI resistance. This study was designed to evaluate the impact of the addition of entinostat to exemestane therapy on progression-free survival (PFS). Methods: Postmenopausal women with ER+ advanced BC who had progressed on a non-steroidal AI were randomized to exemestane 25 mg daily + entinostat 5 mg or placebo weekly. Results: A total of 130 women were enrolled (66 exemestane+placebo; 64 exemestane+entinostat). All but 1 patient had Stage IV disease, and 82% had measurable disease. All patients had received prior hormonal therapy (1 prior line 42%; >1 prior line 58%), and 62% had received prior chemotherapy (33% in the advanced BC setting). Analysis of the intent-to-treat population showed that PFS was significantly (defined prospectively as p <0.10) longer with exemestane+entinostat than with exemestane+placebo (4.28 versus 2.27 months, respectively; hazard ratio [HR] = 0.73; p=0.06). Entinostat combined with exemestane was well-tolerated with the most frequent adverse events (AEs) consisting of fatigue, gastrointestinal disturbances, and hematologic abnormalities. AEs with a ≥20% higher incidence with exemestane+entinostat than with exemestane+placebo were fatigue (46% versus 26%, respectively) and uncomplicated neutropenia (25% versus 0%, respectively). The serious AE rate was similar for exemestane+entinostat (13%) and exemestane+placebo (12%). Conclusions: Exemestane+entinostat significantly prolonged the median PFS and reduced the risk of disease progression by 27% versus exemestane+placebo (HR = 0.73). In light of these positive data, a phase III evaluation of this combination is planned.

Phase III trial of bisphosphonates as adjuvant therapy in primary breast cancer: SWOG/Alliance/ECOG-ACRIN/NCIC Clinical Trials Group/NRG Oncology study S0307.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 503-503 ◽  
Author(s):  
Julie Gralow ◽  
William E. Barlow ◽  
Alexander H. G. Paterson ◽  
Danika Lew ◽  
Alison Stopeck ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Adjuvant Therapy ◽  
Primary Breast Cancer ◽  
Phase Iii ◽  
Phase Iii Trial
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