In Breast Cancer

CIRG focuses on pivotal strategies of development for new therapeutics.  Over 9,000 patients have been accrued into studies involving chemotherapy, hormonal therapy, supportive therapy, novel biologic agents, and translational research.

2nd analysis of CIRG/TORI 010 study was presented on December 11 at SABCS by Dr John Mackey from the Cross cancer Institute , abstract 47 CIRG/TORI 010: First Analysis of a Randomized Phase II Trial of Motesanib Plus Weekly Paclitaxel (P) as First Line Therapy in HER2-Negative Metastatic Breast Cancer (MBC).

= = =  = = > Click here to access to the official presentations available after the cut-of-dates.

>>> Click on the study number for more details <<<
 
 

Study

Description

Status

 

 

TRIO CIRG 019

A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Oral Everolimus (RAD001*) in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Recurrent or Metastatic Breast

Enrolling period

TRIO 018

Phase I/II Open Label, First Line Treatment of ER Positive, HER2 Negative Advanced Breast Cancer in Postmenopausal Women

Enrolling period

TRIO 017

 

Phase II, open-label trial of A HDACi in women with HER2 negative, locally-Recurrent or Metastatic Breast Cancer.

Enrolling period

TRIO-016

Phase II, open-label trial of HDACi in women with HER2 positive, locally-Recurrent or Metastatic Breast Cancer.

Enrolment closed

TRIO-CIRG 012

A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of Mab targeting VEGFR-2 Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer.

Enrolling period

BETH TRIO-CIRG 011

A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy
Plus Trastuzumab Plus Bevacizumab

Open to Enrollment (see press release

CIRG/TORI 010

Multicenter phase II randomized trial, Placebo Controlled AMG706 in Combination with Paclitaxel, or Open-Label Bevacizumab in Combination with Paclitaxel, as First Line Therapy in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Follow-up
1st analysis presented at ECCO-ESMO September 2009.

BCIRG 007

Randomized phase III trial comparing docetaxel and trastuzumab with trastuzumab, docetaxel and platinum salt (cisplatin or carboplatin) as first line chemotherapy for patients with advanced breast cancer containing the HER2neu alteration

Terminated.
1st analysis presented at ASCO and ESMO '06.  1st OS presented at ASCO '07.

BCIRG 006

Randomized phase III trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC->T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab
(AC->TH) and with docetaxel, platinum salt and trastuzumab (TCH) in the adjuvant treatment of node positive and high risk node negative patients with operable breast cancer containing the HER2neu alteration.

3rd analysis presented at SABCS 2009

BCIRG 005

Randomized phase III trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (AC->T) as adjuvant treatment of operable breast cancer HER2neu negative patients with positive axillary lymph nodes.

Efficacy results presented at SABCS 2008
Follow-up

BCIRG
103

Evaluation of molecular alterations that occur in human breast cancer tissue and normal skin after short term exposure to ZD1839 (IRESSAâ) at 250 mg/day and  correlation of these alterations with pharmacokinetic parameters .

Terminated

Final Results at SABCS 2005 poster 4079 
SABCS 2006 poster 1043

BCIRG 101 & 102

Phase II pilot studies of trastuzumab, docetaxel and platinum salt (cisplatin or carboplatin) as chemotherapy in advanced breast cancer patients with the HER2neu alteration.

Terminated
JNCI May 19, 04 96: 759-769

BCIRG 004

Randomized phase II double-blind comparison of Neupogen to the optimal schedule of SC-70935 in patients with breast cancer receiving chemotherapy with docetaxel, doxorubicin and cyclophosphamide (TAC).

Terminated. Published

BCIRG 002

Randomized phase III trial comparing 6 cycles of TAC to 4 cycles of TAC followed by MCV with APSCT in early breast cancer patients with 4 or more positive nodes.

Terminated

BCIRG 001

Randomized phase III trial comparing FAC to TAC in early breast cancer patients with positive nodes.

Follow-up

FDA Approval in 2004,
Publication:
NEJM vol 352:2302-2313, Jun 2, 005, ASCO '07