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Cancer International Research Group (CIRG)

Published online by Cambridge University Press:  04 December 2006

Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Cancer International Research Group (CIRG). Clinical trials include:

  1. A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (A → CT) as adjuvant treatment of operable breast cancer her2neu-negative patients with positive axillary lymph nodes.CIRG 005

  2. Multicenter phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) and with docetaxel, carboplatin and trastuzumab (TCH) in the adjuvant treatment of node-positive and high-risk node-negative patients with operable breast cancer containing the her2neu alteration. BCIRG 006.

  3. A multicenter phase III randomized trial comparing docetaxel (Taxotere) and trastuzumab (Herceptin) with docetaxel (Taxotere), platinum salt (cisplatin or carboplatin) and trastuzumab (Herceptin) as first line chemotherapy for patients with advanced breast cancer containing the her2neu alteration. BCIRG 007

Type
Other
Information
Breast Cancer Online , Volume 9 , Supplement S1: AN OVERVIEW OF RECENT AND ONGOING CLINICAL TRIALS FOR BREAST CANCER 4th EDITION , December 2006 , pp. 93 - 101 , e51
Copyright
© 2006 Cambridge University Press

CIRG – Contact Details

Countries

Canada, France, USA

Scientific Committee Chair

D. Slamon, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 10945 Le Conte Avenue, Suite 3360, Los Angeles, CA 90095, USA. Tel: +1 310 825 5193 Fax: +1 310 267 2301 Email:

CIRG Central Headquarters

Edmonton Office: Suite 1100, 9925-109 St., Edmonton, ALBERTA T5K 2J8, CANADA. Tel: +1 780 702 0200 Fax: +1 780 702 0190

CIRG Satellite Offices

Paris Office: 13, rue Martin Bernard, PARIS 75013, FRANCE. Tel: +33 1 58 10 09 09 Fax: +33 1 58 10 08 77 Email: (for all general inquiries and information)

Medical Officer

D. Slamon, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 10945 Le Conte Avenue, Suite 3360, Los Angeles, CA 90095, USA. Tel: +1 310 825 5193 Fax: +1 310 267 2301 Email:

Chief Operating Officer Executive

M.-A. Lindsay, Suite 1100, 9925-109 St., Edmonton, ALBERTA T5K 2J8, CANADA. Tel: +1 780 702 0223 Fax: +1 780 702 0190 Email:

Manager of Communications

E. Mékercke Tel: +33 1 58 10 08 97 Fax: +33 1 58 10 09 12 Email:

Website

www.cirg.org

CIRG – Study Details

Title

A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (A → CT) as adjuvant treatment of operable breast cancer her2neu-negative patients with positive axillary lymph nodes.

CIRG 005

Coordinator(s)

W. Eiermann, Red Cross Women Hospital, Fauenklinik vom Roten Kreuz, I Gyngebh. Abt./Taxisstr. 3, MUNCHEN 80637, GERMANY. Tel: +49 89 15 70 66 20 Fax: +49 89 15 70 66 23 Email:

J. Mackey, Northern Alberta Breast Cancer Program, Cross Cancer Institute, 11560 University Avenue, Edmonton, ALBERTA T6G 1Z2, CANADA. Tel: +1 780 432 8792 Fax: +1 780 432 8526 Email:

J. Crown, St Vincent Consulting Private Clinic, Herbert Avenue, Marian Road, DUBLIN 4, IRELAND. Tel: +353 1 209 4895 Fax: +353 1 283 7719 Email:

Summary

  • Start date: September 2000
  • Enrollment completed: February 2003
  • Final accrual: 3298 patients

Primary Objective

  • Disease-free survival.

Secondary Objective

  • Overall survival, toxicity and quality of life, pathologic and molecular markers, socioeconomics.

Scheme

Patient Population:

  • Node-positive
  • Adjuvant breast cancer
  • her2neu negative (centrally confirmed by FISH)

Randomization:

Stratify

  • Number of nodes (1–3, 4+)
  • Center

Update

  • The results of the first interim analysis were presented at the San Antonio Breast Cancer Symposium on December 2005, by Dr Eiermann (Poster Session #1069). The safety results were presented and are available on the SABCS and CIRG websites. Additional follow-up is required by the IDMC to evaluate the relative efficacy of combination versus sequential docetaxel-containing chemotherapy in the adjuvant treatment of women with node-positive, her2 breast cancer. Efficacy results will be presented at the final analysis planned Q1, 2008.

Related Publications

None available

Topics

  • her2-negative patients
  • Node-positive breast cancer
  • Taxanes

Keywords

Adjuvant, node-positive, her2 negative, docetaxel, sequential, combination of taxanes and anthracyclines

***************************************************

Title

Multicenter phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) and with docetaxel, carboplatin and trastuzumab (TCH) in the adjuvant treatment of node-positive and high-risk node-negative patients with operable breast cancer containing the her2neu alteration.

BCIRG 006.

Coordinator(s)

D. Slamon, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 10945 Le Conte Avenue, Suite 3360, Los Angeles, CA 90095, USA. Tel: +1 310 825 5193 Fax: +1 310 267 2301 Email:

J. Crown, St Vincent Consulting Private Clinic, Herbert Avenue, Marian Road, DUBLIN 4, IRELAND. Tel: +353 1 209 4895 Fax: +353 1 283 7719 Email:

Dr T. Pienkowski, Memorial Cancer Centre – Institute of Oncology, Breast Cancer Clinic, 5 Roentgena St., 02-781 WARSAW, POLAND. Tel: +48 22 644 0024 Fax: +48 22 644 0024 Email:

Summary

  • Enrollment start date: April 2001
  • Enrollment completed: March 2004
  • Final accrual: 3222 patients
  • Planned interim cardiac analyses after 300, 900 and 1500 patients have received chemotherapy treatment and 6 months follow-up.

Primary Objective

  • Disease-free survival.

Secondary Objective

  • Overall survival, toxicity and quality of life, pathologic and molecular markers, socioeconomics.

Scheme

Patient Population:

  • Node-positive
  • Adjuvant breast
  • High-risk node-negative
  • Her2neu positive (centrally confirmed by FISH in BCIRG laboratories)

Randomization:

Stratify

  • Number of nodes (0, 1–3, 4+)
  • Center

Update

  • The results from the first interim efficacy (at 322 events) and updated safety analyses were presented at the San Antonio Breast Cancer Symposium on December 2005, by Dr D. Slamon (Abstract #1) and are available on the CIRG website. Result of this trial confirms the benefit of Herceptin (H) when combined with docetaxel (AC-TH) or with docetaxel and carboplatin (TCH) without an anthracycline. There are fewer severe cardiac adverse events when H is administered without prior A. Longer follow-up is needed in order to confirm whether non-A-based adjuvant H regimens will have efficacy comparable to A-based regimens. Second interim analysis will present efficacy and safety results.

Related Publications

None available

Topics

  • Axillary lymph node dissection
  • Cardiac function
  • her2-positive patients
  • Node-negative breast cancer
  • Node-positive breast cancer
  • Sentinel node resection
  • Tamoxifen
  • Trastuzumab
  • Taxanes

Keywords

Adjuvant, HER2, Herceptin

***************************************************

Title

A multicenter phase III randomized trial comparing docetaxel (Taxotere) and trastuzumab (Herceptin) with docetaxel (Taxotere), platinum salt (cisplatin or carboplatin) and trastuzumab (Herceptin) as first line chemotherapy for patients with advanced breast cancer containing the her2neu alteration.

BCIRG 007

Coordinator(s)

J. Crown, St Vincent Consulting Private Clinic, Herbert Avenue, Marian Road, DUBLIN 4, IRELAND. Tel: +353 1 209 4895 Fax: +353 1 283 7719 Email:

V. Valero, University of Texas MD Anderson Cancer Ctr, 1515 Holcombe Blvd Unit 424, Houston, TX 77030-0056, USA. Tel: +1 713 792 2817 Fax: +1 713 794 4385 Email:

D. Slamon, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 10945 Le Conte Avenue, Suite 3360, Los Angeles, CA 90095, USA. Tel: +1 310 825 5193 Fax: +1 310 267 2301 Email:

Summary

  • Enrollment start date: December 2001
  • Enrollment completed: March 2004
  • Final accrual: 263 patients

Based on preclinical synergy seen between docetaxel (T), carboplatin (C) and trastuzumab (H), BCIRG conducted a randomized multicenter phase III trial in women with her2-positive MBC to evaluate the efficacy and safety of H regimens in combination with T or TC.

Primary Objective

  • Time to disease progression.

Secondary Objectives

  • To compare response rate, duration of response, overall survival.
  • To evaluate and compare clinical benefit, defined as CR, PR or stable disease >24 weeks.
  • To compare toxicity between the two arms.
  • To evaluate pathologic and molecular markers for predicting efficacy.
  • To compare peripheral levels of shed her2neu extracellular domain (ECD) with FISH determination in predicting outcome to treatment with Herceptin.

Scheme

Update

  • CIRG randomized 263 patients with her2 FISH + MBC; 131 patients were treated in each arm. Dr Forbes (from the trial ANZ BCTG group) presented results of safety and the TTP analysis conducted after 204 events at ASCO 2006. Additional information presented at ESMO (148PD)

Related Publications

None available

Topics

  • Cardiac function
  • her2-positive patients
  • Metastatic breast cancer
  • Taxanes
  • Trastuzumab

Keywords

MBC, trastuzumab, docetaxel