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International Collaborative Cancer Group (ICCG)

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 International Collaborative Cancer Group (ICCG). Clinical trials include:

  1. Epirubicin plus tamoxifen versus tamoxifen alone in postmenopausal node-positive primary breast cancer. C/4/87

  2. Adjuvant cyclophosphamide methotrexate and 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in premenopausal node-positive primary breast cancer. (CMF/FEC N+). C/2/84

  3. Adjuvant cyclophosphamide, methotrexate and 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in women with node-negative, poor-risk primary breast cancer. C/6/89

  4. Adjuvant FEC50 versus FEC75 with or without the additional benefit of sequential hormone therapy (HT) in node-positive premenopausal primary breast cancer. C/9/91

  5. High-dose therapy with PBCS support in primary breast cancer. C/10/92 – C/32/96

  6. Randomized double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for 2–3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen. BIG 02-97/Study No. 96 OEXE 031-C/13/96

  7. A multicentre-randomized trial of sequential epirubicin and docetaxel versus epirubicin in node-positive postmenopausal breast cancer patients. C/14/96

  8. A phase III multicentre double-blind randomized trial of celecoxib versus placebo in primary breast cancer patients. An intergroup study from the International Collaborative Cancer Group and the German Breast Group (GBG). BIG 1-03 – ICCG/C/20/01 – GBG 27

ICCG – Contact Details

Country

Europe, South America

Chair

P. Hupperets, University Hospital Maastricht, Internal Medicine, Haematology / Oncology, Postbus 5800, 6202 AZ Maastricht, THE NETHERLANDS. Tel: +31 43 387 7025 Fax: +31 43 387 5006 Email:

Data Center

ICCG Data Centre – Oncology, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics, Faculty of Medicine, Imperial College London, Charing Cross Campus, London, W6 8RF, UNITED KINGDOM. Tel: +44 208 741 0648 Fax: +44 208 741 0731 Email:

ICCG – Study Details

Title

Epirubicin plus tamoxifen versus tamoxifen alone in postmenopausal node-positive primary breast cancer.

C/4/87

Coordinator(s)

Dr J. Wils, St Laurentius Ziekenhuis, NL-6043 CV ROERMOND, THE NETHERLANDS. Tel: +31 475 38 24 66 Fax: +31 475 38 24 36

Summary

  • Closed in April 1998 (opened in September 1989)
  • Target accrual: 694 patients

Objectives

  • Disease-free survival.
  • Survival.

Scheme

Update

  • Study closed April 1998; 648 patients randomized. Long-term follow-up ongoing.

Related Publications

Wils JA, Bliss JM, Marty M et al. Epirubicin plus tamoxifen versus tamoxifen alone in node positive postmenopausal patients with breast cancer: a randomized trial of the International Collaborative Cancer Group (ICCG). J Clin Oncol 1999; 17: 1–11.

Topics

  • Anthracyclines
  • Tamoxifen
  • Node-positive breast cancer
  • Postmenopausal patients

Keywords

Adjuvant, anthracyclines, tamoxifen, node-positive breast cancer, postmenopausal

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

Title

Adjuvant cyclophosphamide methotrexate and 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in premenopausal node-positive primary breast cancer. (CMF/FEC N+)

C/2/84

Coordinator(s)

Professor M. Marty, Centre des Innovations Thérapeutiques en Oncologie et Hématologie, Centre Hospitalier Universitaire Saint Louis, 1 Avenue Claude Vellefaux, 75475 PARIS Cedex 10, FRANCE. Tel: +33 1 42 49 48 10 Fax: +33 1 42 49 48 11

Professor R.C. Coombes, Imperial College London, Department of Cancer Medicine, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics, MRC Cyclotron Building, Hammersmith Hospital Campus, LONDON W12 ONN, UNITED KINGDOM. Tel: +44 208 383 5828 Fax: +44 208 383 5830

Summary

  • First patient randomized: 1984

Objective

  • The primary aim of this study was to compare disease-free survival and overall survival in patients treated with CMF, with that observed in patients treated with FEC.

The study had two randomization schedules: CMF1/FEC1 (Non French centres) or CMF2/FEC2 (French Centres).

Scheme

Update

  • Study Status: Closed 1992. Active follow-up continues.
  • Number of patients accrued: 759.

Related Publications

Coombes RC, Bliss JM, Wils J et al. for the International Collaborative Cancer Group (ICCG). Adjuvant cyclophosphamide, methotrexate, 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin, cyclophosphamide (FEC) chemotherapy in premenopausal women with axillary node positive operable breast cancer: results of a randomised trial. J Clin Oncol 1996; 14: 35–45.

Topics

  • Node-positive breast cancer
  • Premenopausal patients

Keywords

Adjuvant, node-positive breast cancer, chemotherapy, premenopausal

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

Title

Adjuvant cyclophosphamide, methotrexate and 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in women with node-negative, poor-risk primary breast cancer.

C/6/89

Coordinator(s)

Professor M. Marty, Centre des Innovations Thérapeutiques en Oncologie et Hématologie, Centre Hospitalier Universitaire Saint Louis, 1 Avenue Claude Vellefaux, 75475 PARIS Cedex 10, FRANCE. Tel: +33 1 42 49 48 10 Fax: +33 1 42 49 48 11

Summary

  • Opened in February 1990
  • Target accrual: no target accrual but interim analysis after 600 patients

Objectives

  • Disease-free survival.
  • Overall survival.

Scheme

Update

  • Study closed to recruitment on 1 August 2000.
  • Number of patients accrued: 950.
  • Active follow-up continues.

Related Publications

None available

Topics

  • Node-negative breast cancer

Keywords

Adjuvant, node-negative breast cancer, chemotherapy

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

Title

Adjuvant FEC50 versus FEC75 with or without the additional benefit of sequential hormone therapy (HT) in node-positive premenopausal primary breast cancer.

C/9/91

Coordinator(s)

Professor M. Marty, Centre des Innovations Thérapeutiques en Oncologie et Hématologie, Centre Hospitalier Universitaire Saint Louis, 1 Avenue Claude Vellefaux, 75475 PARIS Cedex 10, FRANCE. Tel: +33 1 42 49 48 10 Fax: +33 1 42 49 48 11

Summary

  • Opened in March 1992
  • Target accrual: 720 patients

Objectives

  • Disease-free survival.
  • Overall survival.

Scheme

Update

  • Study closed to recruitment on 1 August 2000.
  • Number of patients accrued: 785.
  • Active follow-up continues.

Related Publications

None available

Topics

  • Node-positive breast cancer
  • Premenopausal patients
  • Hormonal therapy

Keywords

Adjuvant, chemotherapy, node-positive breast cancer, premenopausal, hormonal therapy

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

Title

High-dose therapy with PBCS support in primary breast cancer.

C/10/92 – C/32/96

Coordinator(s)

Professor R.C. Coombes, Imperial College London, Department of Cancer Medicine, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics, Faculty of Medicine, MRC Cyclotron Building, Hammersmith Hospital Campus, LONDON W12 ONN, UNITED KINGDOM. Tel: +44 208 383 5828 Fax: +44 208 383 5830 Email:

Summary

  • Opened in July 1993
  • Target accrual: 230 patients

Objectives

  • Disease-free survival.
  • Overall survival.

Scheme

Update

  • Study closed to recruitment on 28 September 2001.
  • Number of patients accrued: 281.
  • Active follow-up continues.

Related Publications

Coombes RC, Bliss JM, Howell A et al., on behalf of the International Collaborative Cancer Group. High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an International Randomised Trial. Ann Oncol 2005; 16(5): 726–734.

Topics

  • High-dose chemotherapy
  • Node-positive breast cancer

Keywords

Adjuvant, high dose chemotherapy, node-positive breast cancer

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

Title

Randomized double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for 2–3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen.

BIG 2-97/C/13/96

Coordinator(s)

Professor R.C. Coombes, Imperial College London, Department of Cancer Medicine, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics, Faculty of Medicine, MRC Cyclotron Building, Hammersmith Hospital Campus, LONDON W12 ONN, UNITED KINGDOM. Tel: +44 208 383 5828 Fax: +44 208 383 5830 Email:

Summary

  • Opened in February 1998
  • Target accrual: 1103 patients/arm

Objectives

  • To evaluate disease-free survival and overall survival in ER + or unknown breast cancer patients treated either with tamoxifen or with exemestane after having received adjuvant tamoxifen for 2–3 years.
  • To evaluate the incidence of contralateral breast cancer and the general long-term tolerability of the regimens.
  • To evaluate the tolerability of each regimen in terms of endometrial status, bone metabolism, lipid profile, coagulation profile and quality of life.

Scheme

Quality of Life sub-Protocol

A study to compare the quality of life of those patients allocated to tamoxifen with those allocated to exemestane, with the aim of determining efficacy, toxicity and overall general health and well being. (continued)

Endometrial Sub-Protocol

A study to assess endometrial ultrasound changes in postmenopausal patients receiving exemestane after 2–3 years of adjuvant tamoxifen compared to patients continuing on tamoxifen.

Bone Sub-Protocol

To compare bone mineral density (BMD) and metabolism in patients receiving exemestane with those receiving tamoxifen.

Update

  • The main study closed to recruitment on 28 February 2003.

4740 patients recruited.

  • Quality of Life Study – Closed to recruitment on 31 December 2001.

581 patients recruited.

  • Endometrial Study – Closed to recruitment on 31 August 2001.

219 patients recruited.

  • Bone Study – Closed to recruitment on 28 February 2003.

206 patients recruited.

Related Publications

Coombes RC et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. New Engl J Med 2004; 350: 1081–1092.

Fallowfield L et al. Quality of Life in the Intergroup Exemestane Study: A randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol 2006; 24: 910–917.

Topics

  • Tamoxifen
  • Aromatase inhibitors
  • Postmenopausal patients

Keywords

Adjuvant, endocrine therapy, tamoxifen, aromatase inhibitors, postmenopausal

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

Title

A multicentre-randomized trial of sequential epirubicin and docetaxel versus epirubicin in node-positive postmenopausal breast cancer patients.

C/14/96

Coordinator(s)

Dr F. Erdkamp, Maaslandziekenhuis, Internal Medicine, Postbus 5500, NL-6130 MB SITTARD, THE NETHERLANDS. Tel: +31 46 459 7896 Fax: +31 46 459 7983

Dr P.J. Hupperets, University Hospital Maastricht, Department of Internal Medicine, Division of Haematology–Oncology, P.O. Box 5800, NL-6202 AZ MAASTRICHT, THE NETHERLANDS. Tel: +31 43 387 7025 Fax: +31 43 387 5006 Email:

Professor R.C. Coombes, Imperial College London, Department of Cancer Medicine, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics, Faculty of Medicine, MRC Cyclotron Building, Hammersmith Hospital Campus, LONDON W12 ONN, UNITED KINGDOM. Tel: +44 208 383 5828 Fax: +44 208 383 5830

Summary(s)

  • Opened in August 1997
  • Target accrual: 800 patients

Primary Objectives

  • Disease-free survival.
  • Overall survival.

Secondary Objective

  • Incidence of thromboembolic events (selected centers).

Scheme

Update

  • Study closed to recruitment in August 2005.
  • Number of patients accrued: 804.
  • Active follow-up continues.

Related Publications

None available

Topics

  • Postmenopausal
  • Anthracyclines
  • Taxanes
  • Tamoxifen
  • Node-positive breast cancer

Keywords

Adjuvant, postmenopausal, chemotherapy, anthracyclines, taxanes, tamoxifen, node-positive breast cancer

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

Title

A phase III multicentre double-blind randomized trial of celecoxib versus placebo in primary breast cancer patients. An intergroup study from the International Collaborative Cancer Group and the German Breast Group (GBG).

BIG 1-03 – ICCG/C/20/01 – GBG 27

(see also study description under GBG)

Coordinator(s)

Professor R.C. Coombes, Imperial College London, Department of Cancer Medicine, Division of Surgery, Oncology, Reproductive Biology and Anaesthetics, Faculty of Medicine, MRC Cyclotron Building, Hammersmith Hospital Campus, LONDON W12 ONN, UNITED KINGDOM. Tel: +44 208 383 5828 Fax: +44 208 383 5830

Professor Dr med Gunter von Minckwitz, German Breast Group, GBG Forschungsgesellschaft mbH, Schleussner Strasse 42, 63263 NEU ISENBURG, GERMANY. Tel: +49 6102 798740 Fax: +49 6102 7987440

Dr P.J. Hupperets, University Hospital Maastricht, Department of Internal Medicine, Division of Haematology–Oncology, P.O. Box 5800, NL-6202 AZ MAASTRICHT, THE NETHERLANDS. Tel: +31 43 387 7025 Fax: +31 43 387 5006

Summary

  • Study due to open in October 2006
  • Target accrual: 2590 patients

Primary Objective

  • To assess the disease-free survival (DFS) benefit of 2 years adjuvant therapy with the COX-2 inhibitor celecoxib compared with placebo in primary breast cancer patients.

Secondary Objectives

  • To compare overall survival.
  • To define the safety of adjuvant therapy with celecoxib in this patient population.
  • To assess the DFS benefit of 2 years adjuvant celecoxib compared with placebo in hormone receptor (HR) positive disease.
  • To compare the incidence of second primary breast cancers.
  • In postmenopausal HR positive patients, to assess the tolerability of celecoxib with tamoxifen.
  • To assess DFS benefit of 2 years adjuvant celecoxib compared with placebo in HR positive and in HR negative disease.

Scheme

Update

  • Study will begin recruitment in October 2006.

Related Publications

None available

Topics

  • Aromatase inhibitors
  • Celecoxib
  • Tamoxifen

Keywords

Adjuvant, COX-2 inhibitors, aromatase inhibitors, tamoxifen