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Scandinavian Breast Group (SBG)

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 Scandinavian Breast Group (SBG). Clinical trials include:

  1. High-dose chemotherapy + autologous stem cell transplantation compared with dose escalating chemotherapy in breast cancer with poor prognosis ≥ 8 positive lymph nodes or ≥ 5 lymph nodes combined with R-combined with either G II–III or high S-phase. A randomized study. SBG 9401

  2. Standard CEF-60 versus tailored CEF in high-risk primary breast cancer. SBG CEF-60, SBG 2000-1

  3. HABITS – Hormonal replacement therapy after breast cancer diagnosis – is it safe? BIG 03-97

  4. A phase II study continuing into a randomized phase III study comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel (dEC→T) or dose dense epirubicin + cyclophosphamide followed by docetaxel (EC→T) or docetaxel + doxorubicin + cyclophosphamide (TAC) in lymph node positive breast cancer patients. SBG 2004-1 STUDY

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. 430 - 438 , e76
Copyright
© 2006 Cambridge University Press

SBG – Contact Details

Country

Scandinavia

Chair

B. Ejlertsen, Department of Oncology 5012, Rigshospitalet, Blegdamsvej 9, DK-2100 COPENHAGEN, DENMARK. Tel: +45 35455088 Fax: +45 35456966 Email:

Website

www.roc.se

SBG – Study Details

Title

High-dose chemotherapy + autologous stem cell transplantation compared with dose escalating chemotherapy in breast cancer with poor prognosis ≥ 8 positive lymph nodes or ≥ 5 lymph nodes combined with R-combined with either G II–III or high S-phase. A randomized study.

SBG 9401

Coordinator(s)

J. Bergh, Radiumhemmet, Karolinska Institutet & University Hospital, S-17176 STOCKHOLM, SWEDEN. Tel: +46 8 51 77 62 79 Fax: +46 8 51 77 95 24 Email:

N. Wilking, Department of Oncology, Karolinska Institutet & University Hospital, S-17176 STOCKHOLM, SWEDEN. Tel: +46 87 29 43 09 Fax: +46 87 29 51 96

Summary

  • Closed in March 1998 (opened on 1 March 1994)
  • Target accrual: 500 patients

Objectives

  • To compare disease-free survival of high-risk breast cancer patients treated with either high-dose chemotherapy + autologous stem cell transplantation or dose-escalated chemotherapy (CEC) both as adjuvant treatment.
  • To compare survival, safety, dose-intensity and total dose between the two treatment arms.
  • To assess quality of life.

Scheme

Update

  • Study closed in March 1998.
  • 525 patients randomized.
  • Reported in The Lancet 2000.
  • New update 2003.
  • Final update 2008.

Related Publications

Brandberg Y, Michelson H, Nilsson B et al. Quality of life in women with breast cancer during the first year after random assignment to adjuvant treatment with marrow supported high-dose chemotherapy with cyclophosphamide, thiothepa, and carboplatin or tailored therapy with fluorouracil, epirubicin, and cyclophosphamide: Scandinavian Breast Group Study 9401. J Clin Oncol 2003; 21: 6359–3664.

Topics

  • High dose chemotherapy
  • Treatment tailoring

Keywords

Anthracyclines, high-dose therapy, node positive breast cancer

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

Title

Standard CEF-60 versus tailored CEF in high-risk primary breast cancer.

SBG CEF-60, SBG 2000-1

Coordinator(s)

C. Blomquist, Department of Oncology, Helsinki University Central Hospital, P.O. Box 180, 00029-HUCH, HELSINKI, FINLAND. Tel: +35 840 548 6580 Email:

M. Anderson, Department of Oncology 5074, Finsen Center Rigshospitalet, Blegdamsvej 9, DK-2100 COPENHAGEN, DENMARK. Tel: +45 35458105 Email:

J. Bergh, Radiumhemmet, Karolinska Institutet & University Hospital, S-17176 STOCKHOLM, SWEDEN. Tel: +46 8 51 77 62 79 Fax: +46 8 51 77 95 24 Email:

Summary

  • The study was open from February 2001 to August 2003. 1535 patients received the first course of standard FEC, accrual completed.
  • 1052 patients were randomized.

Objectives

  • To study whether retrospective observations indicating suboptimal effect of CT in patients not experiencing toxicity can be confirmed in a prospective study.
  • To study whether dose-escalation in patients not experiencing leukopenia improves prognosis.

Scheme

First cycle of CEF-60:

  • If WBG GR III/IV: continue with 6 cycles of CEF-60/reduced dose
  • If WBG GR 0–II: randomize to 6 cycles of CEF-60/escalated CEF

Update

  • First analysis based on event rate 2007/2008.

Related Publications

None available

Topics

  • Treatment tailoring

Keywords

Anthracycline, treatment tailoring, node negative breast cancer, node positive breast cancer

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

Title

HABITS – Hormonal replacement therapy after breast cancer diagnosis – is it safe?

BIG 03-97

Coordinator(s)

L. Holmberg, Regional Oncologic Center, University Hospital, S-75185 UPPSALA, SWEDEN. Tel: + 46 18 15 19 10 Fax: + 46 18 17 44 45 Email:

Summary

  • Opened in 1998, closed in December 2003 for safety reasons
  • Target accrual: 1300 patients

Objectives

  • To investigate in women with radically treated in situ, stage I or early stage II breast cancer if the use of hormone replacement therapy (HRT for menopausal symptoms) is safe concerning risk of breast cancer recurrence.
  • To look at quality of life and risk of breast cancer death.

Scheme

Update

  • At the end of accrual 434 women were randomized. After a medium follow-up of 2.1 years, 26 women in the HRT group and seven in the non-HRT group had a new breast cancer event, corresponding to a relative hazard for HRT treatment of 3.5 (95% confidence interval 1.5–8.1). During 2005 and 2006 a new monitoring round was completed and new analyses presented during autumn 2006.

Related Publications

Holmberg L, Anderson H, for the HABITS-steering and data monitoring committees. HABITS, a randomised comparison: trial stopped. Lancet 2004; 363: 453–455.

Topics

None available

Keywords

Breast cancer, menopausal symptoms, hormonal replacement therapy

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

Title

A phase II study continuing into a randomized phase III study comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel (dEC→T) or dose dense epirubicin + cyclophosphamide followed by docetaxel (EC→T) or docetaxel + doxorubicin + cyclophosphamide (TAC) in lymph node positive breast cancer patients.

SBG 2004-1 STUDY

Coordinator(s)

J. Bergh, Radiumhemmet, Karolinska Institutet & University Hospital, S-17176 STOCKHOLM, SWEDEN. Tel: +46 8 51 77 62 79 Fax: +46 8 51 77 95 24 Email:

Summary

  • First patient randomized in December 2004
  • Randomized feasibility study: Target accrual: 120 patients
  • Randomized phase III 2-armed study: 900 patients

Objectives

  • For the phase II part: evaluate safety and feasibility in the three treatment arms.
  • Evaluate the dose intensity in the three treatment arms.

For the Phase III Part:

Primary Objective

  • Compare breast cancer recurrence-free survival (BCRFS), in the dtEC→dtT (tailored doses) arm compared with the EC→T (fixed doses) arm.

Secondary Objectives

  • Compare distant disease free survival (DDFS).
  • Compare event-free survival (breast cancer relapse, contralateral breast cancer, other malignancies).
  • Compare overall survival (OS).

Additional aims/biological markers.

Scheme

Update

  • 120 patients entered on 8 May 2005.

Related Publications

None available

Topics

  • Dose densification

Keywords

Adjuvant chemotherapy, dose dense, node positive breast cancer, anthracyclins, taxanes