The IBCSG

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The IBCSG

• August 2007

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History of IBCSG
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History of IBCSG

• In January 1976, Dr Jan Stjernswärd invited
• Kurt Brunner, John Forbes, Percy Helman,
  Carl-Magnus Rudenstam, Ken Stanley, Martin
  Tattersall, John Simpson and Marvin Zelen
• Soon joined by
• Alan Coates, John Collins, Franco Cavalli, Jurij
  Lindtner, Ian Russel, Hans-Jörg Senn, Aron
  Goldhirsch Rich Gelber

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History of IBCSG
In 1976 an enthusiastic researcher, Dr Jan
Stjernswärd, invited a group of friends to create
an international collaborative group dedicated to
clinical research

• ? The Ludwig Breast Cancer Study Group (LBCSG)
  was founded in 1977

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The Goals of IBCSG
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Goals

• The IBCSG conducts academic trials in early
  breast cancer
• The IBCSG is dedicated to innovative clinical
  cancer research designed to improve the outcome
  of women with breast cancer
• The IBCSG has been and continues to be a pioneer
  in research into combined hormonal therapy and
  chemotherapy, timing and duration of adjuvant
  therapies and quality of life of breast cancer
  patients.

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The Structure and Organization of IBCSG
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IBCSG The Organization

• Foundation under Swiss law
• Foundation Council
• (President Prof. Beat Thürlimann)
• Scientific Committee
• (Co-Chairs Prof. Aron Goldhirsch and Prof. Alan
  Coates)
• CEO (Prof. Monica Castiglione)

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IBCSG The Structure

• Participants all over the world
• Coordinating Center, Bern
• Data Management Center, Amherst
• Statistical Center, Boston
• Pathology office, Milan Glasgow
• Quality of Life office, Bern
• Data Safety Monitoring Committee
• IBCSG Ethics Committee

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Global cooperation
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A worldwide collaboration
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A worldwide collaboration

• Australia
• Belgium
• Brazil
• Canada
• Chile
• Hungary

• Russia
• Slovenia
• South Africa
• Spain
• Sweden
• Switzerland
• United Kingdom

• India
• Italy
• New Zealand
• Nigeria
• Peru
• Romania

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IBCSG What is special?

• The red line of research questions
• Investigation of long-term biological principles
• Quality control by long-term follow-up
• Logistical and high intellectual visibility

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IBCSG Strengths

• High quality clinical research
• Data manager and medical review of each case
• Auditing
• Institution evaluation
• Safety control SAE reporting
• Pathology
• central review 10_Pathology material
  submission.ppt
• Banking
• Pioneer work in Quality of Life questions

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Accrual
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Some numbers
1000 new patients per year gt 22000 patients
entered overall gt 15000 patients in follow up
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Entry and Follow-up through 2006
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Publications
The IBCSG published 187 papers up to June 19,
2007. 21 studies are published
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Clinical Trials
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Open studies
IBCSG 22-00 IBCSG 23-01 IBCSG 24-02
 SOFT  IBCSG 25-02  TEXT  IBCSG 27-02 IBCSG
29-03 IBCSG 31-03  IBIS II  IBCSG 32-05
 CASA  IBCSG 33-03 IBCSG 34-05 (SWOG
0230) IBCSG 35-07  SOLE  IBCSG 36/37-07
 (Neo)ALTTO 
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IBCSG 22-00Trial22 .ppt
Endocrine Non-Responsive Disease
After definitive surgery but within 56 days
after the first day of the last cycle of
induction CT
RANDOMIZE
Strata
CT CT ? CM x 12 mos. Approved Induction CT
Regimens
Menopausal Status Type of CT Institution
Study Chair Marco Colleoni
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IBCSG 23-01

• Patients with clinically node negative breast
  cancer (lt 3 cm) and micrometastases (lt 2 mm) in
  the sentinel node

Axillary Dissection vs. No Axillary Dissection
Study Chair Viviana Galimberti
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IBCSG 23-01Sentinel lymph node Trial
Negative No further surgery No further
surgery Micro lt 2mm Axillary
dissection Micro gt 2mm Axillary dissection

Random
Sentinel Node Biopsy
T lt 3 cm N0 M0
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IBCSG 23-01 Status

• Activated for EIO April 2001
• Group activation December, 2001
• Amendment 1 September, 2002
• Amendment 2 June 2007
• Accrual (30June2007) 590
• Target 1960

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Tailored Treatment InvestigationsIBCSG 24-02,
25-02, 26-02

• Global Participation
• BIG and North American Intergroup and

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Tailored Treatment Investigations

• Premenopausal patients with endocrine-responsive
  disease (ER gt 10 and/or PgR gt 10)

24-02 Suppression of Ovarian Function Trial
(SOFT) 25-02 Tamoxifen and Exemestane Trial (TEXT)
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IBCSG 27-02 (BIG 1-02)

• Adjuvant Chemotherapy for Radically Resected
  Loco-Regional Relapse

Strata
R ANDOMIZE
S URGERY
Observation /- RT(?HT for HR)) CT /- RT
(?HT for HR)
-Prior CT -ER and/or PgR -Location of
recurrence
CTchemotherapy HThormone therapy
RTradiotherapy HRER and/or PgR
Study Chair Stefan Aebi
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IBCSG 27-02 (BIG 1-02)

• Final protocol approved by Ethical Committee
  March, 2002
• Activated July 2002
• Accrual by 30.June2007 99
• Targeted accrual 1960

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IBCSG 29-03 (BIG 03-98)

• A Survey to assess the attitude of patients aged
  less than 35 years, with early breast cancer,
  towards the risk of loss of fertility related to
  adjuvant therapies

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IBCSG Trial 32-05/BIG 1-05 Chemotherapy Adjuvant
Studies for women at advanced Age (CASA)

• Phase III Trials Evaluating the Role of Adjuvant
  Caelyx for Women (age 66 years or older) with
  Endocrine Nonresponsive Breast Cancer Who Are NOT
  Suitable for being offered a Standard
  Chemotherapy Regimen

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IBCSG 33-03
A randomized controlled trial of a consultation
skills training package for doctors , concerning
communication of oncologists about standard
treatment options and clinical trials with
patients with early breast cancer.
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IBCSG 34-05 (SWOG 0204)LHRH Analog during
chemotherapy to reduce ovarian failure

• premenopausal women (age gt18 - lt 50)
• receptor negative, completely resected
• pT1-pT3 pSN0, pN0-pN2 M0
• Adjuvant or neoadjuvant CT planned RT allowed
• Rando within 84 days after final surgery
• Target accrual 416 patients over 3 years

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IBCSG 34-05 (SWOG 0204)

• Stratify
• Age lt40 vs. 40 49)
• Chemotherapy regimen- 4 cycle anthracycline
  based vs.- 6 8 cycle anthracyclinebased
  vs.- 6 8 cycle nonanthracycline based

R A N D O M I Z E
Standard CT
Goserelin (Zoladex) plus standard CT
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IBCSG 35-07
A phase III trial evaluating the role of
continuous letrozole versus intermittent
letrozole following 4 to 6 years of prior
adjuvant endocrine therapy for postmenopausal
women with hormone-receptor positive,
node-positive early stage breast cancer.
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IBCSG 36-07/BIG2-06 (ALTTO )
Centrally-determined HER2
Design 1 Without Taxane
LVEF ? 50
Radiotherapy as indicated concomitant with HER2
directed therapies
RANDOMIZATION
Lapatinib1 yr
3-weeklytrastuzumab
Lapatinib3-weeklytrastuzumab
Trastuzumab Weekly 12 weeks
6 weeks break
lapatinib7.5 mo
1 year
M Piccart, EA Perez
mainly out of TBCI sites
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THANK YOU!