The IBCSG
August 2007
History of IBCSG
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
History of IBCSG
The Ludwig Breast Cancer Study Group (LBCSG) was
founded in 1977
In 1976 an enthusiastic researcher, Dr Jan Stjernswärd, invited a group of friends to
create an international collaborative group dedicated to clinical research…
The Goals of IBCSG
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.
The Structure and Organization of IBCSG
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)
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
Global cooperation
A worldwide collaboration
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
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
• 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
IBCSG Strengths
Accrual
Some numbers
~ 1’000 new patients per year
> 22’000 patients entered overall
> 15’000 patients in follow up
Entry and Follow-up through 2006
0
2000
4000
6000
8000
10000
12000
14000
16000
78 80 82 84 86 88 90 92 94 96 98 00 02 04 6
Entry
Follow-Up
Publications
The IBCSG published 187 papers up to June 19, 2007.
21 studies are published
Clinical Trials
Open studies
IBCSG 22-00 IBCSG 23-01 IBCSG 24-02 »SOFT »IBCSG 25-02 « TEXT »IBCSG 27-02IBCSG 29-03IBCSG 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 »
IBCSG 22-00Trial22 .ppt
Endocrine Non-Responsive Disease
Strata
MenopausalStatus
Type of CT
Institution
After definitive surgery but within 56 days after the first day of the last cycle of induction CT
CT*
CT* CM x 12 mos.
*Approved Induction CT Regimens
RANDOMIZE
Study Chair: Marco Colleoni
IBCSG 23-01
Patients with clinically node negative breast cancer (< 3 cm) and
micrometastases (< 2 mm) in the sentinel node
Axillary Dissection vs.No Axillary Dissection
Study Chair: Viviana Galimberti
IBCSG 23-01:Sentinel lymph node Trial
SentinelSentinelNodeNodeBiopsyBiopsy
NegativeNegative No further surgeryNo further surgery
No further surgeryNo further surgeryMicro Micro << 2mm 2mm
Axillary dissectionAxillary dissection
Micro > 2mmMicro > 2mm Axillary Axillary dissectiondissection
RandomRandom
T < 3 cmT < 3 cmNN00 M M00
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
Tailored Treatment Investigations
IBCSG 24-02, 25-02, 26-02
Global Participation:BIG and North American Intergroup
and …
Tailored Treatment Investigations
Premenopausal patients with endocrine-responsive disease (ER >
10% and/or PgR > 10%) 24-02 Suppression of Ovarian Function Trial (SOFT)
25-02 Tamoxifen and Exemestane Trial (TEXT)
IBCSG 27-02 (BIG 1-02)Adjuvant Chemotherapy for Radically
Resected Loco-Regional Relapse
Observation +/- RT(HT for HR+)+)
CT +/- RT (HT for HR+)
CT=chemotherapy; HT=hormone therapy; RT=radiotherapyHR+=ER+ and/or PgR+
RANDOMIZE
SU
R
G
ER
YStudy Chair: Stefan Aebi
Strata
-Prior CT-ER+ and/or PgR+-Location of recurrence
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
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
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”
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.
IBCSG 34-05 (SWOG 0204)LHRH Analog during chemotherapy to
reduce ovarian failure
•premenopausal women (age >18 - < 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
IBCSG 34-05 (SWOG 0204)
RANDOMIZE
Standard CT
Goserelin (Zoladex) plus standard CT
Stratify:•Age <40 vs. 40 – 49)•Chemotherapy regimen:- 4 cycle anthracycline based vs.- 6 – 8 cycle anthracyclinebased vs.- 6 – 8 cycle nonanthracycline based
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.
IBCSG 35-07 S LE
RANDOMIZATION
Design 1 Without Taxane* LVEF 50
M Piccart, EA Perez*mainly out of TBCI sites
Radiotherapy as indicated concomitant with HER2 directed therapies
Lapatinib1 yr
TrastuzumabWeekly
12 weeks
lapatinib
7.5 mo
3-weeklytrastuzumab
Lapatinib+
3-weeklytrastuzumab
1 ye
ar
6 weeks break
IBCSG 36-07/BIG2-06 (ALTTO )
HER2+ invasive breast cancerHER2+ invasive breast cancer
Surgery, complete (neo)adjuvant anthracycline-based chemotherapySurgery, complete (neo)adjuvant anthracycline-based chemotherapyCentrally-determined HER2+Centrally-determined HER2+