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+