IBCSG 22-00: Objective

To evaluate the efficacy of a low-dose chemotherapy regimen, hypothesized to have anti-angiogenic activity, administered following a standard chemotherapy program, in patients whose tumors are not endocrine therapy-responsive.

IBCSG 22-00: Angiogenesis inhibition for pre and

postmenopausal hormone non-responsive tumors

Stratify•Menop.status•Institution•Induction CT

SURGERY

Randomizebefore induction CT or any time prior to day 56 of last induction CT cycle≦ 8 weeks

A

B

Induction CT

Induction CT CM x 12 months

IBCSG 22-00: Eligibility

• Pre- or postmenopausal• ER- and PgR receptors negative (<10%)• Resection margins free of tumor• Axillary staging performed• SNB positive: axillary dissection done• SNB micrometastasis only: randomize to

trial 23-01

IBCSG 22-00: Eligibility

IBCSG 22-00: approved induction regimens

• AC/EC x 4• CMF x 6• AC/EC x 4 followed by CMF x 3 or T x 4• CEF/CAF 1,8 x 6• FEC 100• Iv FAC x 6• A x 4 followed by iv CMF x 4• Dose dense ACT x 4• FEC100 x 3 followed by T x 3• TAC x 6• A x 3 followed by T x 3 followed by classical CMF x 3

IBCSG 22-00: Concomitant treatments

• Radiotherapy to the conserved breast is mandatory

• Herceptin for Her2+ disease is allowed

IBCSG 22-00: Randomization 1

• Verify eligibility.• Obtain written informed consent• Complete Confirmation of Registration

Form (A). • Complete the pre-randomization Quality

of Life (QL) core and module forms. • Telephone or fax your Randomization

Center.*

IBCSG 22-00: Randomization 2

• All GOCCHI investigators will contact the GOCCHI Coordinating Center to randomize patients:

• Phone: 56-2-2330798Fax: 56-2-2310983Email: datacenter@gocchi.cl

IBCSG 22-00: CRF completion

• Documentation:• 3 part paper CRF‘s

Submit white original and yellow copy

IBCSG 22-00: QL timepointsRevised per amendment 4

IBCSG 22-00: Forms completion

AE form• No AE forms during induction

CT• 1 AE form per CMM form• Submit every 3 months