1 / 11

IBCSG 22-00: Objective

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.

blondelle-kayson
Download Presentation

IBCSG 22-00: Objective

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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.

  2. IBCSG 22-00:Angiogenesis inhibition for pre and postmenopausal hormone non-responsive tumors S U R G E R Y Induction CT Randomize before induction CT or any time prior to day 56 of last induction CT cycle A • Stratify • Menop.status • Institution • Induction CT B ≦ 8 weeks Induction CT CM x 12 months

  3. 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

  4. IBCSG 22-00:Eligibility

  5. 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

  6. IBCSG 22-00:Concomitant treatments • Radiotherapy to the conserved breast is mandatory • Herceptin for Her2+ disease is allowed

  7. 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.*

  8. 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

  9. IBCSG 22-00:CRF completion • Documentation: • 3 part paper CRF‘s Submit white original and yellow copy

  10. IBCSG 22-00:QL timepoints Revised per amendment 4

  11. IBCSG 22-00:Forms completionAE form • No AE forms during induction CT • 1 AE form per CMM form • Submit every 3 months

More Related