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First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (TL) or their combination (L + T) in the adjuvant treatment of HER2-positive <br />early breast cancer (EBC) Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

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Page 1: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (TL) or their combination (L + T) in the adjuvant treatment of HER2-positive <br />early breast cancer (EBC)

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 2: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

TARGETING HER2 IN BREAST CANCER: EVOLVING CONCEPTS

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 3: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 3

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 4: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 4

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 5: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 5

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 6: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 6

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 7: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 7

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 8: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Primary Endpoint

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 9: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

SECONDARY EndpointS

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 10: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

STAtiStical considerations

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 11: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Current Analysis Plan

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 12: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 12

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 13: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

CONSORT TABLE

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 14: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 14

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 15: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Distribution of the Stratification Factors by Treatment Arm

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 16: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Distribution of patient characteristics by Treatment Arm

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 17: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 17

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 18: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

DISEASE-FREE SURVIVAL (DFS) ANALYSIS

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 19: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

DFS BY Hormone Receptor Status

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 20: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

DFS by Chemotherapy Timing

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 21: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

OVERALL SURVIVAL (OS) ANALYSIS

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 22: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

DFS NON-INFERIORITY ANALYSIS<br />Note: Null hypothesis hazard ratio is 1.11

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 23: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 23

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 24: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

PROPORTION OF PATIENTS RECEIVING ≥ 85% OF THE PLANNED DOSE OF ANTI-HER2 DRUGS

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 25: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Slide 25

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 26: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

MAIN DIFFERENCES IN AEs BY TREATMENT ARM

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 27: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

CARDIAC SAFETY

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 28: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

CONCLUSIONS (I)

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 29: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

CONCLUSIONS (II)

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting

Page 30: First results from the phase III ALTTO trial (BIG 02-06; NCCTG 063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone

Acknowledgements

Presented By Martine Piccart-Gebhart at 2014 ASCO Annual Meeting


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