Study of Adjuvant Kadcyla vs Herceptin, HER2+ve Primary Breast Cancer

• Research type

  Research Study

• Full title

  A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2 POSITIVE PRIMARY BREAST CANCER

• IRAS ID

  120959

• Contact name

  Mark Verrill

• Contact email

  mark.verrill@doctors.org.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2012-004902-82

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Summary of Research
  The purpose of this study is to compare the effects, good or bad, of trastuzumab emtansine plus pertuzumab, following anthracycline chemotherapy versus trastuzumab plus pertuzumab plus taxane, following anthracycline chemotherapy to find out which is better to delay or prevent breast cancer from returning with more or less side effects.

  Trastuzumab (Herceptin®), an anti-HER2 drug, is approved in multiple countries for the postsurgery treatment of patients with HER2-positive breast cancer to reduce the risk of the cancer returning.

  Pertuzumab (Perjeta(TM)), targets HER2 at a different site than trastuzumab so that these 2 drugs can act together in complementary ways.

  Trastuzumab emtansine (Kadcyla(TM)) is composed of a chemotherapy agent (DM1) linked to Herceptin(TM) (trastuzumab). Thus DM1 is supposed to only target HER2 positive cancer cells and not normal cells. Therefore, trastuzumab emtansine is anticipated to provide effects from trastuzumab and attached chemotherapy agent DM1 without causing side effects that are usually seen with conventional chemotherapy. With newer anti-HER2 drugs such as trastuzumab emtansine and pertuzumab, the risk of such cancer returning may be further reduced with tolerable side effects.

  This study has been designed to investigate the efficacy and safety of combining pertuzumab with trastuzumab and standard approved chemotherapy regimens as treatment for patients with HER2 over expressing early breast cancer.

  The planned, maximum, targeted treatment period is 52 weeks. Once this is complete all patients will continue to befollowed up until approximately 10 years after the randomisation date of the last patient.

  Approximately 2,500 patients will take part in the study from all over the world.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdpw6TtlYa71Mc4BCDRAmGJJasVA5jnC5t-2BK7x5CIToEPlP57UuidV-2F0BD3zL4RejPmWg9Rb4XxpswGj0Z9KB0iecG05u0dss7W2JPE-2BqJK0Tc-3DsEkm_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKjXYjKCEUA2Fb7OwmR2eCjEVFWXWM-2BG38O4bs4WW2Th4WZmdxxF-2F-2FdjYpcESiN1SzpsmJcbJRwYfFb6CGLF2ckKpTqzpJq2HVWoG0hFTJ1zfCFIg6g9jpFyzY0KouQ-2BV-2BaOoieG03api6gt4LspX1YStnWxbK1FdJOVxkuRujZtg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C60692cff19a342243db208da43bfbafe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637896787999481724%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=CUjvPaLMmRVnRzNz31pMcZ6rrQZjSQDwuDQthRpQMwA%3D&reserved=0

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  13/EM/0460

• Date of REC Opinion

  7 Jan 2014

• REC opinion

  Further Information Favourable Opinion