SafeHer: Safety study with subcutaneous trastuzumab in breast cancer

• Research type

  Research Study

• Full title

  A Phase III Prospective, Two-cohort, Non-randomized, Multi-centre, Multi-national, Open Label Study to Assess the Safety of Assisted- and Self-administered Subcutaneous Trastuzumab as Adjuvant Therapy in Patients with Operable HER2-positive Early Breast Cancer

• IRAS ID

  98125

• Contact name

  Mark Verrill

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2011-005328-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is looking for male and female patients with newly diagnosed, early breast cancer. To enter the study patients must have a breast cancer that has a protein called HER2 present on the surface of its cells. They must also be suitable for adjuvant (given after surgery) treatment with Herceptin© (trastuzumab). Normally, Herceptin is given as a drip in to a vein (iv infusion) in the arm over 30 to 90 minutes every 3 weeks (a treatment cycle). The study will assess safety and any side effects and how patients handle them when it is given by an injection under the skin on the thigh (subcutaneous) over 5 minutes every 3 weeks. The number and type of side effects experienced by patients on the study will be recorded, as well as how effective the treatment is. Patients will receive 18 cycles of treatment (1 year), which is the standard length of treatment for Herceptin in early breast cancer. Patients will either be given the subcutaneous injection of Herceptin using a standard hand-held syringe and needle or using a single use device, pre-loaded with Herceptin, which is placed on the thigh. If the patient is being given the treatment using the device, they will be shown how to give it themselves under the supervision of the nursing team for at least two doses. The study doctor will decide which way of giving the injection is more suitable for the patient. Patients who use the device will be asked about the experience in a questionnaire.Patients will have a follow-up visit 4 weeks after completing their study treatment. Additional follow-up visits will be made in line with their hospital??s normal practice for at least 2 years.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0139

• Date of REC Opinion

  29 Mar 2012

• REC opinion

  Favourable Opinion