MetaPHer
Research type
Research Study
Full title
A multicentre, open-label, single-arm safety study of Herceptin® SC in combination with Perjeta® and Docetaxel in treatment of patients with HER2-positive advanced breast cancer (metastatic or locally recurrent)
IRAS ID
169540
Contact name
Andrew Wardley
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2014-001458-40
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
The purpose of this study is to evaluate the safety and patient’s tolerability to a new way to administer Herceptin (into the fatty layer under the skin: subcutaneous) when used in combination with Perjeta plus docetaxel in advanced breast cancer. The combination of the three drugs in advanced breast cancer is becoming the standard of care in more and more countries; however, Herceptin is usually given as a drip into a vein (intravenous infusion) when used in combination with Perjeta as an intravenous infusion and docetaxel as an intravenous infusion.
Herceptin and Perjeta are antibodies, similar to a class of proteins existing in the body, and have been developed to specifically fight cancer cells that are “HER2 positive.” Docetaxel, the third drug used in the study, is a type of cytotoxic chemotherapy (toxic drug/agent that kills cancer cells).
Previous research results have shown that Herceptin can be safely injected into the fatty layer under the skin (subcutaneously) with the same efficacy as Herceptin given as a drip into a vein (intravenously). This new way of administration, approved in many countries, may allow for a faster and more convenient application than the intravenous way.
Perjeta intravenous infusion treatment is approved to be given in combination with Herceptin intravenous infusion and docetaxel intravenous infusion for treatment of early breast cancer before surgery and for breast cancer that has spread to other parts of the body (metastatic cancer).
Patients who benefit from this type of therapy must have a certain type of breast cancer which is called “HER2 positive.” HER2 is a protein that is overproduced by some cancer cells and makes the tumour more aggressive. If the HER2-positive status of the patients’ primary tumour (and/or metastasis) has been confirmed, they are allowed to enter this study. Herceptin and Perjeta act by inhibiting this HER2 receptor, which makes the cancer cell die. It is thought that the patient may respond to treatments with antibodies such as Herceptin and Perjeta. In addition, safety data from previous studies suggest that this combination is well tolerated.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0152
Date of REC Opinion
20 May 2015
REC opinion
Further Information Favourable Opinion