What is Herceptin?
Herceptin is a powder to make a solution for infusion (drip into a vein). Herceptin contains the active substance trastuzumab.
What is Herceptin used for?
Herceptin is indicated for the treatment of breast cancer. It can only be used when the tumor has been shown to "express" large amounts of HER2, that is, in the types of cancer that produce large amounts of a specific protein, HER2, on the surface of cancer cells.
Herceptin is used in metastatic breast cancer (when the cancer has spread to other parts of the body). Herceptin is also indicated for early-stage breast cancer (spread to the breast or glands under the arm, but not to other parts of the body).
In case of cancer the Herceptin metastatic breast can be used as follows:
- alone in patients who have previously been subjected to at least two therapies without a positive result,
- in combination with paclitaxel or docetaxel (other anticancer medicines),
- in combination with an aromatase inhibitor (another type of anticancer medicine) in post-menopausal women whose tumor has also expressed on the surface hormone receptors such as estrogen and progesterone.
For the treatment of breast cancer at an early stage, Herceptin is indicated after surgery and chemotherapy (and possibly radiotherapy).
The medicine can only be obtained with a prescription.
How is Herceptin used?
Treatment with Herceptin should only be started by a doctor experienced in administering anticancer medicines. The infusion may be associated with allergic reactions, so the patient must be monitored during administration. In the treatment of metastatic cancer Herceptin is administered weekly or every three weeks and the therapy is continued until it ceases to be effective. In the treatment of the tumor in the initial phase the administration takes place every 3 weeks for a year, or until it ceases to be effective. Herceptin can also be given weekly in combination with other anticancer medicines. For complete instructions on the dosage, see the summary of product characteristics (also included with the EPAR).
How does Herceptin work?
The active substance in Herceptin, trastuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific substance (the antigen) present on certain cells in the body. Trastuzumab was created to bind to HER2, a receptor for epidermal growth factor, which is found on the surface of some cancer cells. By binding to the receptor, trastuzumab activates certain cells of the immune system (the body's natural defense system) that destroy cancer cells. It also prevents the HER2 receptor from dividing, thus preventing the signal to grow from being sent to the tumor. About a quarter of breast cancers produce large amounts of HER2.
What studies have been carried out on Herceptin?
All studies of Herceptin have been conducted in patients with cancer that produce HER2.
In weekly metastatic breast cancer Herceptin was the subject of four major studies. A study of 222 patients examined the use of Herceptin alone in patients who had not previously responded to other types of chemotherapy and two were studying the use of Herceptin in combination with two other anticancer agents (paclitaxel in 469 patients and docetaxel, on 188 patients). These studies measured how many patients responded to treatment. The fourth study compared the combination of Herceptin and anastrozole (an aromatase inhibitor) with anastrazole alone in 208 patients. The main measure of effectiveness was "median progression-free survival" (time elapsed until 50% of patients show a worsening of the disease or die). Four additional studies looked at the response to Herceptin given once every three weeks, either alone (two studies with 177 patients), or in combination with paclitaxel (out of 32 patients) or in combination with docetaxel, with or without capecitabine (another antitumor drug) on 225 patients.
Herceptin in early breast cancer Herceptin has been studied over 1-2 years in a main study involving over 3, 000 previously treated patients with surgery, chemotherapy or radiotherapy. One half of the patients received Herceptin, the other half did not. The study measured the time interval before the tumor reappeared anywhere in the body.
What benefit has Herceptin shown during the studies?
Regarding metastatic breast cancer, in the first study 15% of patients who had not responded to other types of chemotherapy responded to Herceptin therapy. When Herceptin was used in combination with paclitaxel, the response rate was 48% compared with 17% with paclitaxel alone. With docetaxel, 61% of patients responded to therapy, compared with 34% for docetaxel alone. When Herceptin was used in combination with anastrozole, the median progression-free survival was 4.8 months versus 2.4 months in patients taking anstrozole alone. Additional studies showed that the effectiveness of Herceptin administered once every three weeks was similar to that observed in the once-weekly medicinal product studies.
In the early stage breast cancer study the risk of recurrence of the tumor (relapse) within the first year was reduced by half: 8% of the patients treated with Herceptin had relapses (127 of 1, 693) compared to 13% of the patients who had not received the medicine (219 out of 1693).
What are the risks associated with Herceptin?
Herceptin can cause cardiotoxicity (heart damage), including heart failure. Care must be taken if the medicine is given to cardiac patients; during treatment the heart of all patients must be monitored. The most common side effects with Herceptin (seen in more than 1 patient in 10) are abdominal pain, asthenia (weakness), chest pain, fever, headache, pain, diarrhea, nausea, vomiting, arthralgia (joint pain), myalgia ( muscle pain) and rashes. For the full list of all side effects reported with Herceptin, see the Package Leaflet.
Herceptin should not be used in patients who are hypersensitive (allergic) to trastuzumab or to any of the excipients and in patients who have severe breathing problems when they are at rest due to the tumor or to patients who need oxygen therapy.
Why has Herceptin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Herceptin outweigh the risks in the treatment of patients with metastatic breast cancer that produces HER2 in greater than normal amounts and in patients with breast cancer undergoing initial HER2-positive. The Committee recommended that Herceptin be given marketing authorization.
What measures are being taken to ensure the safe use of Herceptin?
The manufacturer of Herceptin will conduct further studies on cardiotoxicity, also with reference to the guidance given to physicians and the methodologies to identify patients at risk of heart problems in order to ensure that they are carefully monitored.
More information on Herceptin:
On 28 August 2000, the European Commission granted a marketing authorization for Herceptin, valid throughout the European Union, to Roche Registration Limited. The marketing authorization was renewed on 28 August 2005.
The full EPAR for Herceptin can be found here.
Last update of this summary: 09-2008.
