For the neoadjuvant (before surgery) treatment of HER2-positive breast cancer, a combination of Herceptin® (trastuzumab) and Tykerb® (lapatinib) may be more effective than either drug alone. These results were published in The Lancet.

Approximately 20-25% of breast cancers overexpress (make too much of) a protein known as HER2. Fortunately, the development of drugs that specifically target HER2-positive breast cancer has improved outcomes. These drugs include Herceptin, Tykerb, and the investigational drug pertuzumab.

Combinations of HER2-targeted therapies have shown a benefit in studies of women with metastatic breast cancer (cancer that has spread to other parts of the body), and researchers are also evaluating these combinations in women with earlier-stage breast cancer.

The NeoALTTO study is a Phase III clinical trial that enrolled 455 women with early, HER2-positive breast cancer. The study was restricted to women with operable breast cancer greater than 2 cm in size. Study participants were assigned to one of three neoadjuvant (before surgery) treatment groups:

1)    Tykerb plus chemotherapy

2)    Herceptin plus chemotherapy

3)    Herceptin plus Tykerb plus chemotherapy

The primary outcome of the study was the pathological complete response (pCR) rate. A pCR refers to the disappearance of detectable cancer at the time of surgery. After surgery, patients received additional chemotherapy and HER2-targeted therapy.

Response rates were highest among women treated with the combination of Herceptin and Tykerb: a pCR was achieved by 51.3% of women in the combined Herceptin/Tykerb group, 29.5% of women in the Herceptin group, and 24.7% of women in the Tykerb group.

These results suggest that a combination of Herceptin and Tykerb may be more effective than either drug alone. The difference between Herceptin alone and Tykerb alone was not statistically significant in this study (i.e. it could have been due to chance alone), but the results of another study—published in Lancet Oncology—suggest that if only one the drugs is used, Herceptin may be more effective.


Baselga J, Bradbury I, Eidtmann H et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomized, open-label, multicentre, phase 3 trial. Lancet. 2012;379:633-40.

Untch M, Loibl S, Bischoff J et al. Lapatinib versus trastuzumab in combination with neoadjuvant antrhacycline-taxane-based chemotherapy (GeparQuinto, GBG44): a randomized phase 3 trial. Lancet Oncology. 2012;13:135-144.

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