Herceptin Plus Chemo Before Surgery Better Than Chemo Alone for HER2-Positive Locally Advanced Disease

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Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from the breast, such as the bones or brain.

Inflammatory breast cancer is an uncommon but aggressive form of breast cancer with symptoms that include swelling, redness, and tenderness of the breast.

A study suggests that giving Herceptin (chemical name: trastuzumab) at the same time as chemotherapy BEFORE surgery for HER2-positive locally advanced or inflammatory breast cancer can lengthen the time before the cancer comes back (recurrence) or grows (called event-free survival) compared to chemotherapy alone. Treatments given before surgery are called neoadjuvant therapies. Treatments given after surgery are called adjuvant therapies. Neoadjuvant and adjuvant therapies are used to reduce the risk of the cancer coming back or growing.

Herceptin is a targeted therapy medicine commonly used to treat HER2-positive breast cancers AFTER surgery. HER2-positive cancers have too many copies of the HER2/neu gene, which make too much of the HER2 protein. About 35% of locally advanced and 40% of inflammatory breast cancers are HER2-positive. HER2-positive breast cancers tend to be more aggressive than HER2-negative breast cancers.

In this study, called the NOAH trial, half of 235 women diagnosed with HER2-positive locally advanced or inflammatory breast cancer got standard chemotherapy before surgery. The other women got standard chemotherapy AND Herceptin before surgery. Because all the breast cancers were HER2-positive, all the women were treated with Herceptin after surgery. The women were followed for 3 or more years.

Women who got chemotherapy and Herceptin before surgery were 41% more likely to be alive without the cancer coming back or growing 3 years after surgery compared to women who got only chemotherapy before surgery.

  • Three years after surgery, 71% of the women who got chemotherapy and Herceptin before surgery were alive with no recurrence or cancer growth compared to 59% of the women who got only chemotherapy before surgery.

Women who got chemotherapy and Herceptin before surgery had better overall survival compared to women who got only chemotherapy before surgery.

  • Three years after surgery, 87% of the women who got chemotherapy and Herceptin before surgery were alive, compared to 79% of the women who got only chemotherapy.

Still, the overall survival difference wasn't statistically significant, which means it could have been due to chance and not because of the different treatment plans.

The researchers also followed a different group of 99 women who were diagnosed with HER2-negative locally advanced or inflammatory breast cancer for 3 years. The women got chemotherapy before and after surgery, but no Herceptin because the cancer was HER2-negative. HER2-positive breast cancers are usually more aggressive than HER2-negative cancers. Still, after 3 years, the women in the study diagnosed with HER2-positive breast cancer who got Herceptin and chemotherapy before surgery had outcomes that were similar to the women diagnosed with HER2-negative breast cancer.

Most of the women who got Herceptin before surgery didn't have any serious side effects. Herceptin is given intravenously and can cause flu-like symptoms in about 40% of the people who receive it. Any side effects are usually less severe after the first treatment. Herceptin also has a 5% to 30% risk of damaging the heart's ability to pump blood. The risk of serious heart damage goes up when Herceptin is given with chemotherapy medicines known to cause heart damage, such as Adriamycin (chemical name: doxorubicin). In this study, four of the women who got Herceptin with chemotherapy before surgery had decreased heart function -- two of the women had no symptoms; the other two women got better after Herceptin treatment was done.

Herceptin is approved by the U.S. Food and Drug Administration (FDA) to treat metastatic, HER2-positive breast cancers and to lower the risk of recurrence of early-stage, HER2-positive breast cancer with a high risk of recurrence. Herceptin has not been approved by the FDA to treat locally advanced or inflammatory breast cancer before surgery. Still, based on the results of this study, using Herceptin to treat HER2-positive locally advanced or inflammatory breast cancer before surgery may make sense for many women.

If you've been diagnosed with HER2-positive locally advanced or inflammatory breast cancer, Herceptin will likely be a part of your treatment plan after surgery. You may want to talk to your doctor about this study and ask if Herceptin and chemotherapy BEFORE surgery is a good choice for you. Together, you and your doctor can decide on the best treatment plan for your unique situation.

Visit the Breastcancer.org Targeted Therapies section to learn more about Herceptin and other targeted therapies used to treat breast cancer.

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