Recent research into modern breast cancer therapies have driven major breakthroughs in antibody-drug conjugates, or “smart drugs,” which work by targeting cancer cells while minimizing damage to healthy body tissue.
Kadcyla, also known ado-trastuzumab emtansine (T-DM1), is one of the latest “smart drugs” to be FDA-approved in the treatment of women diagnosed with metastatic HER2-positive breast cancer. Kadcyla may also have potential as therapy after surgery where intent is curative.
Breastlink participated in the EMILIA trial, a key clinical trial that helped lead to swift approval of Kadcyla for HER2-positive advanced breast cancer. We also are participating in other ongoing trials to investigate additional uses for Kadcyla in HER2 positive breast cancer treatments.
EMILIA Clinical Trial – HER2 Positive Breast Cancer Treatment
The EMILIA trial studied the efficacy and safety of Kadcyla in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and taxane-based chemotherapy. Nearly 1,000 total patients were split evenly into a group treated with lapatinib and capecitabine and a group treated with Kadcyla.
Kadcyla is the only available breast cancer treatment that delivers HER2-targeted treatment and chemotherapy at the same time.
- Trastuzumab, an antibody, prohibits the growth of tumor cells by binding to HER2 receptors while lethal doses of DM1, a chemotherapy agent, are delivered to the interior of cancer cells, which destroys the cell from the inside.
The Kadcyla group saw improved outcomes compared to the lapatinib-capecitabine group as measured by overall survival rates and progression-free survival rates. Estimated 1-year survival rates were 85.2 percent among the Kadcyla group compared to 78.4 percent among the lapatinib-capecitabine. Estimated 2-year survival rates were, respectively, 64.17 percent compared to 51.8 percent.
These results, as researchers note in a November 2013 article in New England Journal of Medicine, indicated Kadcyla offered a higher chance for “significantly improved progression-free survival” than other treatments available for women with previously treated HER2-positive advanced breast cancer.
New Kadcyla Clinical Trials, HER2 Positive Breast Cancer Treatment and Breastlink.
At this time, Kadcyla is only FDA-approved for patients with metastatic HER2-positive breast cancer after prior treatment with Herceptin and taxane-based chemotherapy. However, we believe there is potential for this targeted therapy to also help patients with earlier stage HER2 positive breast cancer treatment.
New studies are moving from metastatic cancer populations to exploring the efficacy and safety of antibody-drug conjugates in the adjuvant setting (treatment that is given in addition to curative surgery).
We are excited to share that Breastlink was the first study location in California to recruit patients for the KAITLIN (NCT01966471) study.
What is the KAITLIN Clinical Trial?
“A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer.”
The purpose of this significant phase III clinical trial is to assess the use of Kadcyla for adjuvant use in patients with operable HER2-positive breast cancer. More specifically, the study will evaluate the efficacy and safety of Kadcyla in combination with Perjeta (pertuzumab) versus Herceptin in combination with Perjeta and a taxane-based chemotherapy as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. This study is expected to last for one year.
One of the principal goals of the study is to find out which is better to prevent or delay recurrence of HER2-positive breast cancer. As such, the study is focused on women with a high risk of recurrence.
At Breastlink, we are committed to the medical community’s efforts to improve breast cancer therapies and are excited participate in such exciting research. Based on the results of past research projects, like the EMILIA trial, we believe Kadcyla is showcasing the power and potential of targeted therapies. We are honored by the invitation to continue playing a role in ongoing research and, through these collaborative efforts, hope to help develop breast cancer treatments that save lives.
It is important to note that the KAITLIN study is not appropriate for all breast cancer patients. If you are interested in more information about this HER2 positive breast cancer treatment study, please:
- Visit the U.S. National Institutes of Health website.
- Contact our research office at (562) 981-6101.