Clinical trials study how well a new treatment or procedure works in people. The studies are done under careful supervision and help doctors identify the best treatments with the fewest side effects. Clinical trials help improve the standard of care for cancer and other diseases.
Breastcancer.org is featuring the clinical trials below to help raise awareness of new breast cancer treatments being studied, especially for metastatic disease. The content on this page is made possible by the support of our partners.
The safety and scientific validity of these studies are the responsibility of the studies’ sponsors and investigators. Listing a study here does not mean it has been evaluated by Breastcancer.org. The content on this page is made possible by the support of our partners.
Before you think about being part of a clinical trial, talk to your doctor and make sure you know the benefits and risks of participating in a trial. For more information on clinical trials, including how to find clinical trials, visit the Breastcancer.org Clinical Trials pages.
- HER2CLIMB-02 Trial for advanced or metastatic HER2-positive breast cancer
- IPATunity130 Trial for advanced or metastatic triple-negative breast cancer
- DESTINY-Breast05 Trial for HER2-positive breast cancer without a pathologic complete response from treatment before surgery (neoadjuvant treatment)
- DESTINY-Breast06 Trial for metastatic hormone-receptor-positive breast cancer with low HER2 levels that has been previously treated with at least two hormonal therapies
The HER2CLIMB-02 trial is a phase III trial for people diagnosed with metastatic HER2-positive breast cancer or locally advanced HER2-positive disease that can’t be completely removed with surgery.
The trial is looking to see if Tukysa (chemical name: tucatinib) given in combination with Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine) will offer more benefits than Kadcyla alone.
The IPATunity130 trial is a phase III trial currently enrolling people with locally advanced or metastatic triple-negative breast cancer with a PIK3CA, AKT1, or PTEN genetic mutation. Triple-negative breast cancer is cancer that is estrogen-receptor-negative, progesterone-receptor-negative, and HER2-negative.
The trial is looking to see if adding the experimental medicine ipatasertib to Taxol (chemical name: paclitaxel), a taxane chemotherapy medicine, will offer more benefits than Taxol alone. Ipatasertib is an AKT inhibitor. The PI3K/AKT pathway helps all cells — both healthy and cancer cells — get the energy they need. When this pathway is mutated or overactivated, which can happen if the cancer has a PIK3CA, AKT1, or PTEN mutation, it can allow cancer cells to survive and grow. AKT inhibitors block a protein called AKT in this pathway with the goal of killing cancer cells.
Note: The IPATunity130 trial also has an arm that includes people diagnosed with hormone-receptor-positive breast cancer, but that arm is no longer enrolling participants.
The DESTINY-Breast05 trial is a phase III trial for people diagnosed with HER2-positive breast cancer that did not have a pathological complete response from treatment given before surgery. One way doctors judge the effectiveness of treatments given before surgery is to look at the tissue removed during surgery to see if any actively growing cancer cells are present. If no active cancer cells are present, doctors call it a “pathologic complete response” or pCR.
The trial is looking to see if the medicine fam-trastuzumab-deruxtecan-nxki (brand name: Enhertu) offers more benefits compared with Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine) when given after surgery to destroy any remaining active cancer cells.
The DESTINY-Breast06 trial is a phase III trial for people diagnosed with metastatic hormone-receptor-positive breast cancer with low levels of HER2. The cancer has to have been previously treated with at least two hormonal therapy medicines.
In this study, HER2-low breast cancer means the cancer has a score of 1+ or 2+ on an immunohistochemistry (IHC) HER test and/or a negative result on a in situ hybridization (ISH) HER2 test. Breast cancer with these IHC or ISH scores would usually be considered HER2-negative breast cancer. Still, earlier studies have shown that the medicine being studied may help treat breast cancers with very low HER2 levels, which is why this larger study is being done.
The trial is looking to see if the medicine fam-trastuzumab-deruxtecan-nxki offers more benefits than your doctor’s choice of chemotherapy.
To inquire about listing a clinical trial, please contact firstname.lastname@example.org.
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