Sponsored Clinical Trials
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.
IPATunity130 Trial
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.
ELAINE Trial
The ELAINE (Evaluating Lasofoxifene in ESR1 Mutations) trial is a phase II trial for postmenopausal women diagnosed with locally advanced or metastatic estrogen-receptor-positive, HER2-negative breast cancer with an ESR1 mutation who have had the cancer grow while being treated with an aromatase inhibitor in combination with a CDK4/6 inhibitor.
The aromatase inhibitors used to treat breast cancer are:
- Arimidex (chemical name: anastrozole)
- Aromasin (chemical name: exemestane)
- Femara (chemical name: letrozole)
The CDK4/6 inhibitors used to treat breast cancer are:
- Ibrance (chemical name: palbociclib)
- Kisqali (chemical name: ribociclib)
- Verzenio (chemical name: abemaciclib)
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. Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver.
The trial is looking to see if the medicine lasofoxifene, which is taken as a pill, will offer more benefits than Faslodex (chemical name: fulvestrant), which is given as two injections into a muscle once a month.
Lasofoxifene is selective estrogen receptor modulator (SERM). Tamoxifen, Evista (chemical name: raloxifene), and Fareston (chemical name: toremifene) are other SERMs. The ESR1 gene is an estrogen receptor gene. When this gene mutates, it can make breast cancer resistant to hormonal therapies, including aromatase inhibitors. Earlier studies on animals have shown that lasofoxifene may be able to help treat metastatic breast cancers with ESR1 mutations. Research suggests that about 30% of metastatic breast cancers may have an ESR1 mutation.
To inquire about listing a clinical trial, please contact partnerships@breastcancer.org.
