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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.

DESTINY-Breast02 Trial

The DESTINY-Breast02 trial is a phase III trial for people diagnosed with metastatic HER2-positive breast cancer or other stages of HER2-positive disease that can’t be removed with surgery and have been previously treated with Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine).

The trial is looking to see if the medicine fam-trastuzumab-deruxtecan-nxki offers more benefits than either Herceptin (chemical name: trastuzumab) and Xeloda (chemical name: capecitabine) or Tykerb (chemical name: lapatinib) and Xeloda.

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DESTINY-Breast04 Trial

The DESTINY-Breast04 trial is a phase III trial for people diagnosed with metastatic breast cancer with low HER2 levels or other stages of breast cancer with low HER2 levels that can’t be removed with surgery. For the purposes of this study, breast cancer with low HER2 levels means the cancer has a score of 2+ or 1+ on an immunohistochemistry (IHC) HER2 test or a negative fluorescence in situ hybridization (FISH) HER2 test. Breast cancer with these IHC or FISH 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 extremely low HER2 levels, which is why this larger study is being done.

The cancer also must have been previously treated with one or two chemotherapy regimens for people to be eligible for this study.

The trial is looking to see if the medicine fam-trastuzumab-deruxtecan-nxki offers more benefits than your doctor’s choice of four chemotherapy medicines:

  • Xeloda (capecitabine)
  • Halaven (chemical name: eribulin)
  • Gemzar (chemical name: gemcitabine)
  • Taxol (chemical name: paclitaxel)
  • Abraxane (chemical name: albumin-bound or nab-paclitaxel)

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HER2CLIMB-02 Trial

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.

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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.

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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 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.

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To inquire about listing a clinical trial, please contact partnerships@breastcancer.org.

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Last modified on August 26, 2020 at 9:26 AM

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