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Shining a Spotlight on Promising Clinical Trials in 2025 

The beginning of a new year brings hope for clinical trials, because it often means the start of new research, new discoveries and new advancements that may help to improve the lives of patients. Clinical trials are the vital connection between laboratory findings and patients in the clinic. Below, we’re shining a spotlight on some promising clinical trials in 2025. These studies are made possible through the hard work of a collaborative team that includes brilliant researchers, as well as doctors who help design the trials, and most important, the patients who volunteer their time and energy.  

COMET (Active, not recruiting) 

This phase 3 study is testing the effectiveness of active monitoring vs. surgery in treating low risk ductal carcinoma in situ (DCIS), a type of non-invasive breast cancer. The main objective of this study is to see if just watching and monitoring DCIS (instead of performing surgery) will lead to similar outcomes and quality of life for participants.  

What it Means for Patients: 

Some people may be over diagnosed and treated for cancers that would never have caused harm, leading to unnecessary treatments and costs. Surgery for DCIS may cause long-term pain, which is a major problem for many patients, especially after lumpectomy or mastectomy. With the alternative of active monitoring, the hope is that patients can avoid these issues while experiencing the same outcomes and quality of life. 

EMBER-4 (Active, recruiting) 

Following the recent results of EMBER-3, this phase 3 study is testing how well the oral selective estrogen receptor degrader (SERD), imlunestrant, works in comparison to standard hormone therapy in patients with early stage, high-risk estrogen receptor-positive (ER+) HER2-negative (HER2-) breast cancer. Results of the EMBER-3 trial presented at SABCS have shown that imlunestrant alone reduced cancer progression by 38% in participants with metastatic ER+ HER2- breast cancer, and reduced progression by 43% when paired with the CDK4/6 inhibitor abemaciclib. 

What it Means for Patients: 

With such promising study results from EMBER-3, imlunestrant is likely to be approved by the FDA in the coming year. Aside from its promising anti-tumor activity, imlunestrant could also help patients with early-stage disease who have a high risk of recurrence. 

OlympiA (Active, not recruiting) 

This phase 3 study is testing if olaparib (Lynparza), a PARP inhibitor, helps people with high-risk, HER2-negative breast cancer who have BRCA1/2 gene mutations and had already completed surgery and chemotherapy. Results shared at SABCS showed olaparib significantly improved overall survival for these patients, including a 28% reduction in risk of death.  

What it Means for Patients: 

These study findings suggest that olaparib could be a great treatment option for early-stage breast cancer patients with BRCA gene mutations, potentially improving their long-term survival. 

TNBC Vaccine Study (Active, recruiting) 

This phase 1 study is testing a new breast cancer vaccine that may stimulate the body’s immune system to attack tumor cells. The new αlpha-lactalbumin vaccine is being studied for treatment of triple negative breast cancer (TNBC) and has already shown positive results. Over 70% of participants had immune responses as expected from the treatment, according to the study results presented in Nov. 2024 at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. 

“Research cures cancer, but only if the research gets from the laboratory to the clinic. The only way this happens is through clinical trials.” – George Sledge, M.D., Former Komen Chief Scientific Advisor

What it Means for Patients: 

The alpha-lactalbumin vaccine was safe and well-tolerated in all three patient groups, with mild irritation at the injection site as the main side effect. No serious side effects were found, even when the vaccine was used along with pembrolizumab (Keytruda). A phase 2 trial in the neoadjuvant setting (given before surgery) is planned in patients with newly diagnosed breast cancer and scheduled to begin in 2025. 

INAVO120 (Active, not recruiting) 

This phase 3 trial is exploring the potential of oral inhibitor inavolisib combined with targeted therapy palbociclib and hormone therapy fulvestrant for people with hormone receptor-positive (HR+), HER2-, locally advanced or metastatic breast cancer (MBC), particularly those with PIK3CA gene mutations. Recent results show that participants who took inavolisib + palbociclib + fulvestrant reported 15 months without their cancer growing or spreading compared to those who took placebo + palbociclib + fulvestrant, who reported seven months before the cancer worsened. 

What it Means for Patients: 

Study participants who took inavolisib reported more than twice the amount of time without their cancer growing or spreading compared to those who didn’t take it. Inavolisib was approved by the FDA in Oct. 2024, marking a major step forward in precision medicine for patients. 

DESTINY-Breast06 (Active, not recruiting) 

This phase 3 study is investigating how well trastuzumab deruxtecan (T-DXd) works, how safe it is and how well patients can tolerate it, compared to chemotherapy chosen by their doctor. This study is for patients with HER2-low, hormone receptor-positive (HR+) breast cancer whose cancer has gotten worse after using hormone therapy. So far, study results show T-DXd significantly improves progression-free survival in patients with HR+ metastatic breast cancer (MBC), as well as overall survival. 

What it Means for Patients: 

As of January 2025, the FDA has approved T-DXd for treatment of HER2-Low/Ultralow breast cancer who have previously been treated with at least one type of hormone therapy in the metastatic setting, based on the results of DESTINY-Breast06. This study marks significant progress in expanding treatment options for people living with MBC.  

To learn more about clinical trials or to read about more breast cancer trials featured on Komen.org, visit our Breast Cancer Clinical Trials page. 

If you’d like more information about choosing a clinical trial, BreastCancerTrials.org in collaboration with Susan G. Komen®, offers a custom matching service to help find clinical trials that fit your needs.    

For questions or additional information about clinical trials, contact Komen’s Patient Care Center at: https://komen.org/patientcarecenter. To get help, call (877) 465-6636 or email helpline@komen.org.