7 Breast Cancer Clinical Trials Currently Enrolling in the US

For people newly diagnosed with breast cancer or living with disease that has progressed, a clinical trial can open the door to treatments not yet available anywhere else. Below are seven trials actively recruiting participants across the country right now, covering early-stage disease through heavily pretreated metastatic cancer. Eligibility criteria are complex and vary by site, so anyone interested should talk with their care team about whether one of these studies might be a fit.

1. TROPION-Breast04: Datroway Plus Imfinzi Before Surgery for Early-Stage Triple-Negative or HR-Low Breast Cancer

This phase 3 trial (NCT06112379) is testing Datroway (datopotamab deruxtecan) combined with Imfinzi (durvalumab) as a pre-surgery, or neoadjuvant, treatment for people with previously untreated stage ii-iii triple-negative or HR-low, HER2-negative breast cancer. After surgery, participants continue on adjuvant Imfinzi. The study is comparing this combination against the current standard of care, chemotherapy plus Keytruda (pembrolizumab). Enrollment is open to adults 18 and older with an ECOG performance status of 0 or 1 and no prior treatment with a PD-1, PD-L1 or PD-L2 inhibitor.

2. ReDiscover-2: Zovegalisib or Truqap for HR-Positive, PIK3CA-Mutant Breast Cancer After a CDK4/6 Inhibitor

People with hormone receptor-positive, HER2-negative advanced breast cancer whose disease has progressed on a CDK4/6 inhibitor and who carry a PIK3CA mutation may qualify for this phase 3 trial (NCT06982521). It compares the investigational drug zovegalisib (RLY-2608) plus Faslodex (fulvestrant) against Truqap (capivasertib) plus Faslodex. Eligible participants must not have received a prior PI3K, AKT or mTOR pathway inhibitor and cannot have uncontrolled diabetes or active brain metastases requiring steroids.

3. EmpowHER-303: Ziihera Versus Herceptin for HER2-Positive Breast Cancer After Enhertu

For people with metastatic HER2-positive breast cancer whose disease progressed on, or who could not tolerate, Enhertu (trastuzumab deruxtecan), this phase 3 trial (NCT06435429) offers a next option. It compares the newer antibody Ziihera (zanidatamab) with standard Herceptin (trastuzumab), each paired with a chemotherapy chosen by the treating physician. Participants must have received two to four prior lines of HER2-directed therapy and have a left ventricular ejection fraction of 50% or higher.

4. TROPION-Breast05: Datroway With or Without Imfinzi for PD-L1-Positive Metastatic Triple-Negative Breast Cancer

This phase 3 study (NCT06103864) is recruiting people with locally recurrent, inoperable or metastatic triple-negative breast cancer whose tumors test PD-L1-positive. It compares Datroway alone or with Imfinzi against chemotherapy plus Keytruda, the current standard first-line approach for this population. The trial is open to adults 18 and older who have not yet received systemic treatment for advanced disease. (Datroway already holds full FDA approval as a first-line option for metastatic triple-negative breast cancer in people who aren't candidates for a PD-1/PD-L1 inhibitor, so this trial is filling in the picture for those who are.)

5. TroFuse-011: Sacituzumab Tirumotecan With or Without Keytruda for Metastatic Triple-Negative Breast Cancer

This phase 3 trial (NCT06841354) is evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT), alone or combined with Keytruda, against standard chemotherapy in people with previously untreated, locally recurrent or metastatic triple-negative breast cancer whose PD-L1 combined positive score is below 10. Participants must be candidates for both Keytruda and standard chemotherapy options such as paclitaxel or gemcitabine plus carboplatin, and cannot have grade 2 or higher peripheral neuropathy or active hepatitis B or C.

6. DATO-BASE: Datroway for Breast Cancer That Has Spread to the Brain

Brain metastases often exclude people from clinical trials, which is what makes this phase 2 study (NCT06176261) notable. It's testing Datroway specifically in people with HER2-negative metastatic breast cancer that has spread to the brain, including tumors that are unirradiated or have progressed after prior treatment. Eligible participants need at least one measurable brain lesion of 1 centimeter or larger, an ECOG performance status of 0 to 2 and adequate organ function; those with a recent seizure history or symptomatic bleeding in the brain are excluded.

7. Bria-ABC: An Off-the-Shelf Immunotherapy for Metastatic Breast Cancer With No Approved Options Left

For people with advanced or metastatic breast cancer who have exhausted approved therapies, this phase 3 trial (NCT06072612) is testing Bria-IMT, an off-the-shelf cellular immunotherapy designed to activate the immune system against cancer cells, administered alongside interferon and, in some cases, a checkpoint inhibitor. The study has been expanding its site network this year, including to Memorial Sloan Kettering Cancer Center. It's open to adults 18 and older with advanced or metastatic breast cancer who have no other approved treatment available to them.

This list isn't exhaustive, and eligibility for any trial depends on factors like biomarker status, prior treatment history and overall health. People interested in participating should ask their oncologist about trial matching or search ClinicalTrials.gov directly using the NCT numbers above.

References

1. "A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer," ClinicalTrials.gov; https://clinicaltrials.gov/study/NCT06112379
2. "Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer," ClinicalTrials.gov; https://clinicaltrials.gov/study/NCT06982521
3. "A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer," ClinicalTrials.gov; https://clinicaltrials.gov/study/NCT06435429
4. "A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)," AstraZeneca Clinical Trials; https://www.astrazenecaclinicaltrials.com/study/D7630C00001/
5. "A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)," UCSF Clinical Trials; https://clinicaltrials.ucsf.edu/trial/NCT06841354
6. "DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs," Dana-Farber Cancer Institute; https://www.dana-farber.org/clinical-trials/23-533
7. "BriaCell's Bria-IMT™ Clinical Trial: A Patient's Guide," BriaCell Therapeutics; https://briacell.com/a-patients-guide-to-briacell-bria-imt-clinical-trial/
8. "FDA Approves Datopotamab Deruxtecan-dlnk for Unresectable or Metastatic Triple-Negative Breast Cancer," U.S. Food and Drug Administration; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
9. "Ziihera (zanidatamab-hrii) FDA Approval History," Drugs.com; https://www.drugs.com/history/ziihera.html