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Breast CancerJuly 2022Summary reviewed May 2026

What the DESTINY-Breast04 Trial Found — Trastuzumab Deruxtecan for HER2-Low Breast Cancer

DESTINY-Breast04 tested trastuzumab deruxtecan in a population doctors used to consider untreatable with HER2-targeted therapy: women whose tumors had only low levels of HER2. Across 557 women, the drug roughly doubled the time before cancer progressed and improved overall survival.

What the trial was testing

The DESTINY-Breast04 enrolled 557 patients with breast cancer. The study was sponsored by Daiichi Sankyo and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

Roughly doubled the time before cancer progression in HER2-low breast cancer.

New England Journal of Medicine · 2022 · NCT03734029

These findings — that median time before cancer progression on trastuzumab deruxtecan vs. chemotherapy in HER2-low metastatic breast cancer — were published in the New England Journal of Medicine and represent the headline result of the study.

Researchers tracked outcomes across 557 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with breast cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Trastuzumab deruxtecan (Enhertu) is FDA-approved for HER2-low metastatic breast cancer that has been previously treated with chemotherapy and available now. It is given as an IV infusion every three weeks. A serious lung side effect is a known risk and requires careful monitoring. Ask your oncologist about HER2-low testing and eligibility.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.

Open breast cancer trials

RecruitingSafety & dosing

Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.

Shanghai, Shanghai Municipality, China
RecruitingInterventional study

Effect of Mandala Coloring on Anxiety, Distress, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy

Breast cancer patients receiving chemotherapy often experience psychological distress, anxiety, and discomfort during treatment. Non-drug supportive methods may help improve patients' well-being during chemotherapy. This study aims to evaluate whether mandala coloring during outpatient chemotherapy can reduce psychological distress and anxiety and improve comfort in breast cancer patients. Participants will be randomly assigned to either a mandala coloring group or a routine care group. Patients in the intervention group will color mandala patterns for 30 minutes during their chemotherapy session, while the control group will receive routine care only. Psychological distress, anxiety, and comfort levels will be measured before and after the chemotherapy session in both groups. The results of this study may provide evidence for a simple and low-cost supportive intervention to improve the psychological well-being of breast cancer patients during chemotherapy.

Artvin, Turkey (Türkiye)