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
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The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.