New drug takes on T-DXd in breast cancer showdown
NCT ID NCT07416253
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a new drug, trastuzumab-rezetecan, works as well as the established drug T-DXd in shrinking HER2-positive breast tumors before surgery. About 68 women with early or locally advanced breast cancer will receive one of the two drugs for 8 cycles, then have surgery to see if the cancer has completely disappeared. The study aims to find a potential new treatment option for this type of breast cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trastuzumab-rezetecan (a targeted antibody-drug conjugate) compared to trastuzumab deruxtecan (T-DXd)
- What this could lead to
- If successful, this could show that trastuzumab-rezetecan is as good as or better than T-DXd at shrinking HER2+ breast tumors before surgery, potentially offering a new treatment option.
- What could go wrong
- This is a small, early-phase study (68 patients) comparing two similar drugs. It may not show a meaningful difference, and results may not apply to all patients. Side effects from antibody-drug conjugates can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Mar 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2030
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female, 18-75 years old, treatment-naive 2. ECOG PS 0-1 3. Histologically confirmed HER2+ (IHC 3+ or IHC 2+/ISH+) early/locally advanced breast cancer (AJCC 8th: cT2-cT4 any N cM0) or cT1c N+ cM0; known ER/PR status 4. Adequate organ function (hematology/biochemistry/coagulation/urine/cardiac) 5. Negative pregnancy test (childbearing women); agree to effective contraception 6. Sign an informed consent form. Exclusion Criteria: 1. Bbilateral/inflammatory/occult breast cancer. 2. Prior anti-tumor therapy (chemotherapy/radiotherapy/targeted therapy, etc.); radical radiotherapy (4 weeks prior) or palliative radiotherapy (2 weeks prior) to first dose. 3. Concurrent anti-tumor therapy; other malignancies (within past 5 years, except cured basal cell carcinoma/cervical CIS). 4. Prior trial participation (past 4 weeks); systemic immunosuppressants/hormones (\>10 mg/day prednisone equivalent, 2 weeks prior; nasal/inhaled steroids excluded). 5. Live/attenuated vaccine (past 4 weeks); major non-breast surgery (4 weeks prior, incomplete recovery). 6. Active/relapsing autoimmune disease (except controlled hypothyroidism/well-managed skin diseases/type 1 diabetes); immunodeficiency (HIV+/organ transplant). 7. Uncontrolled cardiovascular/cerebrovascular disease (e.g., MI/stroke in 6 months, NYHA III-IV heart failure, QTcF \>470 msec \[female\]). 8. Active ILD/severe lung disease; active hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL)/hepatitis C (HCV RNA+); severe infection requiring anti-infective therapy. 9. Bleeding/thrombotic tendency; hypersensitivity to study drugs/excipients. 10. Pregnant/lactating women; women of childbearing potential with positive pregnancy test or refusing contraception. 11. Other conditions (e.g., uncontrolled hypertension/diabetes, neuropsychiatric disorders) deemed unsuitable by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?