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New drug takes on T-DXd in breast cancer showdown

NCT ID NCT07416253

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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