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Timing is everything: new trial seeks best sequence of targeted therapy for breast cancer

NCT ID NCT07657130

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial is recruiting 120 women with advanced HER2-negative breast cancer to find out whether it is better to receive antibody drug conjugates (ADCs) before chemotherapy or after. Participants will be randomly assigned to one of two sequences, and researchers will compare how long the cancer is controlled, overall survival, side effects, and quality of life. The goal is to optimize treatment timing for better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antibody drug conjugates (ADCs) such as trastuzumab deruxtecan or sacituzumab govitecan
What this could lead to
If successful, this trial could help doctors decide the best order to give ADC therapy and chemotherapy, potentially improving how long patients live without their cancer getting worse.
What could go wrong
This is a phase II trial with only 120 participants, so results are preliminary. The best timing may not clearly improve outcomes, and ADCs can cause side effects like nausea or low blood counts.

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 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 patients aged 18-75 years; 2. Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+/ISH-, IHC 1+/ISH-, and IHC 0/ISH- subtypes; 3. Completed first-line combination chemotherapy for advanced/metastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy); 4. Electrocorticography (ECOG) performance status \< 2; 5. Estimated life expectancy ≥ 12 weeks; 6. Adequate bone marrow function, defined as: * ANC ≥ 1.5 × 10⁹/L * Platelets ≥ 90 × 10⁹/L * Hemoglobin ≥ 90 g/L 7. Adequate hepatic and renal function, defined as: * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) * Creatinine clearance ≥ 60 mL/min 8. Signed informed consent obtained prior to any study-related procedures or treatments, confirming the patient's willingness to participate and comply with study requirements. Exclusion Criteria: 1. Prior treatment with an ADC after disease recurrence or metastasis; 2. Pregnant or breastfeeding women; 3. No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria; 4. Symptomatic brain parenchymal and/or leptomeningeal metastases with symptoms not adequately controlled by treatment; 5. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin; 6. Psychiatric disorders or other conditions that may interfere with patient compliance; 7. Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial/venous thromboembolic events; 8. Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment; 9. Known or suspected allergy to any study drug or its excipients; 10. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, Liaoning, China

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