Timing is everything: new trial seeks best sequence of targeted therapy for breast cancer
NCT ID NCT07657130
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 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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced HER2-negative 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 places running it
1 site. The list below names each one and where it is.
-
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.
Contacts and locations
Locations
-
Liaoning Cancer Hospital & Institute
RECRUITINGShenyang, Liaoning, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Anesthesia choice during breast surgery may influence cancer return years later
- Could a daily pill tame advanced breast cancer? new trial tests oral paclitaxel
- Dance therapy shows promise for breast cancer patients
- Can a laser on your ear cure insomnia in breast cancer patients?
- New real-world study tracks eribulin effectiveness in tough breast cancer cases
- New video series aims to break the silence on breast cancer and sex