Optimal timing of antibody drug conjugate therapy for advanced HER2-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized trial comparing two sequences of therapy for advanced HER2-negative breast cancer: an antibody-drug conjugate followed by chemotherapy versus chemotherapy followed by an ADC. Eligible participants are women aged 18-75 who have progressed after first-line treatment and have adequate organ function and performance status. Primary endpoint is progression-free survival after the second line of therapy (PFS2); secondary endpoints include overall survival, adverse events, patient-reported outcomes, cost-effectiveness, and biomarkers predicting benefit from frontline ADC therapy. The study is conducted at Liaoning Cancer Hospital & Institute in China, with collaboration from the National Cancer Center, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Liaoning Cancer Hospital & Institute
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Tao Sun — Liaoning Cancer Hospital & Institute
• Study coordinator: Dan Lyu
• Email: lvdan9303@163.com
• Phone: 0086-19800367870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.