Clinical trial · Interventional
Optimal Application Timing of ADC Drugs for Advanced Breast Cancer
A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer. Primary Objective: To compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer. Secondary Objectives: To compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antibody drug conjugate | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ADC followed by chemotherapy group
- description
- Patients will receive an ADC agent as second-line treatment until disease progression or unacceptable toxicity, followed by physician's choice of chemotherapy as third-line treatment
- interventionNames
- Drug: Antibody drug conjugate
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy followed by ADC group
- description
- Patients will receive physician's choice of chemotherapy as second-line treatment until disease progression or unacceptable toxicity, followed by an ADC agent as third-line treatment.
- interventionNames
- Drug: Antibody drug conjugate
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available