OncoMatch/Clinical Trials/NCT07657130
Optimal Application Timing of ADC Drugs for Advanced Breast Cancer
Official title: A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
Is NCT07657130 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Antibody drug conjugate and Chemotherapy for breast cancer females.
Treatment: Antibody drug conjugate · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: combination chemotherapy — first-line for advanced/metastatic disease
Completed first-line combination chemotherapy for advanced/metastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria
Cannot have received: antibody-drug conjugate
Prior treatment with an ADC after disease recurrence or metastasis
Lab requirements
Blood counts
anc ≥ 1.5 × 10⁹/l; platelets ≥ 90 × 10⁹/l; hemoglobin ≥ 90 g/l
Kidney function
creatinine clearance ≥ 60 ml/min
Liver function
total bilirubin ≤ 1.5 × uln; ast or alt ≤ 2.5 × uln (≤ 5 × uln for patients with liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07657130 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages