NCT07657130RecruitingPhase 2
A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
Liaoning Cancer Hospital & Institute1 site in 1 country120 target enrollmentStarted: July 1, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 18-75 years;
- •Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+/ISH-, IHC 1+/ISH-, and IHC 0/ISH- subtypes;
- •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);
- •Electrocorticography (ECOG) performance status < 2;
- •Estimated life expectancy ≥ 12 weeks;
- •Adequate bone marrow function, defined as:
- •ANC ≥ 1.5 × 10⁹/L
- •Platelets ≥ 90 × 10⁹/L
- •Hemoglobin ≥ 90 g/L
- •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
- •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
- •Prior treatment with an ADC after disease recurrence or metastasis;
- •Pregnant or breastfeeding women;
- •No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;
- •Symptomatic brain parenchymal and/or leptomeningeal metastases with symptoms not adequately controlled by treatment;
- •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;
- •Psychiatric disorders or other conditions that may interfere with patient compliance;
- •Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial/venous thromboembolic events;
- •Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment;
- •Known or suspected allergy to any study drug or its excipients;
- •Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.
Investigators
Tao Sun
Principal Investigator
Liaoning Cancer Hospital & Institute
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without DiabetesObesityNCT07521631Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.372
Not yet recruiting
Phase 2
Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian CancerNCT07432594Cancer Institute and Hospital, Chinese Academy of Medical Sciences82
Recruiting
Phase 2
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)Non-small Cell Lung CancerNCT07642024Sichuan Baili Pharmaceutical Co., Ltd.90
Not yet recruiting
Phase 2
Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable HepatocellularNCT07352007Lei ZHAO110
Enrolling By Invitation
Phase 3
A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell LymphomaNCT07348575Second Affiliated Hospital of Nanchang University80