Optimal Application Timing of ADC Drugs for Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antibody drug conjugate, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer Females. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
Overview
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.
Interventions
- Drug Antibody drug conjugate
The selection of ADC agents will be based on the patient's molecular subtype. For Hormone receptor (HR)+/HER2-low patients, anti-HER2 ADCs such as trastuzumab deruxtecan may be used. For HR+/HER2-zero patients, TROP-2-targeted ADCs such as sacituzumab govitecan are preferred. For HR-/HER2-low patients, either anti-HER2 ADCs or Trophoblast cell surface antigen 2 (TROP-2) ADCs may be considered. For HR-/HER2-zero patients, TROP-2 ADCs will be used. The specific ADC regimen will be determined at th - Drug Chemotherapy
The chemotherapy regimen will consist of standard second-line agents such as capecitabine, eribulin, vinorelbine, or gemcitabine. The specific chemotherapy regimen will be determined at the discretion of the investigators.
Primary outcome measures
- Progression-free survival 2 (PFS2) [Time frame: Up to approximately 20 months]
Secondary outcome measures (4)
- Overall Survival (OS) [Time frame: Up to approximately 40 months]
- Patient-Reported Outcomes (PROs) [Time frame: Up to approximately 20 months]
- Time to Progression (TTP) [Time frame: Up to approximately 20 months]
- Adverse event [Time frame: Up to approximately 20 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Liaoning Cancer Hospital & Institute — Shenyang
Identifiers
NCT: NCT07657130 · OPTIMA-BC