Optimal Application Timing of ADC Drugs for Advanced Breast Cancer

ConditionBreast Cancer Females

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-75

SponsorLiaoning Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Antibody drug conjugate
Drug
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 the discretion of the investigators.
Chemotherapy
Drug
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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: ADC followed by chemotherapy groupExperimental treatment 2 interventions

Group B: Chemotherapy followed by ADC groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Progression-free survival 2 (PFS2)

Progression-free survival 2 (PFS2) is defined as the time from randomization to disease progression or death (whichever occurs first) following the second treatment.

Time frame

Up to approximately 20 months

Secondary outcomes

Overall Survival (OS)

Defined as the time from randomization to death from any cause.

Time frame

Up to approximately 40 months

Patient-Reported Outcomes (PROs)

Defined as reports directly from patients regarding their health status, functional status, and treatment experience during the period from randomization to disease progression, without interpretation by clinicians or others.

Time frame

Up to approximately 20 months

Time to Progression (TTP)

Defined as the time from randomization to disease progression.

Time frame

Up to approximately 20 months

Adverse event

Defined as the occurrence of adverse events after enrollment, evaluated according to NCI CTCAE version 5.0.

Time frame

Up to approximately 20 months

Other outcomes

Cost-effectiveness

Defined as the total treatment-related costs incurred after patient enrollment.

Time frame

Up to approximately 20 months

Exploratory Endpoint

The correlation between baseline tumor mutation burden level and progression-free survival 2 (PFS2).

Time frame

Up to approximately 20 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liaoning Cancer Hospital & Institute

Lead sponsor

National Cancer Center, China

Collaborator

Source ClinicalTrials.gov

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