Health TrialsbyHealthPanel

Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer

ConditionsHER2-negative Breast CancerRecurrenceMetastasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/ HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender;

Plan to receive SKB264 monotherapy or combination therapy;

Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+/HER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease;

Voluntarily participate in the study, sign the informed consent form and demonstrate good compliance.

Disqualifiers

Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;

Patients who are currently participating in other interventional clinical studies;

Known allergy to the investigational drug or any of its components;

Pregnant or lactating women;

Trial population

Patients with Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SKB264 Monotherapy or Combination Therapy

    Drug

    The interventions in this study comprised SKB264 monotherapy or combination therapy involving SKB264. The specific combination regimens were determined based on real-world clinical practice.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: TNBC Cohort1 intervention
Group B: HR+/HER2- BC Cohort1 intervention

Trial outcomes

Primary outcomes

1

Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer

Time frame
Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.

Secondary outcomes

1

Real world progression free survival (rwPFS) of SKB264 monotherapy or combination therapy

Time frame
Time from initiation of SKB264 monotherapy or combination therapy to the first documented evidence of progression or death, whichever came first, assessed up to 24 weeks.
2

Duration of treatment (DOT) of SKB264 monotherapy or combination therapy

Time frame
Time from initiation of SKB264 monotherapy or combination therapy to its discontinuation, assessed up to 24 weeks.
3

Real world objective response rate (rwORR) of SKB264 monotherapy or combination therapy

Time frame
The proportion of patients who had a complete or partial response documented by imaging reports or by assessment of treating physician during the study treatment, which is approximately up to 24 weeks from the initiation of the study treatment.
4

Real world overall survival (rwOS) of SKB264 monotherapy or combination therapy

Time frame
Time from initiation of SKB264 monotherapy or combination therapy to death from any cause, assessed up to 48 weeks.

Other outcomes

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now