A Real-World Observational Study on Post-Resistance Treatment Outcomes in Advanced Breast Cancer Patients After CDK4/6 Inhibitors, PIK3CA Inhibitors, or Trastuzumab Deruxtecan Therapy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including CDK4/6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted agents commonly used in clinical practice. As resistance to these therapies becomes increasingly common, optimal sequencing strategies for subsequent treatment remain unclear. This study will collect clinical information on post-resistance systemic treatments and their outcomes, including progression-free survival, overall survival, and response rate. Baseline patient and tumor characteristics will also be collected to explore potential prognostic and predictive factors and to develop outcome prediction models that may help guide future clinical decision-making. This is a non-interventional study based on retrospective and prospective data from routine medical care. The results are expected to provide real-world evidence to inform personalized treatment strategies for patients with advanced breast cancer following resistance to targeted therapies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18 years old) with histologically or cytologically confirmed advanced or metastatic breast cancer

• Received prior treatment with at least one of the following: CDK4/6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted therapies

• Documented disease progression following prior targeted therapy

• Initiated a subsequent line of systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or combination) after resistance

• Available clinical data including baseline characteristics and treatment details

• At least one follow-up evaluation after initiation of post-resistance therapy

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Contact Information
Primary
Binliang Liu, M.D
liubinliang_onco@163.com
+8617370789834
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 200
Treatments
Post-Resistance Advanced Breast Cancer Patients
This cohort includes patients with advanced or metastatic breast cancer who experienced disease progression after treatment with CDK4/6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted therapies. All patients subsequently received further systemic therapy, including chemotherapy, endocrine therapy, targeted agents, or their combinations, based on physician discretion and routine clinical practice. This observational cohort will be analyzed to assess treatment patterns, clinical outcomes (e.g., progression-free survival and overall survival), and potential prognostic or predictive factors.
Related Therapeutic Areas
Sponsors
Leads: Hunan Cancer Hospital

This content was sourced from clinicaltrials.gov