Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd
NCT ID: NCT07073755
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2023-01-01
2026-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
NCT06033287
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
NCT06791161
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
NCT04494425
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
NCT06344793
A Phase II Study to Evaluate the Efficacy and Safety of Anti-HER2 Triple-targeted Drugs Combined With CDK4/6 Inhibitors in Neoadjuvant Therapy for ER-positive HER2-positive Breast Cancer Patients.
NCT07290166
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This real-world observational study aims to investigate the treatment patterns and clinical outcomes of patients with advanced or metastatic breast cancer who experience disease progression after receiving CDK4/6 inhibitors, PIK3CA inhibitors, T-DXd, or other relevant targeted agents. The study will focus on characterizing the effectiveness of subsequent treatment regimens, including chemotherapy, endocrine therapy, additional targeted therapies, or their combinations.
In addition to evaluating clinical outcomes such as progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and duration of response (DoR), the study will collect detailed baseline patient characteristics, tumor biological features, and prior treatment histories. These data will be used to identify potential prognostic and predictive factors and to develop outcome prediction models that may support personalized treatment planning in the post-resistance setting.
Patients will be identified based on medical record review, with retrospective and/or prospective data collection depending on institutional capabilities. Treatment decisions are made at the discretion of the treating physicians as part of standard clinical care. The study does not involve any experimental intervention, and no additional diagnostic or therapeutic procedures will be imposed on participants.
The ultimate goal of this study is to generate clinically relevant, real-world evidence to guide optimal treatment sequencing after resistance to targeted therapy in advanced breast cancer, and to support future clinical research and decision-making frameworks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Received prior treatment with at least one of the following: CDK4/6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted therapies
3. Documented disease progression following prior targeted therapy
4. Initiated a subsequent line of systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or combination) after resistance
5. Available clinical data including baseline characteristics and treatment details
6. At least one follow-up evaluation after initiation of post-resistance therapy
Exclusion Criteria
2. Concurrent diagnosis of other active malignancies (except non-melanoma skin cancer or in situ cervical cancer)
3. Known central nervous system disease requiring immediate local treatment (unless clinically stable)
4. Poor general condition with an Eastern Cooperative Oncology Group (ECOG) performance status ≥2
5. Life expectancy estimated to be less than 6 months based on clinical judgment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hunan Cancer Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hunan Cancer Hospital
Changsha, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HNCA-PoReBC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.