Clinical trial · Observational
Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Resistance | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Hormone Receptor-Positive Breast Cancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Treatment Decisions | — | UNRESOLVED | — |
| Triple-Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Post-Resistance Advanced Breast Cancer Patients
- description
- 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.
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From the start of post-resistance systemic treatment until documented disease progression or death, up to 36 months.
- description
- Progression-Free Survival (PFS) is defined as the time from the initiation of post-progression systemic treatment (after resistance to CDK4/6 inhibitors, PIK3CA inhibitors, T-DXd, or other targeted therapies) to the date of documented disease progression or death from any cause, whichever occurs first. Disease progression will be determined based on radiological or clinical assessment, as per real-world documentation standards. Patients without progression or death at the time of analysis will be censored at the date of last follow-up.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults (≥18 years old) with histologically or cytologically confirmed advanced or metastatic breast cancer 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: 1. Incomplete medical records or missing key clinical follow-up data 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
References
Publications (0)
Data not yet available