NCT07073755Recruiting
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 · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Hunan Cancer Hospital
- NCT number
- NCT07073755
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Jan 2023 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent diagnosis of other active malignancies (except non-melanoma skin cancer or in situ cervical cancer)
Other illness
- Known central nervous system disease requiring immediate local treatment (unless clinically stable)
- Poor general condition with an Eastern Cooperative Oncology Group (ECOG) performance status ≥2
Other
- Incomplete medical records or missing key clinical follow-up data
- Life expectancy estimated to be less than 6 months based on clinical judgment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.