NCT07073755 Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd
| NCT ID | NCT07073755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hunan Cancer Hospital |
| Condition | Metastatic Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07073755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07073755 currently recruiting?
Yes, NCT07073755 is actively recruiting participants. Contact the research team at liubinliang_onco@163.com for enrollment information.
Where is the NCT07073755 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07073755 clinical trial?
NCT07073755 is sponsored by Hunan Cancer Hospital. The trial plans to enroll 200 participants.
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