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Clinical Trials in China / NCT07073755
Recruiting Observational

Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd

NCT07073755 · tracked via the Priya Life Science China tracker
Sponsor
Hunan Cancer Hospital
Phase
Observational
Started
2023-01-01
Last updated
2025-07-18

Condition(s) studied

Metastatic Breast CancerDrug ResistanceHormone Receptor-Positive Breast CancerHER2-positive Breast CancerTriple-Negative Breast Cancer (TNBC)Treatment Decisions

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — From the start of post-resistance systemic treatment until documented disease progression or death, up to 36 months.
    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.

Trial sites (1)

FacilityCityRegionStatus
Hunan Cancer Hospital Changsha Hunan Recruiting

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Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer Recruiting
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T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073755 on ClinicalTrials.gov ↗ ← All trials in China