Clinical trial Recruiting at 1 site Observational Ages 18 and up

Treatment options after targeted therapy stops working in advanced breast cancer

Official title: 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

Run by Hunan Cancer Hospital · NCT07073755 · Data updated 2026-11-12

This study will see how well different treatments work for people with advanced breast cancer who have stopped responding to CDK4/6 inhibitors, PIK3CA inhibitors, or T-DXd.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorHunan Cancer Hospital
Academic / other
Drugs / interventionstrastuzumab, chemotherapy
Locations1 site (Changsha, Hunan)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedDecember 30, 2025
Study endsJune 1, 2026
Registry record updatedJuly 18, 2025
Trial IDNCT07073755 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with histologically confirmed advanced or metastatic breast cancer who progressed after prior CDK4/6 inhibitors, PIK3CA inhibitors, T-DXd, or similar targeted therapies and who started a subsequent systemic therapy with available follow-up data.

Probably not a fit

Patients with incomplete medical records, concurrent active non-skin malignancies, or rapidly progressing central nervous system disease requiring immediate local treatment are unlikely to benefit from inclusion.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This real-world observational project collects retrospective and prospective routine-care data on patients with advanced or metastatic breast cancer who progressed after targeted therapies such as CDK4/6 inhibitors, PIK3CA inhibitors, or trastuzumab deruxtecan (T-DXd). Researchers will record subsequent systemic treatments (chemotherapy, endocrine therapy, targeted agents, or combinations) and capture outcomes including progression-free survival, overall survival, objective response rate, and duration of response. Baseline patient and tumor characteristics, prior treatment history, and follow-up information will be gathered to explore prognostic and predictive factors. The dataset will be used to describe treatment patterns and to develop outcome-prediction models to help guide future sequencing decisions in routine clinical practice.

Why it matters

Potential benefit: If successful, the results could help doctors choose better next treatments after targeted therapy stops working, potentially prolonging survival or delaying progression.

How similar studies have gone: Similar real-world and registry studies have provided useful observational data on treatment patterns, but randomized evidence on optimal sequencing after these newer targeted agents remains limited.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hunan Cancer Hospital
    Changsha, Hunan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.