Adaptive chemotherapy for advanced breast cancer after standard treatment

Is this trial a fit for you?

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

What this trial studies

This is a prospective, multicenter Phase 3 trial randomizing up to 192 participants with advanced breast cancer that progressed after standard first-line therapy to adaptive chemotherapy versus conventional chemotherapy. Investigators will choose among gemcitabine, vinorelbine, eribulin, or utidelone based on guidelines, patient clinical status, preferences, and financial considerations. The trial's primary focus is on the efficacy and safety of the adaptive approach compared with standard care. Participants must meet standard eligibility criteria including ECOG 0–1, expected survival >3 months, prior specified therapies, and at least one measurable lesion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Understands and voluntarily signs the informed consent form.
* ECOG PS of 0 or 1.
* Expected survival: \>3 months
* Histologically or cytologically confirmed advanced invasive breast cancer.
* Histological type: HR+/HER2- or HR-/HER2-. HR positivity is defined as ER and/or PR expression in ≥1% of tumor cells by IHC. HER2 negativity is defined according to the ASCO-CAP HER2 guidelines: IHC intensity of 0 or 1+, or IHC intensity of 2+ with negative in situ hybridization results.
* Previous failure of first-line treatment for metastatic disease. For HR+/HER2- patients: at least received endocrine therapy combined with CDK4/6 inhibitors. TNBC patients at least received chemotherapy combined with PD-1 inhibitors (if PD-L1 CPS ≥1), or PARP inhibitor treatment (if germline BRCA mutations), except for TNBC patients with known germline BRCA mutations whom the attending physician deems them unable or unsuitable for PARP inhibitor treatment.
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
* Premenopausal women must use medically acceptable contraception during the study.
* Compliance with the study protocol.

Exclusion Criteria:

* The investigator considers that the presence of the following factors would be unfavorable to the subject's participation in the study or may affect protocol compliance, such as uncontrolled hypertension, persistent or active infection, etc.
* Persistent toxicities caused by previous anti-tumor treatment that have not improved to ≤ Grade 2 or baseline levels.
* Neoplastic spinal cord compression or active brain metastases.
* Significant third-space fluid retention (e.g., ascites or pleural effusion).
* Uncontrolled infection requiring treatment with intravenous antibiotic.
* Active or uncontrolled hepatitis B or hepatitis C virus infection.
* Uncontrolled or significant heart disease.
* Suspected ILD/non-infectious pneumonia.
* Active autoimmune disease or inflammatory disease (including inflammatory bowel disease.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhong-yu Yuan, M.D.
• Email: yuanzhy@sysucc.org.cn
• Phone: China: +86 20 87343009

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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.