Adaptive chemotherapy for advanced breast cancer after standard treatment
A Prospective, Multicenter Phase Ⅲ Clinical Trial of Adaptive Chemotherapy for Advanced Breast Cancer After Standard Treatment
This tests whether tailoring chemotherapy choices (gemcitabine, vinorelbine, eribulin, or utidelone) can improve outcomes for people whose advanced breast cancer has progressed after standard treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07088263 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed advanced HR+/HER2- or HR-/HER2- breast cancer who progressed after first-line therapy, have ECOG 0–1, expected survival over three months, prior specified systemic treatments, and at least one measurable lesion.
Not a fit: Patients unlikely to benefit include those with HER2-positive disease, ECOG performance status >1, early-stage disease or who have not yet progressed on standard first-line therapy, or those medically ineligible for the study drugs.
Why it matters
Potential benefit: If successful, adaptive selection of chemotherapy could prolong disease control and better balance benefit versus side effects by matching treatment to each patient's situation.
How similar studies have performed: Adaptive therapy strategies have shown promising signals in some cancer settings but are not yet established in advanced breast cancer, while the individual drugs used are established chemotherapy agents.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.