Clinical trial · Interventional
Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer
A Prospective, Multicenter Phase Ⅲ Clinical Trial of Adaptive Chemotherapy for Advanced Breast Cancer After Standard Treatment
NCT07088263CI-TRIAL-00098832recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of advanced breast cancer progressive after standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Vinorelbine, Eribulin, or Utidelone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy repeated every 28 days
- description
- Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 28 days.
- interventionNames
- Drug: Gemcitabine, Vinorelbine, Eribulin, or Utidelone
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy repeated every 21 days
- description
- Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 21 days.
- interventionNames
- Drug: Gemcitabine, Vinorelbine, Eribulin, or Utidelone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.