Clinical trial · Interventional
Adaptive Therapy for Post-Second-Line Advanced Breast Cancer
A Phase II Study of the Efficacy and Safety of Adaptive Therapy for Metastatic Refractory Breast Cancer
NCT06533722CI-TRIAL-00090782completedPhase 2ClinicalTrials.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 post-second-line metastatic breast cancer.
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 |
|---|---|---|---|
| HER2-negative Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Vinorelbine, or Eribulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Gemcitabine Gemcitabine 1000 mg/m\^2 IV on days 1 and 8, cycled every 33 days Vinorelbine 25 mg/m\^2 IV on days 1 and 8, cycled every 33 days Eribulin 1.4 mg/m\^2 IV on days 1 and 8, cycled every 33 days
- interventionNames
- Drug: Gemcitabine, Vinorelbine, or Eribulin
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- 12 months
- description
- The interval time from the date of initiation treatment after recruit to the date of the first documented disease progression or death due to any cause.
Secondary outcomes (1)
- measure
- Occurrence and severity of adverse events (AEs)
- timeFrame
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. * Minimum life expectancy 16 weeks. * Histologically or cytologically confirmed advanced invasive breast cancer. * Histological type: human epidermal growth factor receptor 2 (HER2) negative. * Prior failure of at least first-line treatment for metastatic disease. * 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: * Pregnant or breast feeding. * Uncontrolled medical problems. * Evidence of active acute or chronic infection. * Hepatic, renal, cardiac, or bone marrow dysfunction. * Concurrent malignancy or history of other malignancy within the last five years. * Patients were unable or unwilling to comply with program requirements. * Concurrent use of any other anti-cancer therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.