HER2-negative Metastatic Breast Cancer
Conditions
Brief summary
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.
Detailed description
This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. The therapy regimen primarily including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study plans to recruit 10 subjects.
Interventions
DRUGGemcitabine, Vinorelbine, or Eribulin
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
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and severity of adverse events (AEs) | 12 months | Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters |
Countries
China
Outcome results
None listed