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Trial Title:
Adaptive Therapy for Post-Second-Line Advanced Breast Cancer
NCT ID:
NCT06533722
Condition:
HER2-negative Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Gemcitabine
Vinorelbine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine, Vinorelbine, or Eribulin
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
Arm group label:
Treatment arm
Other name:
chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhong-yu Yuan, MD
Phone:
86-20-87343794
Email:
yuanzhy@sysucc.org.cn
Start date:
August 4, 2024
Completion date:
July 7, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533722
