Adaptive therapy for advanced breast cancer after second-line treatment
A Phase II Study of the Efficacy and Safety of Adaptive Therapy for Metastatic Refractory Breast Cancer
This study is testing a personalized treatment approach for people with advanced HER2-negative breast cancer who haven't responded to earlier therapies to see if it can help them better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06533722 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the efficacy and safety of adaptive therapy in patients with HER2-negative metastatic breast cancer who have failed at least first-line treatment. The study will involve a single-arm approach where treatment regimens, including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on clinical guidelines and patient-specific factors. A total of 10 subjects will be recruited to assess the outcomes of this personalized treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are women with HER2-negative metastatic breast cancer who have experienced treatment failure after at least one prior line of therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have uncontrolled medical problems or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more tailored and effective treatment option for patients with advanced breast cancer.
How similar studies have performed: While adaptive therapy is a novel approach in this context, similar strategies have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhongyu Yuan, M.D. — Sun Yat-sen University
- Study coordinator: Zhongyu Yuan, M.D.
- Email: yuanzhy@sysucc.org.cn
- Phone: 862087342794
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.