NCT07088263RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 20 Jul 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 24 Jul 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07088263
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 192
- From 15 Sept 2025 to the primary completion date, 24 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persistent toxicities caused by previous anti-tumor treatment that have not improved to ≤ Grade 2 or baseline levels.
- Uncontrolled infection requiring treatment with intravenous antibiotic.
Other illness
- 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.
- Active or uncontrolled hepatitis B or hepatitis C virus infection.
- Uncontrolled or significant heart disease.
- Active autoimmune disease or inflammatory disease (including inflammatory bowel disease.
Other
- Neoplastic spinal cord compression or active brain metastases.
- Significant third-space fluid retention (e.g., ascites or pleural effusion).
- Suspected ILD/non-infectious pneumonia.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.