New adaptive chemo strategy aims to outsmart advanced breast cancer
NCT ID NCT07088263
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way of giving chemotherapy called adaptive therapy for people with advanced breast cancer that has gotten worse after standard treatments. The goal is to see if adjusting the dose over time can help control the cancer longer and with fewer side effects. About 192 adults with specific types of breast cancer (HR+/HER2- or HR-/HER2-) will take part. The main focus is on how long the cancer stays under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Persistent toxicities caused by previous anti-tumor treatment that have not improved to ≤ Grade 2 or baseline levels. * Neoplastic spinal cord compression or active brain metastases. * Significant third-space fluid retention (e.g., ascites or pleural effusion). * Uncontrolled infection requiring treatment with intravenous antibiotic. * Active or uncontrolled hepatitis B or hepatitis C virus infection. * Uncontrolled or significant heart disease. * Suspected ILD/non-infectious pneumonia. * Active autoimmune disease or inflammatory disease (including inflammatory bowel disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510080, China
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Other studies related to the condition(s) this trial covers.
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