Breast NeoplasmsPhase 3NCT07088263
Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer
A Phase 3 study testing Gemcitabine, Vinorelbine, Eribulin, or Utidelone in people with Breast Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Gemcitabine, Vinorelbine, Eribulin, or Utidelone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 24 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Uncontrolled or significant heart disease.
- Suspected ILD/non-infectious pneumonia.
- Active autoimmune disease or inflammatory disease (including inflammatory bowel disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510080
Zhong-yu Yuan, M.D., 86-20-87343794, yuanzhy@sysucc.org.cn
About this study
Official title: A Prospective, Multicenter Phase Ⅲ Clinical Trial of Adaptive Chemotherapy for Advanced Breast Cancer After Standard Treatment
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.
Read the detailed description
This is a prospective, multicenter phase Ⅲ clinical Trial. The objective of the study is to evaluate the efficacy and safety of adaptive chemotherapy vs. conventional chemotherapy in the treatment of advanced breast cancer progressive after standard treatment. 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 is designed to recruit up to 192 subjects.
- Conditions
- Breast Neoplasms
- Being tested
- Gemcitabine, Vinorelbine, Eribulin, or Utidelone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Vinorelbine, Eribulin, or UtideloneDrug
Gemcitabine, Vinorelbine, Eribulin, or Utidelone is recieved every 28 days. The chemotherapy interval is one cycle every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy repeated every 28 days | Experimental | Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone.
Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 28 days. Receives: Drug: Gemcitabine, Vinorelbine, Eribulin, or Utidelone |
| Chemotherapy repeated every 21 days | Active comparator | Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone.
Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 21 days. Receives: Drug: Gemcitabine, Vinorelbine, Eribulin, or Utidelone |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
progression-free survival (PFS): 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Sep 2025
- Primary completion24 Jul 2027 (estimated)
- Study completion24 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088263
- Sponsor's protocol ID
- SYSUCC-081
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Phase Ⅲ Clinical Trial of Adaptive Chemotherapy for Advanced Breast Cancer After Standard Treatment
- ClinicalTrials.gov ID
- NCT07088263
- Acronym / sponsor ID
- SYSUCC-081
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 24 Jul 2027 (estimated)
- Study completion
- 24 Jun 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicenter phase Ⅲ clinical Trial. The objective of the study is to evaluate the efficacy and safety of adaptive chemotherapy vs. conventional chemotherapy in the treatment of advanced breast cancer progressive after standard treatment. 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 is designed to recruit up to 192 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy repeated every 28 days | Experimental | Drug: Gemcitabine, Vinorelbine, Eribulin, or UtideloneChemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 28 days. |
| Chemotherapy repeated every 21 days | Active comparator | Drug: Gemcitabine, Vinorelbine, Eribulin, or UtideloneChemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine, Vinorelbine, Eribulin, or UtideloneGemcitabine, Vinorelbine, Eribulin, or Utidelone is recieved every 28 days. The chemotherapy interval is one cycle every 28 days. | Drug | Chemotherapy repeated every 21 days, Chemotherapy repeated every 28 days |
Primary outcome
progression-free survival (PFS)
Time frame: 12 months
progression-free survival (PFS): 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine, Vinorelbine, Eribulin, or Utidelone in people with Breast Neoplasms, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhong-yu Yuan, M.D. (China: +86 20 87343009, yuanzhy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.