Breast CancerPhase 2NCT05728268
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
A Phase 2 study testing dose-dense nab-paclitaxel followed by EC in people with Breast Cancer, run by Shantou Central Hospital at 1 site in China.
Trial summary
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dose-dense nab-paclitaxel followed by EC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Dec 2025
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with age of 18 to 70 years old.
- Newly diagnosed breast cancer patients.
- Planned neoadjuvant chemotherapy.
- Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.
- HER2/neu-negative.
- Ki67≥30%.
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- Clinical stage IIB-IIIC.
- Informed consent form understood and signed.
- Patient agrees to all follow-up visits.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Women of childbearing potential must have a negative serum pregnancy test.
Who cannot join
- Metastatic disease
- Pregnancy.
- Nursing mothers.
- Active or uncontrolled infection.
- Presence of another malignancies.
- Granulocyte count < 1.5*10^9/L.
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- Platelet count < 100*10^9/L.
- Hemoglobin < 90g/L.
- Serum Creatinine more than 1.5 upper limit.
- AST and ALT more than 2.5 upper limit.
- LVEF< 50%.
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
Shantou Central Hospital
Shantou, Guangdong, 510000
Haitong Lyu, +8613631403739, heton25@foxmali.com
About this study
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- dose-dense nab-paclitaxel followed by EC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose-dense nab-paclitaxel followed by ECDrug
dose-dense nab-paclitaxel followed by EC
| Study group | Role | What they receive |
|---|---|---|
| dose-dense arm | Experimental | Not described Receives: Drug: dose-dense nab-paclitaxel followed by EC |
What is being measured
The primary outcome is the main question the study is designed to answer.
RCB
Residual Cancer Burden
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Aug 2021
- Primary completion30 Dec 2024
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shantou University Medical College, Jieyang People's Hospital
- Responsible party
- Principal investigator, Zhiyong Wu, Shantou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728268
- Sponsor's protocol ID
- ShantouCH02
- Status last verified
- Dec 2025
- First submitted
- 4 Feb 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
- ClinicalTrials.gov ID
- NCT05728268
- Acronym / sponsor ID
- ShantouCH02
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shantou Central HospitalUniversity, hospital or other
- Collaborators
- Shantou University Medical College, Jieyang People's Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Feb 2023 (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.
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose-dense arm | Experimental | Drug: dose-dense nab-paclitaxel followed by EC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females with age of 18 to 70 years old.
- Newly diagnosed breast cancer patients.
- Planned neoadjuvant chemotherapy.
- Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.
- HER2/neu-negative.
Key exclusion criteria (11 listed)
- Metastatic disease
- Pregnancy.
- Nursing mothers.
- Active or uncontrolled infection.
- Presence of another malignancies.
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 |
|---|---|---|
| dose-dense nab-paclitaxel followed by ECdose-dense nab-paclitaxel followed by EC | Drug | dose-dense arm |
Primary outcome
RCB
Time frame: 7 days
Residual Cancer Burden
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 2 Jan 2026.
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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 2 study testing dose-dense nab-paclitaxel followed by EC in people with Breast Cancer, run by Shantou Central Hospital 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 11 inclusion and 11 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 2 Jan 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RCB (time frame: 7 days). 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 2 Jan 2026.