Invasive Breast Cancer (Stage I-III)Phase 2NCT07801898
Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer
A Phase 2 study testing NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide in people with Invasive Breast Cancer (Stage I-III), run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
The goal of this investigator-initiated, open-label, phase II clinical trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, Ki67 > 20% invasive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Invasive Breast Cancer (Stage I-III)
- What is being tested?
- NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Mar 2029
- 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 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible patients were aged ≥18 years
- Histologically confirmed estrogen ER-positive, HER2-negative breast cancer with a Ki67 proliferation index >20%.
- ER-positivity was defined as nuclear staining in ≥1% of tumor cells by immunohistochemistry (IHC). HER2-negative disease was defined as an IHC score of 0 or 1+, or an IHC score of 2+ with negative fluorescence in situ hybridization(FISH).
- Patients were required to have stage I-III operable or locally advanced breast cancer according to the eighth edition of the American Joint Committee on Cancer staging system.
- Patients with clinically node-negative disease (cN0) were additionally required to have high-risk clinical features, including a primary tumor classified as cT2 or higher and/or a markedly elevated Ki67 proliferation index.
- Other inclusion criteria were the presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, adequate bone marrow and major organ function, and no previous systemic chemotherapy or endocrine therapy for breast cancer.
Who cannot join
- Previous chemotherapy or endocrine therapy for breast cancer;
- Pregnancy or lactation;
- Severe or uncontrolled infection;
- Clinically significant cardiovascular disease, including New York Heart Association class III or IV heart failure, unstable angina, or myocardial infarction within 6 months before enrollment;
- Left ventricular ejection fraction <50%;
- A history of organ transplantation requiring ongoing immunosuppressive therapy;
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- Known human immunodeficiency virus infection;
- A concurrent or previous malignancy that could interfere with the assessment of study outcomes;
- Psychiatric, cognitive, or other medical conditions that could impair treatment adherence or compliance with study procedures.
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
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Yanyan Hong, （86）0551-63869536, aydefyhyy@163.com
About this study
Official title: Phase II Clinical Trial Evaluating Neoadjuvant Endocrine Therapy Combined With Chemotherapy in the Treatment of ER-positive, HER2-negative Stage I-III Breast Cancer
The goal of this investigator-initiated, open-label, phase II clinical trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, Ki67 > 20% invasive breast cancer.
The main questions it aims to answer are:
Read more
What is the objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 criteria at the completion of neoadjuvant treatment?
What are the changes in Ki-67 proliferation index, pathological tumor response, pathological complete response (pCR) rate, disease-free survival (DFS), and safety profile?
Participants will receive standard anthracycline- and taxane-based chemotherapy with letrozole. The chemotherapy regimen was either six cycles of docetaxel, epirubicin, and cyclophosphamide (TEC) every 3 weeks or four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane (EC→T). The investigator could replace docetaxel or paclitaxel with nanoparticle albumin-bound paclitaxel (nab-paclitaxel), depending on the patient's clinical features and treatment tolerance.
Patients took letrozole 2.5 mg orally once daily throughout neoadjuvant systemic therapy. Premenopausal patients also received ovarian function suppression with leuprorelin acetate (3.75 mg) subcutaneously every 28 days, from the start of neoadjuvant treatment until definitive surgery. A safety assessment will be conducted for each treatment cycle in the patient. During the neoadjuvant therapy phase, tumor assessment will be performed at least after 4 cycles and preoperatively; postoperatively, assessments will be conducted every 3 months using imaging modalities to evaluate the tumor status until disease progression, death, or completion of 3 years postoperatively occurs. Following surgery, all patients will receive adjuvant therapy selected by the investigator based on their individual clinical condition.
Read the detailed description
The investigators assessed radiological response with contrast-enhanced breast magnetic resonance imaging (MRI) at baseline, after four cycles of therapy, and after neoadjuvant treatment but before surgery. Best radiological response was classified according to the RECIST version 1.1. Best percentage tumour reduction was the largest reduction in target-lesion size from baseline across serial MRI examinations. Positive values denoted shrinkage; negative values denoted growth. The investigators scheduled definitive surgery about 3-6 weeks after neoadjuvant therapy, once treatment-related toxicities had resolved adequately and the patient was medically fit. A multidisciplinary team chose the type and extent of surgery after considering pretreatment disease characteristics, radiological response, patient preference, and surgical feasibility.
Dedicated breast pathologists reviewed the pretreatment core-needle biopsies and postoperative surgical specimens according to institutional practice. They graded pathological response with the Miller-Payne system and recorded residual invasive tumour size and postoperative pathological stage (ypT and ypN). They assessed estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki67 by immunohistochemistry using standardized institutional procedures.
The treating team selected postoperative radiotherapy, endocrine therapy, and other systemic treatment according to pathological findings, recurrence risk, and current institutional and national guidelines. Follow-up then continued according to institutional practice until the predefined data cut-off of 15 July 2026.
- Conditions
- Invasive Breast Cancer (Stage I-III)
- Being tested
- NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolideDrug
Patients received NaCET consisting of standard anthracycline- and taxane-based chemotherapy administered concurrently with letrozole. The preferred chemotherapy regimen was TEC, comprising docetaxel, epirubicin, and cyclophosphamide, administered every 3 weeks for six cycles. A sequential EC→T regimen, consisting of four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane, was also permitted. At the investigator's discretion, nab-paclitaxel could be substituted for docetaxel or paclitaxel according to individual patient characteristics, treatment tolerance, and clinical considerations. Letrozole was administered orally at 2.5 mg once daily throughout the entire neoadjuvant chemotherapy period. Premenopausal patients additionally received ovarian function suppression with leuprorelin 3.75 mg subcutaneously every 28 days, beginning at initiation of neoadjuvant treatment and continuing throughout the preoperative treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Drug Group | Experimental | Not described Receives: Drug: NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR defined as the proportion of patients whose best radiological response during neoadjuvant treatment was complete response (CR) or partial response (PR) according to RECIST version 1.1.
Measured: At the end of Cycle 4 and prior to surgery (each cycle is 21 days)
Secondary outcomes (5)
pCR
pCR defined as no residual invasive disease in the breast or axillary lymph nodes (ypT0/is ypN0)
Measured: At time of definitive surgery (each cycle is 21 days)
Pathological Response
Pathological response defined as Miller-Payne grade 3-5
Measured: At time of definitive surgery (each cycle is 21 days)
Paired change in Ki67 between biopsy and surgery
The Ki-67 labeling index was visually assessed independently and in a blinded manner by two breast pathologists according to specific instructions. The average value obtained from both observers was used as the final value for each case. For pCR patients, the postoperative Ki-67 value was replaced by the minimum value of 0.01.
Measured: From baseline biopsy to definitive surgery (each cycle is 21 days)
Disease-Free Survival (DFS)
Disease-free survival (DFS) is defined as the time from definitive surgery to the first occurrence of invasive disease recurrence (local, regional, or distant), contralateral invasive breast cancer, or death from any cause. Patients alive without any of these events will be censored at the date of last known disease-free status. Tumor assessments will be performed every 3 months post-surgery for up to 3 years, using imaging modalities (MRI, CT, or ultrasound) as per clinical practice.
Measured: From definitive surgery to 36 months post-surgery (each cycle is 21 days)
Treatment-related adverse events (TRAEs)
Patient safety was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5.0) developed by the National Cancer Institute (NCI).
Measured: From first dose to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast Cancer (Stage I-III)Studies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan yan, Hong, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801898
- Sponsor's protocol ID
- YX2023-203（F1）
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial Evaluating Neoadjuvant Endocrine Therapy Combined With Chemotherapy in the Treatment of ER-positive, HER2-negative Stage I-III Breast Cancer
- ClinicalTrials.gov ID
- NCT07801898
- Acronym / sponsor ID
- YX2023-203（F1）
- Conditions
- Invasive Breast Cancer (Stage I-III)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 3 Sep 2026 (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 goal of this investigator-initiated, open-label, phase II clinical trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, Ki67 > 20% invasive breast cancer.
The main questions it aims to answer are:
What is the objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 criteria at the completion of neoadjuvant treatment?
What are the changes in Ki-67 proliferation index, pathological tumor response, pathological complete response (pCR) rate, disease-free survival (DFS), and safety profile?
Participants will receive standard anthracycline- and taxane-based chemotherapy with letrozole. The chemotherapy regimen was either six cycles of docetaxel, epirubicin, and cyclophosphamide (TEC) every 3 weeks or four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane (EC→T). The investigator could replace docetaxel or paclitaxel with nanoparticle albumin-bound paclitaxel (nab-paclitaxel), depending on the patient's clinical features and treatment tolerance.
Patients took letrozole 2.5 mg orally once daily throughout neoadjuvant systemic therapy. Premenopausal patients also received ovarian function suppression with leuprorelin acetate (3.75 mg) subcutaneously every 28 days, from the start of neoadjuvant treatment until definitive surgery. A safety assessment will be conducted for each treatment cycle in the patient. During the neoadjuvant therapy phase, tumor assessment will be performed at least after 4 cycles and preoperatively; postoperatively, assessments will be conducted every 3 months using imaging modalities to evaluate the tumor status until disease progression, death, or completion of 3 years postoperatively occurs. Following surgery, all patients will receive adjuvant therapy selected by the investigator based on their individual clinical condition.
Detailed description
The investigators assessed radiological response with contrast-enhanced breast magnetic resonance imaging (MRI) at baseline, after four cycles of therapy, and after neoadjuvant treatment but before surgery. Best radiological response was classified according to the RECIST version 1.1. Best percentage tumour reduction was the largest reduction in target-lesion size from baseline across serial MRI examinations. Positive values denoted shrinkage; negative values denoted growth. The investigators scheduled definitive surgery about 3-6 weeks after neoadjuvant therapy, once treatment-related toxicities had resolved adequately and the patient was medically fit. A multidisciplinary team chose the type and extent of surgery after considering pretreatment disease characteristics, radiological response, patient preference, and surgical feasibility.
Dedicated breast pathologists reviewed the pretreatment core-needle biopsies and postoperative surgical specimens according to institutional practice. They graded pathological response with the Miller-Payne system and recorded residual invasive tumour size and postoperative pathological stage (ypT and ypN). They assessed estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki67 by immunohistochemistry using standardized institutional procedures.
The treating team selected postoperative radiotherapy, endocrine therapy, and other systemic treatment according to pathological findings, recurrence risk, and current institutional and national guidelines. Follow-up then continued according to institutional practice until the predefined data cut-off of 15 July 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Drug Group | Experimental | Drug: NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Eligible patients were aged ≥18 years
- Histologically confirmed estrogen ER-positive, HER2-negative breast cancer with a Ki67 proliferation index >20%.
- ER-positivity was defined as nuclear staining in ≥1% of tumor cells by immunohistochemistry (IHC). HER2-negative disease was defined as an IHC score of 0 or 1+, or an IHC score of 2+ with negative fluorescence in situ hybridization(FISH).
- Patients were required to have stage I-III operable or locally advanced breast cancer according to the eighth edition of the American Joint Committee on Cancer staging system.
- Patients with clinically node-negative disease (cN0) were additionally required to have high-risk clinical features, including a primary tumor classified as cT2 or higher and/or a markedly elevated Ki67 proliferation index.
Key exclusion criteria (9 listed)
- Previous chemotherapy or endocrine therapy for breast cancer;
- Pregnancy or lactation;
- Severe or uncontrolled infection;
- Clinically significant cardiovascular disease, including New York Heart Association class III or IV heart failure, unstable angina, or myocardial infarction within 6 months before enrollment;
- Left ventricular ejection fraction <50%;
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 |
|---|---|---|
| NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolidePatients received NaCET consisting of standard anthracycline- and taxane-based chemotherapy administered concurrently with letrozole. The preferred chemotherapy regimen was TEC, comprising docetaxel, epirubicin, and cyclophosphamide, administered every 3 weeks for six cycles. A sequential EC→T regimen, consisting of four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane, was also permitted. At the investigator's discretion, nab-paclitaxel could be substituted for docetaxel or paclitaxel according to individual patient characteristics, treatment tolerance, and clinical considerations. Letrozole was administered orally at 2.5 mg once daily throughout the entire neoadjuvant chemotherapy period. Premenopausal patients additionally received ovarian function suppression with leuprorelin 3.75 mg subcutaneously every 28 days, beginning at initiation of neoadjuvant treatment and continuing throughout the preoperative treatment period. | Drug | Experimental Drug Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: At the end of Cycle 4 and prior to surgery (each cycle is 21 days)
ORR defined as the proportion of patients whose best radiological response during neoadjuvant treatment was complete response (CR) or partial response (PR) according to RECIST version 1.1.
5 secondary outcomes
pCR
Time frame: At time of definitive surgery (each cycle is 21 days)
Pathological Response
Time frame: At time of definitive surgery (each cycle is 21 days)
Paired change in Ki67 between biopsy and surgery
Time frame: From baseline biopsy to definitive surgery (each cycle is 21 days)
Disease-Free Survival (DFS)
Time frame: From definitive surgery to 36 months post-surgery (each cycle is 21 days)
Treatment-related adverse events (TRAEs)
Time frame: From first dose to 30 days after last dose
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes
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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 NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide in people with Invasive Breast Cancer (Stage I-III), run by The Second Hospital of Anhui Medical 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 6 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: opening soon, as of the sponsor's last update on 3 Sep 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?
Contact Yanyan Hong (（86）0551-63869536, aydefyhyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: At the end of Cycle 4 and prior to surgery (each cycle is 21 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 3 Sep 2026.