HR+/HER2- Breast CancerPhase 2NCT06874933
Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
A Phase 2 study testing Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart in people with HR+/HER2- Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 3 sites in China.
Trial summary
Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR+/HER2- Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesChina
- Study dates
- 4 May 2025to 1 Apr 2030
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 and 75 years old.
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Patients with histologically or pathologically confirmed invasive ductal carcinoma of the breast, and simultaneously meeting the following conditions:
- T1c (≥1 cm) - 4c N0-2; Histologically confirmed as grade 3 by the research center; Immunohistochemical staining results confirm ER+ (≥1%), HER2 negative (Her2/neu fluorescence in situ hybridization (FISH) ratio ≤ 1.8 or IHC 0 or 1+); and the combined positive score (CPS) is greater than or equal to 10 points. The PD-L1 antibody site detected in our center is 22C3.
- Have not received any previous treatment.
- The functional levels of the major organs must meet the following requirements (no blood transfusion, and no use of drugs for increasing white blood cells or platelets within 2 weeks before screening):
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- Blood routine: Absolute neutrophil count (ANC) > 1.5×10⁹/L; platelet count (PLT) > 75× 10⁹/L; hemoglobin (Hb) > 90 g/L; lymphocyte count ≥ 1.5×10⁹/L.
- Blood biochemistry: Total bilirubin (TBIL) < 1.5× the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5×ULN; alkaline phosphatase < 2.5×ULN; blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) < 1.5×ULN.
- Echocardiogram: Left ventricular ejection fraction (LVEF) > 55%.
- 12-lead electrocardiogram: The corrected QT interval using the Fridericia method (QTcF) < 470 msec.
- For premenopausal female patients or those who have not undergone surgical sterilization: Use an effective contraceptive method during the treatment period and for at least 6 months after the last administration of the study treatment.
- Voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with the follow-up.
Who cannot join
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously receiving anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone-modifying drug therapy, or immune checkpoint inhibitor therapy.
- Having undergone a major surgical procedure unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such a surgical procedure.
- Severe heart diseases or disorders, including but not limited to the following diseases:
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- A confirmed history of heart failure or systolic dysfunction (left ventricular ejection fraction [LVEF] less than 50%).
- High-risk uncontrolled arrhythmias, such as atrial tachycardia with a resting heart rate greater than 100 beats per minute (bpm), significant ventricular arrhythmias (such as ventricular tachycardia), or higher-degree atrioventricular block (i.e., Mobitz type II second-degree atrioventricular block or third-degree atrioventricular block).
- Angina pectoris requiring treatment with anti-anginal drugs. Clinically significant valvular heart disease. Electrocardiogram (ECG) showing transmural myocardial infarction. Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg after drug treatment).
- Uncontrolled active infections that require treatment; a history of immunodeficiency, including a positive HIV test result, or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Patients with active chronic hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, patients with stable hepatitis B after drug treatment [negative HBV-DNA test or < 50 IU/ml], and cured hepatitis C patients [negative HCV RNA test]).
- Have previously received immunotherapy and experienced immune-related adverse events such as immune-related pneumonia or myocarditis, which, as determined by the investigator, may affect the safety of the study drug.
- Known history of allergy to the components of this treatment regimen.
- Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test result, or patients of childbearing age who are unwilling to use effective contraceptive measures throughout the trial period and within 6 months after the last administration of the study drug.
- Suffering from severe concomitant diseases or other comorbidities that may interfere with the planned treatment, or any other situation in which the investigator deems the patient unsuitable for participating in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
About this study
Official title: A Prospective, Single-Arm Clinical Study on the Treatment of HR+/HER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody
Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
- Conditions
- HR+/HER2- Breast Cancer
- Being tested
- Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart
- Keywords
- Breast cancer, Anlotinib and Benmelstobart, Adjuvant Chemotherapy, HR-positive HER2-negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy in Combination with Anlotinib and BenmelstobartDrug
Group A: Epirubicin + cyclophosphamide + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by nab-paclitaxel + Benmelstobart administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is simultaneously combined. It is taken orally once a day, before breakfast. Take the medicine continuously for two weeks, then stop taking it for one week. One cycle is 21 days, and there are a total of 3 cycles.
Group B: Nab-paclitaxel + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by Epirubicin + cyclophosphamide + Benmelstobart, which are administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is also used in combination. It should be taken orally once a day before breakfast, continuously for two weeks, then stop taking it for one week.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Neoadjuvant Chemotherapy(EC-T) in Combination with Anlotinib and Benmelstobart | Experimental | Epirubicin + cyclophosphamide + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks), followed by nab-paclitaxel + Benmelstobart administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks). During the treatment period, Anlotinib is simultaneously combined. It is taken orally once a day, before breakfast. Take the medicine continuously for two weeks, then stop taking it for one week. A cycle is 21 days, and there are a total of 3 cycles. Receives: Drug: Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart |
| Group B: Neoadjuvant Chemotherapy(T-EC) in Combination with Anlotinib and Benmelstobart | Experimental | Nab-paclitaxel + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks), followed by Epirubicin + cyclophosphamide + Benmelstobart, which are administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks). During the treatment period, Anlotinib is also used in combination. It should be taken orally once a day before breakfast, continuously for two weeks, then stop taking it for one week. One cycle is 21 days, and there are a total of 3 cycles. Receives: Drug: Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response（PCR）
The primary study objective is to evaluate the pathologic complete response（PCR） of neoadjuvant treatment of HR+/HER2- breast cancer with Anlotinib and Benmelstobart
Measured: 2 years
RCB 0-1 Ratio
In clinical trials comparing different neoadjuvant treatment regimens, the RCB 0 - 1 Ratio is a crucial evaluation indicator. For example, in a study comparing a traditional chemotherapy regimen with a novel targeted combination chemotherapy regimen, by observing the differences in the RCB 0 - 1 Ratio between the two groups of patients, it can be determined which regimen enables more patients to reach the RCB 0 or RCB 1 status, thus providing a basis for selecting a better treatment option.
Measured: 2 years
Secondary outcomes (1)
Event Free Survival（EFS)
Event Free Survival (EFS) refers to the time from the start of randomization (the start of treatment in a single-arm trial) to the first occurrence of any of the following events: disease progression that makes surgical treatment impossible, local or distant recurrence, death due to any cause, etc. It can be used to evaluate the effectiveness of the drug.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start4 May 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874933
- Sponsor's protocol ID
- IIT20240164C
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Clinical Study on the Treatment of HR+/HER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT06874933
- Acronym / sponsor ID
- IIT20240164C
- Conditions
- HR+/HER2- Breast Cancer
- Keywords
- Breast cancer, Anlotinib and Benmelstobart, Adjuvant Chemotherapy, HR-positive HER2-negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 4 May 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 13 Mar 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.
Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Neoadjuvant Chemotherapy(EC-T) in Combination with Anlotinib and Benmelstobart | Experimental | Drug: Neoadjuvant Chemotherapy in Combination with Anlotinib and BenmelstobartEpirubicin + cyclophosphamide + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks), followed by nab-paclitaxel + Benmelstobart administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks). During the treatment period, Anlotinib is simultaneously combined. It is taken orally once a day, before breakfast. Take the medicine continuously for two weeks, then stop taking it for one week. A cycle is 21 days, and there are a total of 3 cycles. |
| Group B: Neoadjuvant Chemotherapy(T-EC) in Combination with Anlotinib and Benmelstobart | Experimental | Drug: Neoadjuvant Chemotherapy in Combination with Anlotinib and BenmelstobartNab-paclitaxel + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks), followed by Epirubicin + cyclophosphamide + Benmelstobart, which are administered by intravenous drip once every 3 weeks for a total of 2 cycles (6 weeks). During the treatment period, Anlotinib is also used in combination. It should be taken orally once a day before breakfast, continuously for two weeks, then stop taking it for one week. One cycle is 21 days, and there are a total of 3 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female patients aged between 18 and 75 years old.
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Patients with histologically or pathologically confirmed invasive ductal carcinoma of the breast, and simultaneously meeting the following conditions:
- T1c (≥1 cm) - 4c N0-2; Histologically confirmed as grade 3 by the research center; Immunohistochemical staining results confirm ER+ (≥1%), HER2 negative (Her2/neu fluorescence in situ hybridization (FISH) ratio ≤ 1.8 or IHC 0 or 1+); and the combined positive score (CPS) is greater than or equal to 10 points. The PD-L1 antibody site detected in our center is 22C3.
- Have not received any previous treatment.
Key exclusion criteria (15 listed)
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously receiving anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone-modifying drug therapy, or immune checkpoint inhibitor therapy.
- Having undergone a major surgical procedure unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such a surgical procedure.
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 |
|---|---|---|
| Neoadjuvant Chemotherapy in Combination with Anlotinib and BenmelstobartGroup A: Epirubicin + cyclophosphamide + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by nab-paclitaxel + Benmelstobart administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is simultaneously combined. It is taken orally once a day, before breakfast. Take the medicine continuously for two weeks, then stop taking it for one week. One cycle is 21 days, and there are a total of 3 cycles. Group B: Nab-paclitaxel + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by Epirubicin + cyclophosphamide + Benmelstobart, which are administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is also used in combination. It should be taken orally once a day before breakfast, continuously for two weeks, then stop taking it for one week. | Drug | Group A: Neoadjuvant Chemotherapy(EC-T) in Combination with Anlotinib and Benmelstobart, Group B: Neoadjuvant Chemotherapy(T-EC) in Combination with Anlotinib and Benmelstobart |
Primary outcome
pathologic complete response（PCR）
Time frame: 2 years
The primary study objective is to evaluate the pathologic complete response（PCR） of neoadjuvant treatment of HR+/HER2- breast cancer with Anlotinib and Benmelstobart
RCB 0-1 Ratio
Time frame: 2 years
In clinical trials comparing different neoadjuvant treatment regimens, the RCB 0 - 1 Ratio is a crucial evaluation indicator. For example, in a study comparing a traditional chemotherapy regimen with a novel targeted combination chemotherapy regimen, by observing the differences in the RCB 0 - 1 Ratio between the two groups of patients, it can be determined which regimen enables more patients to reach the RCB 0 or RCB 1 status, thus providing a basis for selecting a better treatment option.
1 secondary outcome
Event Free Survival（EFS)
Time frame: 3 years
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 12 Aug 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart in people with HR+/HER2- Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 3 sites 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 12 inclusion and 15 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Zhijun Dai, Professor (+86 157 0581 9132, dzj0911@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response（PCR） (time frame: 2 years). The study lists 2 primary outcomes in all. 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 12 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.