Breast CancerPhase 2NCT07782840
QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI) and CDK4/6 inhibitor in people with Breast Cancer, run by Hebei Medical University Fourth Hospital.
Trial summary
This study will evaluate whether adding QL1706 (iparomlimab and tuvonralimab) to neoadjuvant endocrine therapy improves tumor response in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer who have had a poor response to neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI) and CDK4/6 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- 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 participants aged 18 to 75 years.
- Histologically or pathologically confirmed HR-positive/HER2-negative early or locally advanced breast cancer, classified as stage IIB-IIIC, with a poor response to two cycles of neoadjuvant TAC chemotherapy. Chemotherapy sensitivity is defined as a reduction in tumor size of at least 40% on magnetic resonance imaging (MRI), whereas a poor response is defined as a reduction in tumor size of less than 40%.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- No prior antitumor treatment other than the two cycles of neoadjuvant TAC chemotherapy specified in this study, including no prior immune checkpoint inhibitor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
Show all 11Show fewer
- No coagulation abnormalities.
- Normal cardiac function, a normal electrocardiogram, and a left ventricular ejection fraction of at least 55%.
- Willingness to provide tumor tissue and/or blood samples at baseline and after treatment for biomarker analyses. Participants with insufficient tumor tissue or those unwilling to provide biological samples may be enrolled only with the investigator's approval.
- Adequate major organ function, as defined by the following laboratory criteria: absolute neutrophil count greater than 1.5 × 10^9/L; platelet count greater than 100 × 10^9/L; hemoglobin greater than 100 g/L; total serum bilirubin less than 1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase less than 3 × ULN; and serum creatinine no greater than 1.5 × ULN.
- Ability to understand and comply with the study requirements and willingness to provide written informed consent.
Who cannot join
- Known hypersensitivity to any study drug or any of its excipients.
- Inflammatory breast cancer, bilateral breast cancer, or advanced breast cancer with distant metastases.
- A history of another malignancy within the past 5 years, except for malignancies treated with curative intent.
- Serious concomitant diseases, including extensive interstitial pneumonitis requiring pharmacological treatment; active or uncontrolled infection, including tuberculosis or human immunodeficiency virus infection; decompensated liver disease; active hepatitis; active bleeding; a history of cerebrovascular events or pulmonary embolism; active, known, or suspected autoimmune disease; or an active infection currently requiring systemic anti-infective therapy.
- Active brain metastases or leptomeningeal metastases, unless the metastases have been treated and are stable.
- Pregnancy, planned pregnancy, or breastfeeding.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of QL1706 Combined With Neoadjuvant Endocrine Therapy in Patients With HR-Positive/HER2-Negative Breast Cancer Showing a Poor Response to Neoadjuvant Chemotherapy: A Prospective, Randomized Controlled Clinical Trial
This study will evaluate whether adding QL1706 (iparomlimab and tuvonralimab) to neoadjuvant endocrine therapy improves tumor response in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer who have had a poor response to neoadjuvant chemotherapy.
Approximately 40 participants whose tumors have decreased by less than 40% on magnetic resonance imaging after two cycles of neoadjuvant TAC chemotherapy will be randomly assigned in a 1:1 ratio to receive either an aromatase inhibitor plus a CDK4/6 inhibitor or the same treatment combined with QL1706. Premenopausal and perimenopausal participants will also receive ovarian function suppression.
The main outcome is the objective response rate during the study treatment period. Pathological response, changes in Ki-67, treatment safety, and changes in the tumor immune microenvironment will also be evaluated.
Read the detailed description
Patients with HR-positive/HER2-negative breast cancer may have an inadequate response to neoadjuvant chemotherapy, and an optimal subsequent neoadjuvant treatment strategy for this population has not been established. QL1706 is a bifunctional combination antibody consisting of iparomlimab, which targets programmed cell death protein 1 (PD-1), and tuvonralimab, which targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Simultaneous inhibition of these immune checkpoints may enhance antitumor immune activity. This study will explore whether the addition of QL1706 to endocrine therapy and CDK4/6 inhibition improves tumor response in patients who have had a poor early response to neoadjuvant chemotherapy.
This is an exploratory, open-label, prospective, randomized controlled study. Approximately 40 women with stage IIB-IIIC HR-positive/HER2-negative early or locally advanced breast cancer will be enrolled. Eligible participants must have received two cycles of neoadjuvant TAC chemotherapy and have a reduction in tumor size of less than 40% on magnetic resonance imaging. Participants will be randomly assigned in a 1:1 ratio to the experimental arm or the active comparator arm.
Participants in the active comparator arm will receive an aromatase inhibitor plus a CDK4/6 inhibitor. Participants in the experimental arm will receive the same treatment combined with QL1706 at 5 mg/kg by intravenous infusion on Day 1 of each 3-week cycle for six cycles. Premenopausal and perimenopausal participants will receive ovarian function suppression. Surgery will be performed after completion of neoadjuvant treatment based on clinical assessment.
The primary outcome is the objective response rate according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary outcomes include breast pathological complete response, total pathological complete response, Miller-Payne grade, residual cancer burden class, changes in Ki-67 expression, and the incidence of immune-related and other adverse events. Exploratory analyses will assess changes in the tumor immune microenvironment, including immune-cell infiltration and the expression of PD-1, programmed death-ligand 1, and CTLA-4, using blood and tumor specimens collected at protocol-specified time points.
- Conditions
- Breast Cancer
- Being tested
- Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI), CDK4/6 inhibitor, Ovarian function suppression
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab (QL1706)Drug
Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at 5 mg/kg on Day 1 of each 3-week cycle for six cycles.
Aromatase Inhibitor (AI)Drug
Also called Exemestane, Anastrozole, Letrozole
Participants will receive exemestane, anastrozole, or letrozole. The specific aromatase inhibitor, dose, and administration schedule will be selected according to the applicable prescribing information or clinical guidelines and will be continued throughout the approximately 18-week neoadjuvant treatment period.
CDK4/6 inhibitorDrug
Also called Abemaciclib, Ribociclib
Participants will receive abemaciclib or ribociclib. The specific CDK4/6 inhibitor, dose, and administration schedule will be selected according to the applicable prescribing information or clinical guidelines and will be continued throughout the approximately 18-week neoadjuvant treatment period.
Ovarian function suppressionDrug
Also called Goserelin, Leuprorelin, Triptorelin
Premenopausal and perimenopausal participants will receive ovarian function suppression with goserelin, leuprorelin, or triptorelin. The specific agent, dose, and administration schedule will follow the applicable prescribing information or clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 Plus Endocrine Therapy | Experimental | Participants will receive an aromatase inhibitor plus a CDK4/6 inhibitor and QL1706. QL1706 will be administered intravenously at 5 mg/kg on Day 1 of each 3-week cycle for six cycles. The aromatase inhibitor and CDK4/6 inhibitor will be administered according to their respective prescribing information or applicable clinical guidelines throughout the neoadjuvant treatment period. Premenopausal and perimenopausal participants will also receive ovarian function suppression. Receives: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: Aromatase Inhibitor (AI); Drug: CDK4/6 inhibitor; Drug: Ovarian function suppression |
| Endocrine Therapy | Active comparator | Participants will receive an aromatase inhibitor plus a CDK4/6 inhibitor according to the respective prescribing information or applicable clinical guidelines throughout the neoadjuvant treatment period. Premenopausal and perimenopausal participants will also receive ovarian function suppression. Receives: Drug: Aromatase Inhibitor (AI); Drug: CDK4/6 inhibitor; Drug: Ovarian function suppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of participants whose best overall response is complete response (CR) or partial response (PR), as assessed by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR will be calculated as the number of participants achieving CR or PR divided by the total number of participants included in the efficacy analysis, multiplied by 100%.
Measured: From randomization through the preoperative assessment after six treatment cycles, approximately 18 weeks
Secondary outcomes (6)
Breast Pathological Complete Response Rate (bpCR)
Measured: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Total Pathological Complete Response Rate (tpCR)
Measured: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Miller-Payne Grade
Pathological response of the primary breast tumor will be assessed using the Miller-Payne grading system, which ranges from Grade 1 to Grade 5. Grade 1 indicates no or minimal reduction in tumor cells, whereas Grade 5 indicates no identifiable malignant cells at the primary tumor site. A higher grade indicates a better pathological response to treatment.
Measured: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Residual Cancer Burden (RCB) Class
Residual cancer burden will be assessed in the resected breast and regional lymph nodes and classified as RCB-0, RCB-I, RCB-II, or RCB-III. RCB-0 indicates no residual invasive cancer, whereas RCB-III indicates extensive residual disease. A higher RCB class indicates a greater residual tumor burden and a worse pathological response to treatment.
Measured: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Incidence of Immune-Related Adverse Events
Measured: From the first dose of study treatment through 30 days after the last dose, approximately 22 weeks
Change From Baseline in Ki-67 Expression
Ki-67 expression will be assessed by immunohistochemistry in tumor tissue obtained at baseline and at surgery and reported as the percentage of positively stained tumor cells (range, 0% to 100%). Change from baseline will be calculated as the value at surgery minus the baseline value and reported in percentage points (possible range, -100 to 100). A negative value indicates a reduction in Ki-67 expression, with a more negative value indicating greater suppression of tumor cell proliferation.
Measured: From baseline to surgery after completion of six treatment cycles, approximately 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly assigned in a 1:1 ratio to two parallel treatment arms. The experimental arm will receive an aromatase inhibitor plus a CDK4/6 inhibitor and QL1706, whereas the active comparator arm will receive an aromatase inhibitor plus a CDK4/6 inhibitor.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Ma, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782840
- Sponsor's protocol ID
- 2026KY043
- Other IDs
- LH20250010
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the data contain confidential clinical and biomarker information and are subject to participant privacy, informed consent, and ethics requirements. Aggregated study results will be reported through the ClinicalTrials.gov registry and scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of QL1706 Combined With Neoadjuvant Endocrine Therapy in Patients With HR-Positive/HER2-Negative Breast Cancer Showing a Poor Response to Neoadjuvant Chemotherapy: A Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07782840
- Acronym / sponsor ID
- 2026KY043
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 24 Aug 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.
This study will evaluate whether adding QL1706 (iparomlimab and tuvonralimab) to neoadjuvant endocrine therapy improves tumor response in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer who have had a poor response to neoadjuvant chemotherapy.
Approximately 40 participants whose tumors have decreased by less than 40% on magnetic resonance imaging after two cycles of neoadjuvant TAC chemotherapy will be randomly assigned in a 1:1 ratio to receive either an aromatase inhibitor plus a CDK4/6 inhibitor or the same treatment combined with QL1706. Premenopausal and perimenopausal participants will also receive ovarian function suppression.
The main outcome is the objective response rate during the study treatment period. Pathological response, changes in Ki-67, treatment safety, and changes in the tumor immune microenvironment will also be evaluated.
Detailed description
Patients with HR-positive/HER2-negative breast cancer may have an inadequate response to neoadjuvant chemotherapy, and an optimal subsequent neoadjuvant treatment strategy for this population has not been established. QL1706 is a bifunctional combination antibody consisting of iparomlimab, which targets programmed cell death protein 1 (PD-1), and tuvonralimab, which targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Simultaneous inhibition of these immune checkpoints may enhance antitumor immune activity. This study will explore whether the addition of QL1706 to endocrine therapy and CDK4/6 inhibition improves tumor response in patients who have had a poor early response to neoadjuvant chemotherapy.
This is an exploratory, open-label, prospective, randomized controlled study. Approximately 40 women with stage IIB-IIIC HR-positive/HER2-negative early or locally advanced breast cancer will be enrolled. Eligible participants must have received two cycles of neoadjuvant TAC chemotherapy and have a reduction in tumor size of less than 40% on magnetic resonance imaging. Participants will be randomly assigned in a 1:1 ratio to the experimental arm or the active comparator arm.
Participants in the active comparator arm will receive an aromatase inhibitor plus a CDK4/6 inhibitor. Participants in the experimental arm will receive the same treatment combined with QL1706 at 5 mg/kg by intravenous infusion on Day 1 of each 3-week cycle for six cycles. Premenopausal and perimenopausal participants will receive ovarian function suppression. Surgery will be performed after completion of neoadjuvant treatment based on clinical assessment.
The primary outcome is the objective response rate according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary outcomes include breast pathological complete response, total pathological complete response, Miller-Payne grade, residual cancer burden class, changes in Ki-67 expression, and the incidence of immune-related and other adverse events. Exploratory analyses will assess changes in the tumor immune microenvironment, including immune-cell infiltration and the expression of PD-1, programmed death-ligand 1, and CTLA-4, using blood and tumor specimens collected at protocol-specified time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned in a 1:1 ratio to two parallel treatment arms. The experimental arm will receive an aromatase inhibitor plus a CDK4/6 inhibitor and QL1706, whereas the active comparator arm will receive an aromatase inhibitor plus a CDK4/6 inhibitor.
| Arm | Type | Receives |
|---|---|---|
| QL1706 Plus Endocrine Therapy | Experimental | Drug: Iparomlimab and Tuvonralimab (QL1706), Drug: Aromatase Inhibitor (AI), Drug: CDK4/6 inhibitor, Drug: Ovarian function suppressionParticipants will receive an aromatase inhibitor plus a CDK4/6 inhibitor and QL1706. QL1706 will be administered intravenously at 5 mg/kg on Day 1 of each 3-week cycle for six cycles. The aromatase inhibitor and CDK4/6 inhibitor will be administered according to their respective prescribing information or applicable clinical guidelines throughout the neoadjuvant treatment period. Premenopausal and perimenopausal participants will also receive ovarian function suppression. |
| Endocrine Therapy | Active comparator | Drug: Aromatase Inhibitor (AI), Drug: CDK4/6 inhibitor, Drug: Ovarian function suppressionParticipants will receive an aromatase inhibitor plus a CDK4/6 inhibitor according to the respective prescribing information or applicable clinical guidelines throughout the neoadjuvant treatment period. Premenopausal and perimenopausal participants will also receive ovarian function suppression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female participants aged 18 to 75 years.
- Histologically or pathologically confirmed HR-positive/HER2-negative early or locally advanced breast cancer, classified as stage IIB-IIIC, with a poor response to two cycles of neoadjuvant TAC chemotherapy. Chemotherapy sensitivity is defined as a reduction in tumor size of at least 40% on magnetic resonance imaging (MRI), whereas a poor response is defined as a reduction in tumor size of less than 40%.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- No prior antitumor treatment other than the two cycles of neoadjuvant TAC chemotherapy specified in this study, including no prior immune checkpoint inhibitor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (7 listed)
- Known hypersensitivity to any study drug or any of its excipients.
- Inflammatory breast cancer, bilateral breast cancer, or advanced breast cancer with distant metastases.
- A history of another malignancy within the past 5 years, except for malignancies treated with curative intent.
- Serious concomitant diseases, including extensive interstitial pneumonitis requiring pharmacological treatment; active or uncontrolled infection, including tuberculosis or human immunodeficiency virus infection; decompensated liver disease; active hepatitis; active bleeding; a history of cerebrovascular events or pulmonary embolism; active, known, or suspected autoimmune disease; or an active infection currently requiring systemic anti-infective therapy.
- Active brain metastases or leptomeningeal metastases, unless the metastases have been treated and are stable.
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706)Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at 5 mg/kg on Day 1 of each 3-week cycle for six cycles. | Drug | QL1706 Plus Endocrine Therapy |
| Aromatase Inhibitor (AI)Also: Exemestane, Anastrozole, LetrozoleParticipants will receive exemestane, anastrozole, or letrozole. The specific aromatase inhibitor, dose, and administration schedule will be selected according to the applicable prescribing information or clinical guidelines and will be continued throughout the approximately 18-week neoadjuvant treatment period. | Drug | Endocrine Therapy, QL1706 Plus Endocrine Therapy |
| CDK4/6 inhibitorAlso: Abemaciclib, RibociclibParticipants will receive abemaciclib or ribociclib. The specific CDK4/6 inhibitor, dose, and administration schedule will be selected according to the applicable prescribing information or clinical guidelines and will be continued throughout the approximately 18-week neoadjuvant treatment period. | Drug | Endocrine Therapy, QL1706 Plus Endocrine Therapy |
| Ovarian function suppressionAlso: Goserelin, Leuprorelin, TriptorelinPremenopausal and perimenopausal participants will receive ovarian function suppression with goserelin, leuprorelin, or triptorelin. The specific agent, dose, and administration schedule will follow the applicable prescribing information or clinical guidelines. | Drug | Endocrine Therapy, QL1706 Plus Endocrine Therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: From randomization through the preoperative assessment after six treatment cycles, approximately 18 weeks
The proportion of participants whose best overall response is complete response (CR) or partial response (PR), as assessed by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR will be calculated as the number of participants achieving CR or PR divided by the total number of participants included in the efficacy analysis, multiplied by 100%.
6 secondary outcomes
Breast Pathological Complete Response Rate (bpCR)
Time frame: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Total Pathological Complete Response Rate (tpCR)
Time frame: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Miller-Payne Grade
Time frame: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Residual Cancer Burden (RCB) Class
Time frame: At surgery after completion of six treatment cycles, approximately 18 weeks after randomization
Incidence of Immune-Related Adverse Events
Time frame: From the first dose of study treatment through 30 days after the last dose, approximately 22 weeks
Change From Baseline in Ki-67 Expression
Time frame: From baseline to surgery after completion of six treatment cycles, approximately 18 weeks
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 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the data contain confidential clinical and biomarker information and are subject to participant privacy, informed consent, and ethics requirements. Aggregated study results will be reported through the ClinicalTrials.gov registry and scientific publications.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI) and CDK4/6 inhibitor in people with Breast Cancer, run by Hebei Medical University Fourth Hospital.
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 7 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Li Ma, MD (+86 86296348, 47500562@hebmu.edu.cn), 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: From randomization through the preoperative assessment after six treatment cycles, approximately 18 weeks). 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 26 Aug 2026.