Breast CancerPhase 2NCT07410559
Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer
A Phase 2 study testing Imlunestrant + abemaciclib and (dd)EC*4-T*4 in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer. 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?
- Imlunestrant + abemaciclib and (dd)EC*4-T*4
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 2031
- 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 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Primary breast tumor diameter > 1 cm.
- Histologically confirmed invasive ER+/HER2- breast cancer, meeting ER≥50% and Ki67≥10%. HER2 negativity is defined as HER2 immunohistochemistry (IHC) 0-1+, or IHC 2+ with fluorescence in situ hybridization (FISH) confirming no amplification.
- Clinical tumor stage: cT1c-T4, cN0-cN2, cM0.
- Willing to undergo breast cancer surgery once surgical criteria are met after neoadjuvant therapy.
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- Adequate organ function, meeting all of the following:
- Hemoglobin (Hb)≥90 g/L and patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion;
- Absolute neutrophil count (ANC)≥1.5×10^9/L;
- Platelet count (PLT)≥100×10^9/L;
- Total bilirubin (TBIL)≤1.5×the upper limit of normal (ULN) and patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN;
- Alkaline phosphatase (ALP)≤2.5×ULN;
- Serum creatinine (Cr)≤1.5×ULN;
- Prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN, and international normalized ratio (INR)≤1.5×ULN (in patients not receiving anticoagulation).
- Left ventricular ejection fraction (LVEF)≥55% at baseline as measured by echocardiography or multi-gated acquisition (MUGA) scan.
- Women with premenopausal status should receive ovarian suppression with a gonadotropin-releasing hormone agonist such as goserelin or leuprolide before initiation of treatment to become postmenopausal status. Postmenopausal due to surgical/natural menopause requires at least 1 of the following:
- prior bilateral oophorectomy;
- age≥60 years;
- age<60 years, amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression), and FSH and estradiol levels in the postmenopausal range.
- Women of childbearing potential must have a negative serum pregnancy test. Such patients must use a medically acceptable method of contraception during study treatment and for at least 6 months after the last dose of the study drug(s).
- The subject voluntarily agrees to participate, signs the informed consent form, has good compliance, and is willing to adhere to follow-up.
Who cannot join
- Stage IV (metastatic) breast cancer or bilateral breast cancer.
- Prior history of invasive breast cancer.
- Prior history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
- Any prior chemotherapy, endocrine therapy, or anti-HER2 therapy for breast cancer; or prior excisional biopsy of the primary breast tumor and/or axillary lymph nodes, or prior local radiotherapy (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors).
- Any other malignancy within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer.
- Peripheral neuropathy≥Grade 2 per NCI-CTCAE v6.0.
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- Serious cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to congestive heart failure, unstable angina, severe arrhythmias uncontrolled by medication, severe conduction abnormalities or clinically significant valvular disease, uncontrolled severe hypertension, myocardial infarction, or cerebrovascular accident.
- Any serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Major surgery within 4 weeks prior to randomization without full recovery, or an anticipated need for major surgery during study treatment.
- Known active liver disease, including but not limited to active hepatitis B (defined as HBsAg positive with HBV-DNA≥1000 IU/mL), hepatitis C (defined as HCV-Ab positive with HCV-RNA above the assay's lower limit of quantification), or autoimmune liver disease.
- Severe and uncontrolled infection or known HIV infection.
- Active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment) or fungal infection.
- Pregnant or breastfeeding.
- Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Known abuse of psychotropic substances, alcoholism, or drug abuse.
- Known, definite neurological or psychiatric disorders associated with poor compliance, including but not limited to epilepsy or dementia.
- Any other serious physical or mental illness or laboratory abnormality that may increase the risk of study participation or interfere with study treatment and outcomes, or any other condition that, in the investigator's judgment, makes the patient unsuitable for this study.
- The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Keda Yu, Professor, +86-021-64175590, yukeda@fudan.edu.cn
About this study
Official title: Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer: A Randomized Phase 2 Trial (IMPATIENS)
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.
Read the detailed description
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer. Eligible subjects who provide informed consent will first receive a 2-week window-of-opportunity treatment with imlunestrant combined with abemaciclib, followed by a biopsy of the primary lesion to assess Ki67 at 2 weeks. If the Ki67 of the primary lesion after 2 weeks is <7.4%, they will be randomized in a 1:1 ratio to either Imlunestrant plus abemaciclib or neoadjuvant chemotherapy. If the Ki67 of the primary lesion after 2 weeks is ≥7.4%, patients will be assigned to neoadjuvant chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Imlunestrant + abemaciclib, (dd)EC*4-T*4
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imlunestrant + abemaciclibDrug
Imlunestrant (400 mg orally, once daily) combined with abemaciclib (150 mg orally, twice daily) for 24 weeks.
(dd)EC*4-T*4Drug
Epirubicin (90 mg/m², intravenous infusion) combined with cyclophosphamide (600 mg/m², intravenous infusion, every 2 weeks or 3 weeks, determined by investigators) for 4 cycles, followed by docetaxel (100 mg/m², intravenous infusion, every 3 weeks) for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Imlunestrant + abemaciclib) | Experimental | If the Ki67 of the primary lesion after 2 weeks is <7.4% Receives: Drug: Imlunestrant + abemaciclib |
| Arm B [(dd)EC*4-T*4] | Active comparator | If the Ki67 of the primary lesion after 2 weeks is <7.4% Receives: Drug: (dd)EC*4-T*4 |
| Arm C [(dd)EC*4-T*4] | Active comparator | If the Ki67 of the primary lesion after 2 weeks is ≥7.4% Receives: Drug: (dd)EC*4-T*4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR between Arm A and Arm B
Defined as the proportion of patients whose tumor shrinks by a certain amount and maintains that reduction for a certain time, including cases of complete response (CR) and partial response (PR). Tumor objective response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). Subjects must have measurable tumor lesions at baseline.
Measured: Immediately after the surgery
pCR rate between Arm A and Arm B
Defined as achieving pCR (ypT0/is, ypN0) upon postoperative pathological assessment, meaning the absence of any residual invasive cancer in the pathological evaluation of hematoxylin and eosin-stained resected breast samples and all ipsilateral lymph node samples after completing neoadjuvant therapy and surgery.
Measured: Immediately after the surgery
Secondary outcomes (4)
Relative changes of Ki67 index between Arm A and Arm B
Defined as the geometric mean percentage change in Ki67 index from baseline to post-surgery. For patients with no detectable invasive cancer in the primary site post-surgery, a Ki67 value of 0.01 will be used as a substitute.
Measured: Immediately after the surgery
3-year EFS between Arm A and Arm B
Defined as the time from randomization to the first recorded relevant event. Relevant events include preoperative disease progression, postoperative disease recurrence or metastasis, contralateral invasive breast cancer, second primary invasive cancer, and death from any cause.
Measured: Following surgery until Year 3
3-year OS between Arm A and Arm B
Defined as the time from randomization to death from any cause. For subjects still alive at the last follow-up, OS is censored at the last follow-up time.
Measured: Following surgery until Year 3
Adverse events assessed according to CTCAE v6.0 criteria
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V6.0)
Measured: Up to one year during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Jul 2031 (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.
- More trials run by Fudan 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
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keda Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410559
- Sponsor's protocol ID
- IMPATIENS
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer: A Randomized Phase 2 Trial (IMPATIENS)
- ClinicalTrials.gov ID
- NCT07410559
- Acronym / sponsor ID
- IMPATIENS
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 13 Feb 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 is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.
Detailed description
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer. Eligible subjects who provide informed consent will first receive a 2-week window-of-opportunity treatment with imlunestrant combined with abemaciclib, followed by a biopsy of the primary lesion to assess Ki67 at 2 weeks. If the Ki67 of the primary lesion after 2 weeks is <7.4%, they will be randomized in a 1:1 ratio to either Imlunestrant plus abemaciclib or neoadjuvant chemotherapy. If the Ki67 of the primary lesion after 2 weeks is ≥7.4%, patients will be assigned to neoadjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Imlunestrant + abemaciclib) | Experimental | Drug: Imlunestrant + abemaciclibIf the Ki67 of the primary lesion after 2 weeks is <7.4% |
| Arm B [(dd)EC*4-T*4] | Active comparator | Drug: (dd)EC*4-T*4If the Ki67 of the primary lesion after 2 weeks is <7.4% |
| Arm C [(dd)EC*4-T*4] | Active comparator | Drug: (dd)EC*4-T*4If the Ki67 of the primary lesion after 2 weeks is ≥7.4% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female patients aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Primary breast tumor diameter > 1 cm.
- Histologically confirmed invasive ER+/HER2- breast cancer, meeting ER≥50% and Ki67≥10%. HER2 negativity is defined as HER2 immunohistochemistry (IHC) 0-1+, or IHC 2+ with fluorescence in situ hybridization (FISH) confirming no amplification.
- Clinical tumor stage: cT1c-T4, cN0-cN2, cM0.
Key exclusion criteria (18 listed)
- Stage IV (metastatic) breast cancer or bilateral breast cancer.
- Prior history of invasive breast cancer.
- Prior history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
- Any prior chemotherapy, endocrine therapy, or anti-HER2 therapy for breast cancer; or prior excisional biopsy of the primary breast tumor and/or axillary lymph nodes, or prior local radiotherapy (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors).
- Any other malignancy within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer.
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 |
|---|---|---|
| Imlunestrant + abemaciclibImlunestrant (400 mg orally, once daily) combined with abemaciclib (150 mg orally, twice daily) for 24 weeks. | Drug | Arm A (Imlunestrant + abemaciclib) |
| (dd)EC*4-T*4Epirubicin (90 mg/m², intravenous infusion) combined with cyclophosphamide (600 mg/m², intravenous infusion, every 2 weeks or 3 weeks, determined by investigators) for 4 cycles, followed by docetaxel (100 mg/m², intravenous infusion, every 3 weeks) for 4 cycles. | Drug | Arm B [(dd)EC*4-T*4], Arm C [(dd)EC*4-T*4] |
Primary outcome
ORR between Arm A and Arm B
Time frame: Immediately after the surgery
Defined as the proportion of patients whose tumor shrinks by a certain amount and maintains that reduction for a certain time, including cases of complete response (CR) and partial response (PR). Tumor objective response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). Subjects must have measurable tumor lesions at baseline.
pCR rate between Arm A and Arm B
Time frame: Immediately after the surgery
Defined as achieving pCR (ypT0/is, ypN0) upon postoperative pathological assessment, meaning the absence of any residual invasive cancer in the pathological evaluation of hematoxylin and eosin-stained resected breast samples and all ipsilateral lymph node samples after completing neoadjuvant therapy and surgery.
4 secondary outcomes
Relative changes of Ki67 index between Arm A and Arm B
Time frame: Immediately after the surgery
3-year EFS between Arm A and Arm B
Time frame: Following surgery until Year 3
3-year OS between Arm A and Arm B
Time frame: Following surgery until Year 3
Adverse events assessed according to CTCAE v6.0 criteria
Time frame: Up to one year during follow-up
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 18 Feb 2026.
- 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 2 study testing Imlunestrant + abemaciclib and (dd)EC*4-T*4 in people with Breast Cancer, run by Fudan 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 22 inclusion and 18 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 18 Feb 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?
ORR between Arm A and Arm B (time frame: Immediately after the surgery). 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 18 Feb 2026.