Breast CancerPhase 3NCT06313983
A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
A Phase 3 study testing Hemay022+AI and Lapatinib+Capecitabine in people with Breast Cancer, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hemay022+AI and Lapatinib+Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2022to Jun 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old；
- Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;
- Breast cancer subjects diagnosed by pathology（histology or cytology）;
- ER positive and HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive)；Previous test results are acceptable.
- Advanced/metastatic breast cancer that has previously received treatment failure with trastuzumab (or trastuzumab biosimilar) regimen;Or (new) adjuvant therapy during treatment with trastuzumab (or trastuzumab biosimilar) or within 12 months after the end of treatment, disease recurrence or progression；Patients with first-line systemic treatment for relapse (previously received trastuzumab or trastuzumab biosimilars)；Or patients who are not suitable for trastuzumab treatment；Patients who have failed previous anti-HER2-ADC drug therapy can also be included.
- At least one lesion (measurable and/or non-measurable) that can be evaluated by CT/MRI and meets the reproducible evaluation requirements of RECIST V1.1;
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- ECOG Performance Status of 0-1;
- The estimated survival time is more than 3 months;
- Postmenopausal women
- Postmenopausal is defined as meeting any one of the following four conditions:
- Past bilateral oophorectomy; Age ≥60 years old; Age <60 years old, natural menopause ≥12 months, in the past 1 year without chemotherapy, tamoxifen, toremifene or ovarian castration, the level of follicle stimulating hormone (FSH) and estradiol Within the postmenopausal range (use the reference range of the local laboratory).
- Patients younger than 60 years old who are taking tamoxifen or toremifene, their FSH and estradiol levels are within the postmenopausal range (use the reference range of the local laboratory); Premenopausal or perimenopausal women who do not meet the above-mentioned menopausal criteria can also be included in this study, but they must also receive ovarian suppression therapy that meets the standards of medical or surgical castration treatment. Drug ovarian suppression therapy has been started at least 21 days before the start of this program, and Must be continued during the treatment plan;
- Adequate bone marrow, liver, kidney, and coagulation Bone Marrow Function (No blood transfusion or adjuvant leukocyte or platelet augmentation drugs were used within 1 week before screening) Absolute value of neutrophils (ANC) ≥1.5×109/L Hemoglobin (HB) ≥90g/L (transfusion allowed) Platelet (PLT) ≥80×109/L Liver function Liver function grade Child-Pugh A/B (≤9 points) Alanine transferase (ALT) or aspartate aminotransferase (AST) ≤2.5 ULN in the absence of liver metastasis; ALT or AST≤ 5x ULN with liver metastasis Renal function: serum creatinine ≤1.5 times ULN;
- All previous treatment-related toxicities must be CTCAE (version 5.0) ≤ Grade 2 at the time of randomization, except for hair loss, pigmentation, and long-term toxicity caused by radiotherapy (which cannot be recovered by the investigator's judgment)；
- Women patients of childbearing age (including their partners) have no pregnancy plan and voluntarily take effective contraceptive measures from the signing of the informed consent form to 3 months after the last medication.
Who cannot join
- Patients with visceral crisis（Visceral crisis is defined as the dysfunction of several organs confirmed by symptoms, signs, laboratory tests, and rapid disease progression.Visceral crisis does not simply refer to the presence of visceral metastases, but to critical visceral conditions that require rapid and effective treatment to control the disease progression, especially when the opportunity for chemotherapy is lost after progression）
- Patients with the presence of spinal cord compression or brain, meningeal metastases
- Patients who have been treated with a small molecule HER2 tyrosine kinase inhibitor (HER2-TKI) (medication course ≤2 weeks is excluded)
- Have received radiotherapy within 4 weeks prior to study；
- Have received chemotherapy for advanced breast cancer> 1 lines (the subjects who have used chemotherapy drugs must have stopped the chemotherapy drugs for ≥ 4 weeks before being enrolled in this study);
- Patients with parenteral nutrition; malabsorption syndrome; or any condition possibly affecting drug absorption or inability to tolerate oral medications;
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- Use of any drug that inhibits or induces hepatic metabolism of Hemay022 within 2 weeks prior to study and entire study duration, for example CYP3A4 strong inhibitors or strong inducers;
- Patients who are known to have a history of allergies to Hemay022, lapatinib、AI (letrozole, exemestane) capecitabine or similar drugs.
- Left ventricular ejection fraction (LVEF) <50％ as measured by echocardiogram or MUGA scan.
- Positive blood for human immunodeficiency virus (HIV antibody); Positive hepatitis B surface antigen and HBV-DNA>upper limit of normal; Active hepatitis C virus (HCV) infection
- Patients with active infection requiring intravenous anti-infective treatment
- Arrhythmias requiring treatment , including atrial fibrillation, supraventricular tachycardia ,ventricular tachycardia, ventricular fibrillation, or patients with coronary heart disease have symptoms requiring medicine treatment, myocardial infarction within 1 year, congestive heart failure (CHF)
- Confirmed QTc prolongation (≥500ms) (heart rate corrected according to Bazett formula or Fridericia formula)
- People with a history of interstitial lung disease that needs treatment, a history of radiation pneumonitis, or clinically active interstitial lung disease
- Have received other clinical trial drugs within 4 weeks before the study
- Major surgery or injury less than 4 weeks before the study
- The study period must be accompanied by other antitumor therapy，such as chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except symptomatic local radiotherapy)
- Any other malignant cancer within 5 years with the exception of adequately treated cervical cancer in situ or basal and squamous cutaneous cell carcinomas
- Any condition that would make the subject inappropriate for this study by the investigator's judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ⅲ Randomized, Open Label, Parallel, Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2+/ER+ Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens
The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.
The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc.
- Conditions
- Breast Cancer
- Being tested
- Hemay022+AI, Lapatinib+Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay022+AIDrug
hemay022：orally once daily，A 21-day cycle
Lapatinib+CapecitabineDrug
Take the pills according to the instructions
| Study group | Role | What they receive |
|---|---|---|
| Hemay022 and AI | Experimental | Hemay022 in combination with AI will be taken orally once daily. Planned dose of Hemay022 will be 500mg daily for 21 days. Receives: Drug: Hemay022+AI |
| Lapatinib and Capecitabine | Active comparator | lapatinib in combination with capecitabine will be taken in suitable dose until disease progression or death, etc. Receives: Drug: Lapatinib+Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1
PFS defined as the proportion of patients alive and without progression
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (5)
Overall Survival (OS) of the two group according to RECIST v1.1
OS is defined as the time from random to any cause of death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1
ORR defined as the proportion of subjects in complete response (CR) or (partial response) PR
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Clinical benefit rate (CBR) according to RECIST v1.1
Clinical benefit rate defined as percentage of patients with stable disease (SD) ≥ 6 months/partial response (PR)/complete response (CR).
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response (DOR) according to RECIST v1.1
DOR defined as the duration after the first assessment as CR or PR, only applicable to subjects who have achieved remission
Measured: The earliest date from the first recorded CR or PR to the first recorded disease progression or death，assessed up to 100 months
Time to Response (TTR)
TTR defined as the time from random to CR or PR for the first time
Measured: Start of treatment until the earliest date of CR or PR recorded for the first time，assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313983
- Sponsor's protocol ID
- HM022BC3C01
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang P, Wang L, Zhen Y, Wang Z, Zhang H, Jones R, Xu B. A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer. Chin J Cancer Res. 2024 Feb 29;36(1):46-54. doi: 10.21147/j.issn.1000-9604.2024.01.05.
PubMed 38455366
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Randomized, Open Label, Parallel, Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2+/ER+ Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens
- ClinicalTrials.gov ID
- NCT06313983
- Acronym / sponsor ID
- HM022BC3C01
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Mar 2024 (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 purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.
The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemay022 and AI | Experimental | Drug: Hemay022+AIHemay022 in combination with AI will be taken orally once daily. Planned dose of Hemay022 will be 500mg daily for 21 days. |
| Lapatinib and Capecitabine | Active comparator | Drug: Lapatinib+Capecitabinelapatinib in combination with capecitabine will be taken in suitable dose until disease progression or death, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years old；
- Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;
- Breast cancer subjects diagnosed by pathology（histology or cytology）;
- ER positive and HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive)；Previous test results are acceptable.
- Advanced/metastatic breast cancer that has previously received treatment failure with trastuzumab (or trastuzumab biosimilar) regimen;Or (new) adjuvant therapy during treatment with trastuzumab (or trastuzumab biosimilar) or within 12 months after the end of treatment, disease recurrence or progression；Patients with first-line systemic treatment for relapse (previously received trastuzumab or trastuzumab biosimilars)；Or patients who are not suitable for trastuzumab treatment；Patients who have failed previous anti-HER2-ADC drug therapy can also be included.
Key exclusion criteria (19 listed)
- Patients with visceral crisis（Visceral crisis is defined as the dysfunction of several organs confirmed by symptoms, signs, laboratory tests, and rapid disease progression.Visceral crisis does not simply refer to the presence of visceral metastases, but to critical visceral conditions that require rapid and effective treatment to control the disease progression, especially when the opportunity for chemotherapy is lost after progression）
- Patients with the presence of spinal cord compression or brain, meningeal metastases
- Patients who have been treated with a small molecule HER2 tyrosine kinase inhibitor (HER2-TKI) (medication course ≤2 weeks is excluded)
- Have received radiotherapy within 4 weeks prior to study；
- Have received chemotherapy for advanced breast cancer> 1 lines (the subjects who have used chemotherapy drugs must have stopped the chemotherapy drugs for ≥ 4 weeks before being enrolled in this study);
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 |
|---|---|---|
| Hemay022+AIhemay022：orally once daily，A 21-day cycle | Drug | Hemay022 and AI |
| Lapatinib+CapecitabineTake the pills according to the instructions | Drug | Lapatinib and Capecitabine |
Primary outcome
Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
PFS defined as the proportion of patients alive and without progression
5 secondary outcomes
Overall Survival (OS) of the two group according to RECIST v1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Clinical benefit rate (CBR) according to RECIST v1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response (DOR) according to RECIST v1.1
Time frame: The earliest date from the first recorded CR or PR to the first recorded disease progression or death，assessed up to 100 months
Time to Response (TTR)
Time frame: Start of treatment until the earliest date of CR or PR recorded for the first time，assessed up to 100 months
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 22 Apr 2025.
- Derived from this study: PubMed 38455366Zhang P, Wang L, Zhen Y, Wang Z, Zhang H, Jones R, Xu B. A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer. Chin J Cancer Res. 2024 Feb 29;36(1):46-54. doi: 10.21147/j.issn.1000-9604.2024.01.05.
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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 3 study testing Hemay022+AI and Lapatinib+Capecitabine in people with Breast Cancer, run by Tianjin Hemay Pharmaceutical Co., Ltd 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 15 inclusion and 19 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 22 Apr 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Huiping Li (13811012595, huipingli2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1 (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313983, which also lists 1 linked publication.
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 22 Apr 2025.