Breast CancerPhase 2NCT04872985
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
A Phase 2 study testing Pyrotinib, Epirubicin and Doxorubicin Hydrochloride Liposome Injection in people with Breast Cancer and Hormone-receptor Positive Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Hormone-receptor Positive Breast Cancer
- What is being tested?
- Pyrotinib, Epirubicin and Doxorubicin Hydrochloride Liposome Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 31 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting with histological(by core needle biopsy or by limited incisional biopsy) proven hormone receptor positive (ER≥10% and/or PR ≥1%), HER2 negative(IHC ≤2+ and/or FISH-) , stage II/ III breast cancer.
- Have clinical indication for neoadjuvant therapy.
- HER4 IHC score ≥ 4.
- Measurable disease (breast and/or lymph nodes).
- The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
- Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l.
Show all 12Show fewer
- Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL.
- Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min.
- Patients must have the ability to swallow oral medication.
- Without history of any kind of treatment to known malignancy (solid tumor or hematologic).
- Written informed consent.
- Accessible for treatment and follow-up.
Who cannot join
- Evidence of stage IV breast cancer.
- Contralateral invasive breast cancer or Inflammatory breast cancer.
- History of non-breast malignancies (except for in situ cervical cancers, basal cell carcinoma of the skin, squamous cell carcinomas of the skin or thyroid papillary carcinoma that had received curative treatment before enrollment) within 5 years prior to randomization.
- Known metastatic disease from any malignancy (solid tumor or hematologic).
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or QTcF ≥450 msec.
- Known hypersensitivity reaction to any of the components of the treatment.
- Pregnancy or lactation at the time of randomization.
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Efficacy and Safety of Pyrotinib in Combination With Neoadjuvant Chemotherapy in Stage II-III HR+/HER2-, HER4 High Expression Breast Cancer Patients: A Phase II, Single-center, Randomized, Double-Blinded, Placebo-Controlled Trial
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Patients randomized to the study arm/control arm will receive standard neoadjuvant chemotherapy in combination with pyrotinib/placebo, respectively. The primary endpoint of the study is the residual cancer burden 0/I (RCB 0/I) and total pathological complete response (tpCR) rate. Secondary endpoints include the breast pCR (bpCR) rate, objective response rate(ORR), event-free survival (EFS), overall survival (OS), rate of change in the Ki-67 proliferation index, correlations between potential biomarkers and treatment efficacy, and toxicity.
Read the detailed description
Pyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor HER1(EGFR), HER2 and HER4. Improvement of the chemotherapy efficacy and good tolerability have been shown by several stage II and III clinical trials in both the neoadjuvant and metastasis setting in HER2-positive breast cancers. Yet, the anti-tumor effect of Pyrotinib by targeting HER4 has not been determined. Preclinical studies show that HER4 is relatively highly expressed in hormone receptor positive and HER2-negative(HR+/HER2-) breast cancers. In MCF7 cell lines, Pyrotinib effectively repressed phosphorylation of MAPK and Akt signal transduction pathways to inhibit tumor cell proliferation. In HR+/HER2- tumor xenografts, Pyrotinib has been observed to inhibit tumor growth in a dose-dependent manner (unpublished data). Taken together, the data support the rationale that Pyrotinib may be efficacious in HER4 high expressed HR+/HER2- breast cancer and in combination with chemotherapy may lead to a better RCB 0/I and pCR rate in the neoadjuvant setting.
The study is a two-arm design with a 1:1 allocation ratio (equal numbers of patients randomized to Arms 1, 2). The sample size will be up to 140 patients with about 70 evaluable patients in each arm. Accrual is expected to occur over 48 months. Patients will be randomized to one of the two neoadjuvant therapy regimens: Patients in Arm 1 will be assigned to receive 400 mg Pyrotinib orally once per day with four cycles of epirubicin (100 mg/m2) (or doxorubicin hydrochloride liposome injection 30mg/m2) and cyclophosphamide (600 mg/m2) intravenously, once every 3 weeks, followed by four cycles of docetaxel (100 mg/m2) intravenously, once every 3 weeks(or nab-paclitaxel 260mg/m2 q3w, or 12 cycles of weekly nab-paclitaxel 120 mg/m2) . Dosage reduction of pyrotinib is permitted from 400 mg to 320 mg or 240 mg if Pyrotinib-related AEs are experienced. In Arm 2 (control), Pyrotinib will be replaced by 400mg placebo provided by the same pharmacy company.
In all arms, clinical response will be evaluated by breast MRI. The primary endpoint will be assessed with the paraffin embedded pathological specimens collected from surgery. Submission of tumor samples for the correlative science studies will be optional for all patients. For patients who agree, pathological sections of core biopsy specimen before treatment (after the patient has signed the consent form and has been screened for eligibility) and pathological sections of surgery residual disease specimen after the completion of the treatment are collected. In addition, a blood sample collected after randomization (before the start of study therapy and after the completion of the neoadjuvant therapy) will also be required for the correlative studies.
- Being tested
- Pyrotinib, Epirubicin, Doxorubicin Hydrochloride Liposome Injection, Cyclophosphamide, Docetaxel
- Keywords
- Pyrotinib, Pan-HER TKI, HER4
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
400 mg orally once per day. Pyrotinib starts with a dose of 240 mg once daily for one week, followed by 320 mg once daily for the next week, before transitioning to 400 mg once daily as maintenance therapy.
EpirubicinDrug
Also called E
100 mg/m2,q3W*4
Doxorubicin Hydrochloride Liposome InjectionDrug
Also called A
30mg/m2, q3w*4
CyclophosphamideDrug
Also called C
600 mg/m2, q3w*4
DocetaxelDrug
Also called T
100 mg/m2, q3w*4
Nab paclitaxelDrug
120mg/m2 qw*12 or 260mg/m2 q3w*4
PlaceboDrug
400 mg orally once per day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pyrotinib+ AC/EC followed by T | Experimental | 400 mg Pyrotinib orally once per day with four cycles of epirubicin (100 mg/m2) (or doxorubicin hydrochloride liposome injection 30mg/m2) and cyclophosphamide (600 mg/m2) intravenously, once every 3 weeks, followed by four cycles of docetaxel (100 mg/m2) intravenously, once every 3 weeks (or 260mg/m2 nab-paclitaxel once every 3 weeks for 4 cycles, or 12 cycles of weekly nab-paclitaxel 120mg/m2 intravenously). Pyrotinib starts with a dose of 240 mg once daily for one week, followed by 320 mg once daily for the next week, before transitioning to 400 mg once daily as maintenance therapy. Receives: Drug: Pyrotinib; Drug: Epirubicin; Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Nab paclitaxel |
| Arm 2: Placebo+ AC/EC followed by T | Placebo comparator | 400 mg placebo orally once per day with four cycles of epirubicin (100 mg/m2) (or doxorubicin hydrochloride liposome injection 30mg/m2) and cyclophosphamide (600 mg/m2) intravenously, once every 3 weeks, followed by four cycles of docetaxel (100 mg/m2) intravenously, once every 3 weeks (or 260mg/m2 nab-paclitaxel once every 3 weeks for 4 cycles, or 12 cycles of weekly nab-paclitaxel 120mg/m2 intravenously) . Receives: Drug: Epirubicin; Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Nab paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RCB 0/I (Residual cancer burden 0/I) rate
defined as the proportion of patients whose surgical specimens after neoadjuvant therapy were pathologically assessed as RCB 0 or RCB I.
Measured: At the time of surgery
tpCR (total pCR) rate
ypT0/isN0, number of participants with by no histologic evidence of invasive tumor cells in the surgical breast and axillary specimen.
Measured: At the time of surgery.
Secondary outcomes (9)
bpCR (breast pCR)
ypT0/is, number of participants with by no histologic evidence of invasive tumor cells in the surgical breast specimen.
Measured: At the time of surgery.
ORR (objective response) rate
the percentage of patients with a final overall response of CR or PR relative to the appropriate analysis set. Clinical response will be evaluated by breast MRI.
Measured: At the time of surgery.
EFS (event-free survival) at 3 and 5 years
EFS is defined as the time from randomization to the date of progression(according to RECIST 1.1 ) of disease that precludes surgery, local relapse, regional relapse, distant relapse, second primary invasive breast cancer including contralateral breast cancer, or death due to any cause which ever occurred first.
Measured: EFS will be determined at 3 and 5 years after randomization
OS (overall survival) at 3 and 5 years
OS is defined as the time from randomization to date of death.
Measured: OS will be determined at 3 and 5 years after randomization
Rate of change in the Ki-67 proliferation index
defined as change of Ki-67 expression in the tumor tissue before and after neoadjuvant therapy
Measured: Baseline and at the time of surgery
The correlation of potential biomarkers with the RCB 0/I, tpCR, bpCR and ORR rate.
We will used immunohistochemistry (IHC) method to assess the positive percentage of ER, PR, Ki67%, as well as the HER4 scores, and the status EGFR, HER3, and PD-L1 of the specimen from primary core biopsy at baseline. The IHC4 score will be calculated using our modified method (Jin et al. Oncologist. 2020 Aug;25(8):e1170-e1180.). The correlation between these biomarkers with treatment efficacy (RCB 0/I, tpCR, bpCR and ORR) will be explored.
Measured: The correlation with RCB 0/I, tpCR, bpCR and ORR will be assessed when the surgery is performed on the last enrolled patients.
The correlation of potential biomarkers with EFS and OS.
We will used immunohistochemistry (IHC) method to assess the positive percentage of ER, PR, Ki67%, as well as the HER4 scores, and the status EGFR, HER3, and PD-L1 of the specimen from primary core biopsy at baseline, as well as the residual surgical specimen after neoadjuvant chemotherapy. The IHC4 score will be calculated using our modified method (Jin et al. Oncologist. 2020 Aug;25(8):e1170-e1180.). The correlation between these biomarkers with EFS and OS will be analyzed
Measured: The correlation with EFS and OS will be performed at 5 years after the enrollment of the last patient.
AE (Adverse Event) and SAE (Serious Adverse Event) rate
Toxicities are graded according to NCI CTCAE v4.03.
Measured: Toxicity will be assessed from start treatment up to 30 days following the last dose of treatment.
The correlation between NGS sequencing and ctDNA data with clinical outcomes(Optional).
NGS sequencing will be performed with the pathological section of primary core biopsy and surgery residual specimen, and the ctDNA will be extracted from the patients' serum at baseline and the date of surgery, if with the agreement of participants. The correlation between these biomarkers with clinical outcomes (pCR and EFS) will be assessed when possible.
Measured: The correlation with pCR will be assessed when the surgery is performed on the last enrolled patients. The correlation with EFS and OS will be performed at 5 years after the enrollment of the last patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start20 Apr 2021
- Primary completion27 Feb 2026 (estimated)
- Study completion31 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.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Erwei Song, MD.,Phd., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872985
- Sponsor's protocol ID
- MA-BC-II-018
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2021
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pyrotinib in Combination With Neoadjuvant Chemotherapy in Stage II-III HR+/HER2-, HER4 High Expression Breast Cancer Patients: A Phase II, Single-center, Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04872985
- Acronym / sponsor ID
- MA-BC-II-018
- Keywords
- Pyrotinib, Pan-HER TKI, HER4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 May 2021 (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 Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Patients randomized to the study arm/control arm will receive standard neoadjuvant chemotherapy in combination with pyrotinib/placebo, respectively. The primary endpoint of the study is the residual cancer burden 0/I (RCB 0/I) and total pathological complete response (tpCR) rate. Secondary endpoints include the breast pCR (bpCR) rate, objective response rate(ORR), event-free survival (EFS), overall survival (OS), rate of change in the Ki-67 proliferation index, correlations between potential biomarkers and treatment efficacy, and toxicity.
Detailed description
Pyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor HER1(EGFR), HER2 and HER4. Improvement of the chemotherapy efficacy and good tolerability have been shown by several stage II and III clinical trials in both the neoadjuvant and metastasis setting in HER2-positive breast cancers. Yet, the anti-tumor effect of Pyrotinib by targeting HER4 has not been determined. Preclinical studies show that HER4 is relatively highly expressed in hormone receptor positive and HER2-negative(HR+/HER2-) breast cancers. In MCF7 cell lines, Pyrotinib effectively repressed phosphorylation of MAPK and Akt signal transduction pathways to inhibit tumor cell proliferation. In HR+/HER2- tumor xenografts, Pyrotinib has been observed to inhibit tumor growth in a dose-dependent manner (unpublished data). Taken together, the data support the rationale that Pyrotinib may be efficacious in HER4 high expressed HR+/HER2- breast cancer and in combination with chemotherapy may lead to a better RCB 0/I and pCR rate in the neoadjuvant setting.
The study is a two-arm design with a 1:1 allocation ratio (equal numbers of patients randomized to Arms 1, 2). The sample size will be up to 140 patients with about 70 evaluable patients in each arm. Accrual is expected to occur over 48 months. Patients will be randomized to one of the two neoadjuvant therapy regimens: Patients in Arm 1 will be assigned to receive 400 mg Pyrotinib orally once per day with four cycles of epirubicin (100 mg/m2) (or doxorubicin hydrochloride liposome injection 30mg/m2) and cyclophosphamide (600 mg/m2) intravenously, once every 3 weeks, followed by four cycles of docetaxel (100 mg/m2) intravenously, once every 3 weeks(or nab-paclitaxel 260mg/m2 q3w, or 12 cycles of weekly nab-paclitaxel 120 mg/m2) . Dosage reduction of pyrotinib is permitted from 400 mg to 320 mg or 240 mg if Pyrotinib-related AEs are experienced. In Arm 2 (control), Pyrotinib will be replaced by 400mg placebo provided by the same pharmacy company.
In all arms, clinical response will be evaluated by breast MRI. The primary endpoint will be assessed with the paraffin embedded pathological specimens collected from surgery. Submission of tumor samples for the correlative science studies will be optional for all patients. For patients who agree, pathological sections of core biopsy specimen before treatment (after the patient has signed the consent form and has been screened for eligibility) and pathological sections of surgery residual disease specimen after the completion of the treatment are collected. In addition, a blood sample collected after randomization (before the start of study therapy and after the completion of the neoadjuvant therapy) will also be required for the correlative studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pyrotinib+ AC/EC followed by T | Experimental | Drug: Pyrotinib, Drug: Epirubicin, Drug: Doxorubicin Hydrochloride Liposome Injection, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Nab paclitaxel400 mg Pyrotinib orally once per day with four cycles of epirubicin (100 mg/m2) (or doxorubicin hydrochloride liposome injection 30mg/m2) and cyclophosphamide (600 mg/m2) intravenously, once every 3 weeks, followed by four cycles of docetaxel (100 mg/m2) intravenously, once every 3 weeks (or 260mg/m2 nab-paclitaxel once every 3 weeks for 4 cycles, or 12 cycles of weekly nab-paclitaxel 120mg/m2 intravenously). Pyrotinib starts with a dose of 240 mg once daily for one week, followed by 320 mg once daily for the next week, before transitioning to 400 mg once daily as maintenance therapy. |
| Arm 2: Placebo+ AC/EC followed by T | Placebo comparator | Drug: Epirubicin, Drug: Doxorubicin Hydrochloride Liposome Injection, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Nab paclitaxel, Drug: Placebo400 mg placebo orally once per day with four cycles of epirubicin (100 mg/m2) (or doxorubicin hydrochloride liposome injection 30mg/m2) and cyclophosphamide (600 mg/m2) intravenously, once every 3 weeks, followed by four cycles of docetaxel (100 mg/m2) intravenously, once every 3 weeks (or 260mg/m2 nab-paclitaxel once every 3 weeks for 4 cycles, or 12 cycles of weekly nab-paclitaxel 120mg/m2 intravenously) . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Presenting with histological(by core needle biopsy or by limited incisional biopsy) proven hormone receptor positive (ER≥10% and/or PR ≥1%), HER2 negative(IHC ≤2+ and/or FISH-) , stage II/ III breast cancer.
- Have clinical indication for neoadjuvant therapy.
- HER4 IHC score ≥ 4.
- Measurable disease (breast and/or lymph nodes).
- The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
Key exclusion criteria (8 listed)
- Evidence of stage IV breast cancer.
- Contralateral invasive breast cancer or Inflammatory breast cancer.
- History of non-breast malignancies (except for in situ cervical cancers, basal cell carcinoma of the skin, squamous cell carcinomas of the skin or thyroid papillary carcinoma that had received curative treatment before enrollment) within 5 years prior to randomization.
- Known metastatic disease from any malignancy (solid tumor or hematologic).
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or QTcF ≥450 msec.
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 |
|---|---|---|
| Pyrotinib400 mg orally once per day. Pyrotinib starts with a dose of 240 mg once daily for one week, followed by 320 mg once daily for the next week, before transitioning to 400 mg once daily as maintenance therapy. | Drug | Arm 1: Pyrotinib+ AC/EC followed by T |
| EpirubicinAlso: E100 mg/m2,q3W*4 | Drug | Arm 1: Pyrotinib+ AC/EC followed by T, Arm 2: Placebo+ AC/EC followed by T |
| Doxorubicin Hydrochloride Liposome InjectionAlso: A30mg/m2, q3w*4 | Drug | Arm 1: Pyrotinib+ AC/EC followed by T, Arm 2: Placebo+ AC/EC followed by T |
| CyclophosphamideAlso: C600 mg/m2, q3w*4 | Drug | Arm 1: Pyrotinib+ AC/EC followed by T, Arm 2: Placebo+ AC/EC followed by T |
| DocetaxelAlso: T100 mg/m2, q3w*4 | Drug | Arm 1: Pyrotinib+ AC/EC followed by T, Arm 2: Placebo+ AC/EC followed by T |
| Nab paclitaxel120mg/m2 qw*12 or 260mg/m2 q3w*4 | Drug | Arm 1: Pyrotinib+ AC/EC followed by T, Arm 2: Placebo+ AC/EC followed by T |
| Placebo400 mg orally once per day | Drug | Arm 2: Placebo+ AC/EC followed by T |
Primary outcome
RCB 0/I (Residual cancer burden 0/I) rate
Time frame: At the time of surgery
defined as the proportion of patients whose surgical specimens after neoadjuvant therapy were pathologically assessed as RCB 0 or RCB I.
tpCR (total pCR) rate
Time frame: At the time of surgery.
ypT0/isN0, number of participants with by no histologic evidence of invasive tumor cells in the surgical breast and axillary specimen.
9 secondary outcomes
bpCR (breast pCR)
Time frame: At the time of surgery.
ORR (objective response) rate
Time frame: At the time of surgery.
EFS (event-free survival) at 3 and 5 years
Time frame: EFS will be determined at 3 and 5 years after randomization
OS (overall survival) at 3 and 5 years
Time frame: OS will be determined at 3 and 5 years after randomization
Rate of change in the Ki-67 proliferation index
Time frame: Baseline and at the time of surgery
The correlation of potential biomarkers with the RCB 0/I, tpCR, bpCR and ORR rate.
Time frame: The correlation with RCB 0/I, tpCR, bpCR and ORR will be assessed when the surgery is performed on the last enrolled patients.
The correlation of potential biomarkers with EFS and OS.
Time frame: The correlation with EFS and OS will be performed at 5 years after the enrollment of the last patient.
AE (Adverse Event) and SAE (Serious Adverse Event) rate
Time frame: Toxicity will be assessed from start treatment up to 30 days following the last dose of treatment.
The correlation between NGS sequencing and ctDNA data with clinical outcomes(Optional).
Time frame: The correlation with pCR will be assessed when the surgery is performed on the last enrolled patients. The correlation with EFS and OS will be performed at 5 years after the enrollment of the last patient.
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 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Erwei Song, MD.,Phd. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Pyrotinib, Epirubicin and Doxorubicin Hydrochloride Liposome Injection in people with Breast Cancer and Hormone-receptor Positive Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 12 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RCB 0/I (Residual cancer burden 0/I) rate (time frame: At the time of 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 6 Jan 2026.