Breast Cancer InvasivePhase 3NCT06144944

Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

A Phase 3 study testing Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel and Epirubicin or doxorubicin, cyclophosphamide, paclitaxel in people with Breast Cancer Invasive and Hormone-receptor-positive Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer Read more about this study

Who is it for?: Ages 17 to 70 years
Conditions the study is for: Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma
What is being tested?: Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel and Epirubicin or doxorubicin, cyclophosphamide, paclitaxel
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: 160 participants
Where: 1 siteChina
Study dates: 17 Jan 2024to 31 Dec 2031
Phase: Phase 3

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 17 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Must participate voluntarily, sign the informed consent form, and have good compliance
Aged ≥ 18 and ≤ 70 years old with ECOG PS score of 0-1
Histopathological newly diagnosed, unilateral, primary invasive breast cancer
Histopathological hormone receptor-positve ( estrogen receptor and/or progesterone receptor ≥ 10% stained cells) and HER2-low (immunochemistry 2+ with fluorescent in situ hybridization negative)
TNM stage-IIb/III, or TNM stage-IIa with high risk (N+, G3, or MammaPrint High-risk)
At least one evaluable target breast lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

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Left ventricular ejection fraction ≥ 55%, Fridericia-corrected QT interval < 450 ms in males and < 470 ms in females
White blood cell count: ≥ 3.0 × 10^9/L, absolute neutrophil count: ≥ 1.5 × 10^9/L, platelet count: ≥ 100 × 10^9/L, hemoglobin: ≥ 90 g/L
Aspartate aminotransferase and alanine aminotransferase: ≤ 2.5 × ULN, alkaline phosphatase: ≤ 2.5 × ULN, blood total bilirubin: ≤ 1.5 × ULN, serum creatinine: ≤ 1.5 × ULN
Non-menopausal or non-surgically sterilized female patients identified as non-pregnant and non-lactating and consented to contraception both during the trial and within 6 months after the last administration of the test drug

Who cannot join

Metastatic BC, bilateral BC, occult BC, inflammatory BC, or with other malignant tumors
Known history of hypersensitivity to the study drugs
Patients who need receive other anti-tumor treatments (except for OFS) during neoadjuvant therapy as judged by the investigators
With severe cardiac disease or discomfort that is not expected to tolerate treatment, including but not limited to: a) arrhythmia that requires medication or is clinically significant, or high-grade atrioventricular block, b) unstable angina, myocardial infarction, heart failure or clinically significant heart valve disease, c) poorly controlled hypertension or any heart disease unsuitable for participation in this trial as determined by the investigators
Patients who participated in a clinical trial of another drug within 4 weeks prior to randomization or underwent BC-free surgery within 4 weeks or had not fully recovered after BC-free surgery
Other malignancy in the past 5 years, other than cured cervical carcinoma in situ, basal or squamous cell carcinoma of skin

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Patients who had basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation), inability to swallow, intestinal obstruction or other factors will affect drugs administration and absorption
Presence of accompanying diseases that may pose serious risks to the safety of the patient or may affect the patient's ability to complete the study (including but not limited to severe diabetes mellitus, active infection, thyroid disorders, etc.) as judged by the investigator
With a history of immunodeficiency, including acquired or congenital immunodeficiencies, or a history of organ transplantation
Past history of confirmed neurological or mental disorders, including epilepsy or dementia
Other conditions of the subject determined by the investigator to be unsuitable for the study

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: Neoadjuvant Pyrotinib Combined With Chemotherapy Versus Chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) High-risk Early Breast Cancer: an Open-lable, Multi-center, Randomized Phase III Trial

Conditions: Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer
Being tested: Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel, Epirubicin or doxorubicin, cyclophosphamide, paclitaxel
Keywords: pyrotintb, HER2-low EBC, neoadjuvant, HR-positive
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxelDrug
Pyrotinib 320 mg orally once daily, and epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.
Epirubicin or doxorubicin, cyclophosphamide, paclitaxelDrug
Epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

Study groups in NCT06144944
Study group	Role	What they receive
Neoadjuvant pyrotinib combined with chemotherapy	Experimental	Not described Receives: Drug: Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel
Neoadjuvant chemotherapy	Placebo comparator	Not described Receives: Drug: Epirubicin or doxorubicin, cyclophosphamide, paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Residual Cancer Burden 0/1 rate as assessed by independent central review
The proportion of patients with RCB 0/I after neoadjuvant therapy according to the online Residual Cancer Burden Calculator provided by the MD Anderson Cancer Center as assessed by independent central review
Measured: Within 4 weeks after surgery

Secondary outcomes (10)

Residual Cancer Burden 0/1 rate as assessed by local pathology review
The proportion of patients with RCB 0/I after neoadjuvant therapy according to the online Residual Cancer Burden Calculator provided by the MD Anderson Cancer Center as assessed by local pathology review
Measured: Within 4 weeks after surgery
Pathological complete response rate
The proportion of patients with no residual invasive tumor cells in the breast and axillary nodes, regardless of ductal carcinoma in situ
Measured: Within 4 weeks after surgery
Objective response rate
The percentage of patients who achieved a complete or partial response in breast according to the RECIST, version 1.1, based on MRI, at the end of cycle 2 neoadjuvant therapy and at the end of cycle 8 neoadjuvant therapy
Measured: Within 2 weeks of breast MR examination
Breast conservation surgery rate
The proportion of patients who had successful breast conservation surgery after neoadjuvant therapy
Measured: Within 4 weeks after surgery
Health-related Quality of Life 1
The score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (version 3)
Measured: Within 7 days before the first treatment and the end of each cycle (each cycle is 21 days)
Health-related Quality of Life 2
The score of Breast Cancer-Specific Module (QLQ-BR23)
Measured: Within 7 days before the first treatment and the end of each cycle (each cycle is 21 days)
5-year event-free survival
the time from random assignment until any relapse, unequivocal tumor progression, or any-cause death
Measured: During the 5 years after random assignment
5-year overall survival
the time from random assignment until any-cause death
Measured: During the 5 years after random assignment
Safety (AEs+SAEs)
General safety will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). Ovarian toxicity will be evaluated by menstrual status and FSH and E2
Measured: from signing the informed consent form until 2 years after completion of neoadjuvant treatment
Biomarkers (Immune cell subpopulations quantities)
The association between immune cell subpopulations quantities and RCB
Measured: Within 4 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 202431 Dec 2031

First posted22 Nov 2023
Study start17 Jan 2024
Primary completion18 Jul 2026
Study completion31 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast Cancer InvasiveStudies 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: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06144944
Sponsor's protocol ID: PILHLE-002
Status last verified: Aug 2026
First submitted: 14 Nov 2023
Last updated: 18 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in future research article after de-identification and the study protocol will be shared beginning 3 months and ending 5 years following publication. Proposals should be directed to gchang@mail.sysu.edu.cn and data will be shared by email

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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