Breast CancerPhase 2NCT05165225

Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

A Phase 2 study testing Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment in people with Breast Cancer and HER2-low-expressing 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 single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR positive and HER2-low-expressing early or locally advanced breast cancer. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer
What is being tested?: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 13 Jul 2021to 31 Mar 2028
Phase: Phase 2

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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures
Female patients, age ≥ 18 years
Histologically confirmed unilateral primary carcinoma of the breast, except for occult breast cancer, inflammatory breast cancer without assessable focus or eczema like breast cancer
HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/or PR >1% stained cells)
Tumour greater than 2 cm diameter or histologically (core- or fine-needle biopsy) involved lymph nodes
According to RECIST version 1.1, there is at least one evaluable target lesion

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Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
Required laboratory values including following parameters: WBC count:≥3.0 x 10^9/L ; ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 100 x 10^9/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine: ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 55%
For female patients without menopause or surgical sterilization: consent to contraception both during the trial and within 6 months after the last administration of the test drug

Who cannot join

Metastatic disease (Stage IV) or bilateral breast cancer
Known history of hypersensitivity to pyrotinib or any of it components
According to the judgment of the researcher, other anti-tumor treatments (except for ovarian function inhibitors) are required during neoadjuvant therapy
Patients with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to these: 1). Fatal arrhythmia or higher grade atrioventricular block (second degree type 2 atrioventricular block or third degree atrioventricular block) 2). Unstable angina pectoris 3). Heart valve disease with clinical significance 4). ECG showed transmural myocardial infarction pain 5). Poor control of hypertension
Patients underwent major breast cancer-free surgery within 4 weeks or have not fully recovered
Serious or uncontrolled infections that may affect study treatment or evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc

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History of other malignant tumors in the past 5 years (excluding cured carcinoma in situ of cervix or skin basal cell carcinoma)
Those with basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation)；Inability to swallow、intestinal obstruction or other factors will affect drug administration and absorption
The investigator believes that the patient has any other conditions that are not suitable for participation in 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

Conditions: Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
Being tested: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
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 and cyclophosphamide followed by docetaxel treatmentDrug
Drug: Pyrotinib pyrotinib 320mg orally daily Drug: Epirubicin epirubicin 90mg/m^2 d1 iv Q3W for 4 cycles Drug: Cyclophosphamide cyclophosphamide 600mg/m^2 d1 iv Q3W for 4 cycles Drug: Docetaxel docetaxel 100mg/m^2 d1 iv Q3W for 4 cycles

Study groups in NCT05165225
Study group	Role	What they receive
Pyrotinib	Experimental	Experimental: Patients will receive Pyrotinib combined with Epirubicin and Cyclophosphamide followed by Docetaxel Receives: Drug: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

What is being measured

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

Residual cancer burden 0/1 (RCB-0/1) rate
The percentage of patients with RCB-0/1 after neoadjuvant therapy
Measured: within 6 weeks after surgery

Secondary outcomes (7)

Pathological complete response (pCR) rate
The percentage of patients with pCR (ypT0/is, ypN0) after neoadjuvant therapy
Measured: within 6 weeks after surgery
Objective response rate (ORR)
The percentage of subjects with CR or PR as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of preoperative neoadjuvant therapy 【(CR+PR)/Analysis of the total number of people】
Measured: within 6 weeks after surgery
Breast conservation rate.
The breast conservation rate after treatment.
Measured: within 6 weeks after surgery
Disease-free Survival (DFS)
The DFS is defined as the time from registration until any relapse, secondary malignancy, or death from any cause
Measured: 5 years
Overall Survival (OS).
The OS is defined as the time from registration to death, irrespective of cause.
Measured: 5 years
Biomarkers
Biomarkers: e.g. Tils
Measured: 5 years
Incidence of grade 3-5 diarrhea.
Diarrhea were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Measured: before surgery

Timeline

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

13 Jul 202131 Mar 2028

First posted21 Dec 2021
Study start13 Jul 2021
Primary completion30 Sep 2023
Study completion31 Mar 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05165225
Sponsor's protocol ID: PILHLE-001
Status last verified: Sep 2026
First submitted: 20 Dec 2021
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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