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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
What is being tested?
Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
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
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 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

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.

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 groupRoleWhat they receive
PyrotinibExperimentalExperimental: 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.

  1. 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)

  1. Pathological complete response (pCR) rate

    The percentage of patients with pCR (ypT0/is, ypN0) after neoadjuvant therapy

    Measured: within 6 weeks after surgery

  2. 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

  3. Breast conservation rate.

    The breast conservation rate after treatment.

    Measured: within 6 weeks after surgery

  4. 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

  5. Overall Survival (OS).

    The OS is defined as the time from registration to death, irrespective of cause.

    Measured: 5 years

  6. Biomarkers

    Biomarkers: e.g. Tils

    Measured: 5 years

  7. 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.

  1. First posted21 Dec 2021
  2. Study start13 Jul 2021
  3. Primary completion30 Sep 2023
  4. Study completion31 Mar 2028 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

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 9 inclusion and 9 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 16 Sep 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?

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?

Residual cancer burden 0/1 (RCB-0/1) rate (time frame: within 6 weeks after surgery). 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 NCT05165225.

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 16 Sep 2026.

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