CClinicalTrials.gg
RecruitingNCT04481932Updated Jul 22, 2020

Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer

A Phase 2 interventional study of Trastuzumab combined with Pyrotinib and chemotherapy in HER2-positive Breast Cancer, sponsored by Peking University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Peking University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2022, 4 years 4 months ago, but the record still lists the study as recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate (pCR) for adenocarcinoma.

Read the detailed description

This study is a single-arm, open, phase II clinical study. The subjects are patients with locally advanced, inflammatory, or early HER2-positive breast cancer. The patients enter the trial period after signing informed consent. This study aims to evaluate trastuzumab The pathological complete response rate (pCR) of anti-combined pyrrotinib and chemotherapy (TCbH+Py) in the treatment of HER2-positive breast cancer.

The subjects began to take continuous medication after joining the group, and the total duration of medication was 6 cycles. Three to four weeks after the end of treatment, the surgeon will choose radical mastectomy, modified radical mastectomy or breast-sparing surgery according to the individual conditions of the patient. Regardless of whether the pCR is achieved, the adjuvant trastuzumab therapy or trastuzumab plus pertuzumab therapy is continued after the operation, and the total course of anti-HER2 therapy is up to 1 year (about 18 treatment cycles). According to the clinical stage and molecular classification of the tumor, it is necessary to decide whether adjuvant radiotherapy, chemotherapy and endocrine therapy are needed.

After the subject finishes all treatments, the subjects who are out of the group for non-PD and non-death causes need to receive the validity Follow-up until PD, start receiving other anti-tumor drug treatment or death (whichever comes first).

02

Conditions studied

  • HER2-positive Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 104 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Female between 18 and 70 years old;
  2. Histologically confirmed as invasive breast cancer;
  3. ECOG PS 0-1;
  4. The expected survival time is not less than 12 weeks;
  5. Standard immunohistochemical HER2-positive breast cancer patients (IHC +++ or FISH amplification);
  6. The status of hormone receptors (ER and PR) can be known.
  7. Clinical examination or imaging examination of primary lesion >2cm;
  8. Patients who are operable (T2-3, N0-1, M0), locally advanced (T2-3,N2-3, M0 or T4A-C, any N, M0) or inflammatory breast cancer (T4d, any N, M0) and who have not received any previous anti-tumor therapy (including radiotherapy, chemotherapy, targeted therapy, except those who have received bisphosphonate therapy previously);
  9. Echocardiography indicated left ventricular ejection fraction (LVEF)≥55%;
  10. Adequate organ and bone marrow function, as defined below: a. Neutrophil count (ANC)≥ 1,500/mm3 (1.5 × 109/L); B. Platelet count (PLT)≥ 100,000/mm3(100 × 109/L); C. Hemoglobin (Hb)≥ 9 g/dL(90 g/L); D. Serum creatinine ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥ 60 ml/min(based on Cockroft - Gault formula); E. Total bilirubin (BIL)≤ 1.5 times the upper limit of normal value (ULN); F. AST/SGOT or ALT/SGPT ≤ 2.5 times upper limit of normal value (ULN);G. Urinary protein \<2+; If urinary protein ≥2+, 24-hour urinary protein quantification shows protein must1 g or less;
  11. I have agreed and signed the informed consent, and am willing and able to comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion criteria

Exclusion Criteria:

  1. Have received any previous anti-tumor treatment for primary invasive breast cancer;
  2. Previous (\<10 years) or other malignant tumors, except for curable cancer species: a. basal cell carcinoma of skin and squamous cell carcinoma b. Carcinoma in situ of cervix
  3. For patients with other malignancies, they can also be included in the study if the time from diagnosis to enrollment exceeds 10 years; Prior surgical treatment is permitted except for radiotherapy or systemic therapy (chemotherapy or endocrine therapy);
  4. Metastatic breast cancer (M1), bilateral or ipsilateral multifocal breast cancer;
  5. Uncontrolled hypertension, systolic blood pressure > 150 MMHG and/or diastolic blood pressure > 100 MMHG), or clinical symptomatic cardiovascular disease, myocardial ischemia and myocardial infarction, severe/unstable angina, poor control of cardiac arrhythmias (including women according to Bazett formula correction QTc interphase \< 470 ms), symptoms of congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic cerebral embolism), NYHA Ⅱ magnitude cardiac insufficiency;
  6. Receive other anti-tumor treatments within 4 weeks before enrollment;
  7. Inability to swallow, intestinal obstruction or other factors affecting the use and absorption of medication;
  8. Persons with allergic constitution or known history of allergy to the drug components of the program;
  9. The patient has a severe concomitant disease or other conditions that the researcher considers inappropriate for the patient to participate in the studyIn any case;
  10. Non-surgically sterilized female patients of childbearing age must have negative serum or urine HCG tests within 14 days prior to study inclusion; And must be non-lactation
  11. Other circumstances deemed inappropriate for inclusion by the researcher.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Trastuzumab combined with Pyrotinib and chemotherapy

    The dosage of the above drugs can be adjusted according to the adverse reactions of the subjects. The subject continued to use the drug until the full cycle or the disease progressed or the toxicity was intolerable or withdrawn, or the researcher judged that the medication must be terminated.

    Drug: Trastuzumab combined with Pyrotinib and chemotherapy

Interventions

  • DrugTrastuzumab combined with Pyrotinib and chemotherapy

    Pyrotinib is a small molecule, irreversible tyrosine kinase inhibitor with targets of epidermal growth factor receptor 1 (EGFR/HER1/ErbB1), human epidermal factor receptor 2 (HER2/ErbB2/Neu) and human epidermis Factor Receptor 4 (HER4/ErbB4). As a new generation of anti-HER2 therapeutic targeted drugs, pirotinib covalently binds to the ATP binding sites of the kinase regions of EGFR, HER2 and HER4 in cells to prevent homogeneity and heterogeneity of EGFR, HER2 and HER4 in tumor cells Dimer formation, inhibiting its own phosphorylation, blocking the activation of downstream signaling pathways, thereby inhibiting tumor cell growth

06

What researchers measure

Primary outcomes

  1. pathological complete response (pCR)

    Breast without invasive carcinoma and carcinoma in situ or only carcinoma in situ (ypT0 or ypT0/is)

    Time frame: From enrollment to 18 weeks

Secondary outcomes

  1. overall survival (OS)

    From the date of enrollment to the time of death due to any cause

    Time frame: At least two years

  2. Safety index

    ECOG PS score, vital signs, physical examination, laboratory examination indicators, ECG, echocardiography, adverse events (AE) according to NCI-CTC AE 5.0 standard

    Time frame: At least two years

07

Study locations

1 of 1 sites recruiting
  • Peking University Cancer Hospital
    Beijing, Beijing 100142, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04481932
Lead sponsor
Peking University
Responsible party
Tao OUYANG (Chairman of Breast Center of Peking University Cancer Hospital, Peking University) — Principal investigator
First posted
Jul 22, 2020
Start date
Jul 2020 (estimated)
Primary completion
Jun 2022 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 22, 2020

Study contacts

Tao Ouyang, MD
Contact
ouyanghongtao@263.net
88271119-5002
Tao Ouyang, MD
study chair · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion