Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive HR-Positive Metastatic Breast Cancer

  • End date
    Jul 6, 2022
  • participants needed
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Updated on 27 January 2021
measurable disease
breast cancer
growth factor
endocrine therapy
hormone therapy
tumor cells
epidermal growth factor receptor
bone metastases
human epidermal growth factor
progesterone receptor
estrogen receptor
immunological adjuvant


HR+/HER2+Human epidermal growth factor receptor 2 positive and hormone receptor positivemetastatic breast cancer is a special subtype of HER2+breast cancer. Conventional guidelines recommend chemotherapy combined with trastuzumab targeted therapy for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Pyrotinib is a new class I small molecule Tyrosine kinase inhibitorsTKI drug with high efficacy and low toxicity after the progress of trastuzumab therapy. Fulvestrant is the most preferred single-drug therapy for HR + metastatic breast cancer recommended unanimously by the guidelines, and fulvestrant and small molecule TKI have synergistic effects. Therefore, we envisage that fulvestrant combined with Pyrotinib in the treatment of HR+/HER2+ metastatic breast cancer in clinical practice has the advantages of improving efficacy and survival. To this end, we intend to conduct a prospective, multi-center, phase II clinical trial to evaluate the efficacy and safety of erlotinib in combination with fulvestrant in patients with human epidermal growth factor receptor 2 (HER2) positivehormone receptor-positive metastatic breast cancer.

Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment Pyrotinib combined with fulvestrant
Clinical Study IdentifierNCT04034589
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on27 January 2021


Yes No Not Sure

Inclusion Criteria

Pathologically confirmed HER2 positive, hormone receptor-positive patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification, ERestrogen receptor and/or PRprogesterone receptor Immunohistochemical staining of more than 10% tumor cells)
Aged 18 and 70 years
ECOGEastern Cooperative Oncology Group performance status of 0 to 1
The life expectancy of more than 12 weeks
At least one measurable lesion exists(RECIST 1.1Response Evaluation Criteria in Solid Tumors ), or only bone metastasis
Previous neoadjuvant or adjuvant use of trastuzumab, but the disease-free interval between the end of the last trastuzumab and the progression of tumors was more than 12 months
Trastuzumab has not been treated in the past or only received first-line treatment for metastatic diseases
It is required that previous (neo) adjuvant or endocrine therapy be given to patients, and that progress of the disease occur during or after treatment
Patients with adequate organ function before enrollment
Neutrophil granulocyte1.510^9/L Platelet10010^9/L Hemoglobin90 g/L Signed
informed consent

Exclusion Criteria

Patients who have not received trastuzumab, chemotherapy or endocrine therapy before
Patients with visceral crisis
Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption
Patients with malignant serous effusion which cannot be controlled by drainage or other methods
Less than 4 weeks from the last treatment in the last clinical trial
Receiving any other antitumor therapy
History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent
Patients with serious heart disease
Allergy to Pyrotinib; the history of immunodeficiency
Known history of neurological or psychiatric disease, including epilepsy or dementia
Patients during pregnancy or lactation, patients with childbearing potential tested positive in a baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial
Evidence of significant medical illness that will substantially increase the risk of the participation or completion of the study in the investigator's judgment. Examples included, but not limited to, hypertension, severe diabetes, etc
Patients not eligible for this study judged by the investigator
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