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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04034589
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : December 22, 2020
Information provided by (Responsible Party):
Ying Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:
HR+/HER2+(Human epidermal growth factor receptor 2 positive and hormone receptor positive)metastatic 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 inhibitors(TKI) 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) positive,hormone receptor-positive metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Pyrotinib combined with fulvestrant Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pyrotinib in Combination With Fulvestrant in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive,Hormone Receptor(HR)-Positive Metastatic Breast Cancer
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : July 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: Pyrotinib plus fulvestrant
Pyrotinib(400 mg once daily) + fulvestrant (500 mg, administered on days 0, 14 (plus or minus 3 days), 28 (plus or minus 3 days), and every 28 (plus or minus 3 days) days)
Drug: Pyrotinib combined with fulvestrant
Pyrotinib 400 mg once daily; Fulvestrant 500 mg administered on days 0, 14 (plus or minus 3 days), 28 (plus or minus 3 days), and every 28 (plus or minus 3 days) days

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Estimated 12 months ]
    From enrollment to progression or death (for any reason)

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Estimated 12 months ]
    Ratio of CR and PR in all subjects

  2. Clinical Benefit rate (CBR) [ Time Frame: Estimated 12 months ]
    Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects

  3. Overall Survival (OS) [ Time Frame: Estimated 24 months ]
    From enrollment to death (for any reason)

  4. Adverse Events and Serious Adverse Events [ Time Frame: From informed consent through 28 days following treatment completion ]

  5. Efficacy correlation biomarkers [ Time Frame: Estimated 12 months ]
    Next Generation Gene Sequencing(NGS) detection of tissue specimens to obtain information on drug sensitivity-related biomarkers , eg, PIK3CA, PTEN, TMB,ESR1,ESR2

  6. the quality of life [ Time Frame: Estimated 24 months ]
    All patients need to fill in the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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, ER(estrogen receptor) and/or PR(progesterone receptor) Immunohistochemical staining of more than 10% tumor cells)
  2. Aged ≥18 and ≤70 years.
  3. ECOG(Eastern Cooperative Oncology Group) performance status of 0 to 1.
  4. The life expectancy of more than 12 weeks;
  5. At least one measurable lesion exists(RECIST 1.1,Response Evaluation Criteria in Solid Tumors ), or only bone metastasis.
  6. 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
  7. Trastuzumab has not been treated in the past or only received first-line treatment for metastatic diseases.
  8. 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.
  9. Patients with adequate organ function before enrollment:

Neutrophil granulocyte≥1.5×10^9/L Platelet≥100×10^9/L Hemoglobin≥90 g/L Signed informed consent.

Exclusion Criteria:

  1. Patients who have not received trastuzumab, chemotherapy or endocrine therapy before;
  2. Patients with visceral crisis;
  3. Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption;
  4. Patients with malignant serous effusion which cannot be controlled by drainage or other methods;
  5. Less than 4 weeks from the last treatment in the last clinical trial;
  6. Receiving any other antitumor therapy;
  7. 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;
  8. Patients with serious heart disease;
  9. Allergy to Pyrotinib; the history of immunodeficiency;
  10. Known history of neurological or psychiatric disease, including epilepsy or dementia;
  11. 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;
  12. 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;
  13. Patients not eligible for this study judged by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04034589

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Contact: Ying Wang, M.D., Ph. D. 86-20-34070870
Contact: Herui Yao, M.D., Ph. D. 86-20-34070091

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Sun Yat-Sen University Cancer Center Not yet recruiting
Guangyuan, China
Contact: Zhongyu Yuan, M.D.         
Principal Investigator: Zhongyu Yuan, M.D.         
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting
Guangzhou, China
Contact: Ying Wang, M.D.,Ph.D.         
Contact: Herui Yao, M.D.,Ph.D.         
Principal Investigator: Ying Wang, M.D.,Ph.D.         
Principal Investigator: Herui Yao, M.D.,Ph.D.         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications of Results:
Other Publications:

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Responsible Party: Ying Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Identifier: NCT04034589    
Other Study ID Numbers: 2019-KY-049
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data can be obtained by writing to researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs