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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer

Clinicaltrials.gov identifier NCT03923166

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted April 22, 2019

Study Description

Brief summary:

Overexpression of the HER2 gene accounts for 20% to 30% of breast cancer. Although trastuzumab combined with chemotherapy has become the basic treatment for patients with HER2-positive advanced breast cancer, For patients who have progressed or relapsed after trastuzumab treatment, There are still many issues to explore on the choice of program of retargeted therapy. In HER2-positive advanced breast cancer, the results of Phase I and Phase I/II trials of pyrotinib or pyrotinib combined with capecitabine show that the anti-tumor effect is rapid, efficient and sustainable, and the patient is safe and well tolerated. Capecitabine is an oral cytotoxic drug that has high selectivity and specificity against tumors. Many patients need to adjust the dose due to adverse reactions, especially for patients after multi-line treatment. Previous studies have shown that sustained low-dose capecitabine reduces the adverse effects of the drug while ensuring efficacy. Based on the above, this study is to conduct a single-center, one-arm phase II clinical trial to explore the efficacy and safety of pyrotinib and capecitabine in the treatment of HER2-positive advanced breast cancer.

  • Condition or Disease:Breast Cancer
  • Intervention/Treatment: Drug: Pyrotinib
    Drug: capecitabine
  • Phase: Phase 2
Detailed Description


Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 35 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer: Single Arm, Single Center, Phase II Clinical Trial.
  • Estimated Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: pyrotinib+ capecitabine
Drug: Pyrotinib
400mg qd

Drug: capecitabine
capecitabine 500mg tid
Outcome Measures
  • Primary Outcome Measures: 1. Objective Response Rate(ORR) [ Time Frame: 4 months ]
    Refers to the proportion of patients whose tumors have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
  • Secondary Outcome Measures: 1. Progression Free Survival(PFS) [ Time Frame: 4 months ]
    the date from the first dose to the first occurrence of disease progression or death from any cause, whichever occurs first
  • Other Outcome Measures: 1. disease control rate(DCR) [ Time Frame: 4 months ]
    Percentage of confirmed complete remission (CR), partial remission (PR), and disease stable (SD) cases in patients with evaluable efficacy
  • 2. Incidence of adverse events [ Time Frame: 1 Month ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age:18~75 years;

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

3. A life expectancy of more than 12 weeks;

4. patients have at least one measurable lesion exists according to Response Evaluation
Criteria In Solid Tumors (RECIST) 1.1 criteria and progresses after the last
anti-tumor treatment or during treatment;

5. Pathologically confirmed HER2-expressing patients with locally advanced or metastatic
breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification

6. Progression after treatment with trastuzumab (receiving at least 6 weeks of
trastuzumab treatment);

7. Have not received capecitabine for the past, or Previously received capecitabine and
PFS for more than 6 months;

8. echocardiography indicates that LVEF ≥ 50%;

9. The laboratory tests confirmed that the bone marrow function and liver and kidney
function of the patient met the following requirements before the first dose:

1. ANC≥1.5×10^9/L;

2. PLT≥100×10^9/L;

3. Hb≥100 g/L

4. serum creatinine(Scr) less than 1.5 times the upper limit of normal value or the
creatinine clearance rate calculated greater than 60 mL/min;

5. total bilirubin less than 1.5 times the upper limit of normal value

6. aspartate aminotransferase (AST), or alanine aminotransferase (ALT) less than 2.5
times the upper limit of normal value, less than 5 times the upper limit of
normal value in patients with liver metastases;

7. urine routine test with urinary protein more than ++, or 24 hour urinary protein
more than 1.0 g;

10. Females of childbearing potential must be a pregnancy test in 7 days before
participating ( including serum or urine), and the results were negative, and they are
willing to take effective contraceptive methods during the trial;

11. The patient volunteered to join the study and signed an informed consent form.

Exclusion Criteria:

1. Patients who have been treated with capecitabine for a period of 6 months and whose
disease progresses;

2. Previously treated with pyrotinib or neratinib;

3. Patients with high blood pressure who are not well controlled by antihypertensive
medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);
have uncontrolled or severe cardiovascular disease, such as within 6 months before
screening Refractory angina pectoris, congestive heart failure occurred; myocardial
infarction occurred within 12 months before screening; any clinically significant
ventricular arrhythmia history, QT interval prolongation; history of cerebrovascular
accident, symptomatic and need Medically treated coronary heart disease;

4. having significant clinical dysfunction of the digestive tract may affect the intake,
transport or absorption of oral medications (eg, inability to swallow, chronic
diarrhea, intestinal obstruction, etc.)

5. Refractory, 2 degrees and above persistent diarrhea;

6. exiting unstable brain metastasis and / or meningeal metastasis;

7. Have undergone major surgery or severe traumatic injury, fracture, or healed wound
within 4 weeks;

8. Allergic to pyrotinib, capecitabine and/or its excipients has been confirmed;

9. Female patients during pregnancy or lactation, female patients with fertility and
positive pregnancy test, or women of childbearing age who are unwilling to take
effective contraceptive measures during the whole trial period;

10. The patient has a severe concomitant disease, or any other condition that the
investigator believes is not suitable for the study.

Contacts and Locations

Contact: Binghe Xu 8687788826 ext 8687788826 xubinghe@medmall.com

Contact: Qiao Li 8687788120 ext 8687788120 Liqiaopumc@qq.com


China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsors and Collaborators

Chinese Academy of Medical Sciences


Principal Investigator: Qiao Li Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Principal Investigator: Binghe Xu Cancer Institute and Hospital, Chinese Academy of Medical Sciences

More Information
  • Responsible Party: Chinese Academy of Medical Sciences
  • ClinicalTrials.gov Identifier: NCT03923166 History of Changes
  • Other Study ID Numbers: LQ006
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: April 22, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms