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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03080805
Other study ID # HR-BLTN-?-MBC
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2017
Est. completion date March 2021

Study information

Verified date June 2020
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1 ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily).Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawalof consent.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 240
Est. completion date March 2021
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Aged =18 and =70 years.

2. ECOG performance status of 0 to 1.

3. Life expectancy of more than 12 weeks.

4. According to RECIST 1.1, at least one measurable lesion exists

5. Histologically or cytologic confirmed HER2 positive metastatic breast cancer.

6. Prior treatment with trastuzumab (=2 cycles in metastatic setting, or

=3 months in adjuvant/neoadjuvant setting) and Taxane(=2 cycles in any setting or untill unendurable AE or progression during treatment).

7. Previously reveived =2 chemotherapy regimens in metastasis setting;

8. Required laboratory values including following parameters:

ANC: = 1.5 x 10^9/L; Platelet count: = 90 x 10^9/L; Hemoglobin: = 90 g/L; Total bilirubin: = 1.5 x upper limit of normal (ULN); ALT and AST: = 2 x ULN(patients with liver metastases: =5 x ULN); BUN and Creatinine:

= 1x ULN;CCR=50 mL/min;LVEF: = 50%;QTcF: < 450 ms (male),< 470 ms(female);

9. Signed informed consent.

Exclusion Criteria:

1. Received capecitabine in metastatic setting;

2. Received HER2 targeted tyrosine kinase inhibitor (including Lapatinib, Neratinib and Pyrotinib);

3. Cumulated dosage of Doxorubincin >400 mg/m^2 or Epirubicin >800 mg/m^2 or equal dosage of other anthracycline drugs in adjuvant/neoadjuvant/metastatic setting );

4. Received surgery,chemotherapy,radiotherapy or target therapy within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization;

5. Participated in other clinical trial within 28 days prior to randomization.

6. Known dihydro pyrimidine dehydrogenase(DPD)defect;

7. CT or MRI confirmed brain metastases;

8. Bone or skin lesion as unique target lesion;

9. Second malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma;

10. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);

11. Uncontrolled third space effusion (such as pleural fluid and ascites) by drainage or other clinical intervention;

12. Receiving any other anti-tumour therapy after informed consent;

13. Unprogressed after or during the last anti-tumour therapy,according to RECIST1.1;

14. History of any kind of Heart disease,including 1)Angina pectoris; (2) Arrhythmia required medication or with clinical significance; (3) Myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by researcher as not suitable for participating in this study, etc;

15. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation;

16. History of neurological or psychiatric disorders, including epilepsy or dementia;

17. Concomitant disease judged by investigators that may bring serious harm to the safety of patients or the completion of this study;

18. All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study;

19. Any other situations judged by investigator as not suitable for participating in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pyrotinib Plus Capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/ m^2 BID)
Lapatinib Plus Capecitabine
Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)

Locations

Country Name City State
China Cancer Institute and Hospital,Chinese Academy of Medical Science Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival(PFS) From infromed consent to progression or death Estimated 10 months
Secondary Safety: AE AE AE recorded from infromed consent to 28 days after treatment completion
Secondary Overall Survival (OS) From infromed consent to death Estimated 30 months
Secondary Objective Response Rate (ORR) CR+PR Estimated 10 months
Secondary Time to Progression (TTP) From infromed consent to progression Estimated 10 months
Secondary Duration of Response (DOR) CR+PR+SD Estimated 10 months
Secondary Clinical Benefit rate (CBR) CR+PR+SD=24 weeks Estimated 10 months
See also
  Status Clinical Trial Phase
Recruiting NCT04829604 - ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) Phase 2
Active, not recruiting NCT03691051 - A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer Phase 2
Active, not recruiting NCT02422199 - A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab Phase 1/Phase 2
Terminated NCT01495884 - The Myocet/Lapatinib Study. ICORG 10-03, V5 Phase 1/Phase 2
Active, not recruiting NCT02973737 - A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Phase 3
Completed NCT04398108 - A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC Phase 1
Active, not recruiting NCT04681287 - Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. Phase 2