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Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)

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ClinicalTrials.gov Identifier: NCT03080805
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
HER2 Positive Metastatic Breast Cancer Drug: Pyrotinib Plus Capecitabine Drug: Lapatinib Plus Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pyrotinib Plus Capecitabine Drug: Pyrotinib Plus Capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/ m^2 BID)

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




Primary Outcome Measures :
  1. Progression Free Survival(PFS) [ Time Frame: Estimated 10 months ]
    From infromed consent to progression or death


Secondary Outcome Measures :
  1. Safety: AE [ Time Frame: AE recorded from infromed consent to 28 days after treatment completion ]
    AE

  2. Overall Survival (OS) [ Time Frame: Estimated 30 months ]
    From infromed consent to death

  3. Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ]
    CR+PR

  4. Time to Progression (TTP) [ Time Frame: Estimated 10 months ]
    From infromed consent to progression

  5. Duration of Response (DOR) [ Time Frame: Estimated 10 months ]
    CR+PR+SD

  6. Clinical Benefit rate (CBR) [ Time Frame: Estimated 10 months ]
    CR+PR+SD≥24 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03080805


Locations
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China, Beijing
Cancer Institute and Hospital,Chinese Academy of Medical Science
Beijing, Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03080805    
Other Study ID Numbers: HR-BLTN-Ⅲ-MBC
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors