Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)
HER2 Positive Metastatic Breast Cancer
About this trial
This is an interventional treatment trial for HER2 Positive Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- According to RECIST 1.1, at least one measurable lesion exists
- Histologically or cytologic confirmed HER2 positive metastatic breast cancer.
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).
- Previously reveived ≤2 chemotherapy regimens in metastasis setting;
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);
- Signed informed consent.
Exclusion Criteria:
- Received capecitabine in metastatic setting;
- Received HER2 targeted tyrosine kinase inhibitor (including Lapatinib, Neratinib and Pyrotinib);
- 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 );
- Received surgery,chemotherapy,radiotherapy or target therapy within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization;
- Participated in other clinical trial within 28 days prior to randomization.
- Known dihydro pyrimidine dehydrogenase(DPD)defect;
- CT or MRI confirmed brain metastases;
- Bone or skin lesion as unique target lesion;
- Second malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
- Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
- Uncontrolled third space effusion (such as pleural fluid and ascites) by drainage or other clinical intervention;
- Receiving any other anti-tumour therapy after informed consent;
- Unprogressed after or during the last anti-tumour therapy,according to RECIST1.1;
- 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;
- History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation;
- History of neurological or psychiatric disorders, including epilepsy or dementia;
- Concomitant disease judged by investigators that may bring serious harm to the safety of patients or the completion of this study;
- 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;
- Any other situations judged by investigator as not suitable for participating in this study.
Sites / Locations
- Cancer Institute and Hospital,Chinese Academy of Medical Science
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pyrotinib Plus Capecitabine
Lapatinib Plus Capecitabine