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

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Hengrui Medicine

Status and phase

Phase 3


HER2 Positive Metastatic Breast Cancer


Drug: Lapatinib Plus Capecitabine
Drug: Pyrotinib Plus Capecitabine

Study type


Funder types




Details and patient eligibility


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.


240 estimated patients




18 to 70 years old


No Healthy Volunteers

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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

240 participants in 2 patient groups

Pyrotinib Plus Capecitabine
Experimental group
Drug: Pyrotinib Plus Capecitabine
Lapatinib Plus Capecitabine
Active Comparator group
Drug: Lapatinib Plus Capecitabine

Trial contacts and locations



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