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 : Unknown
Verified June 2020 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : June 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HER2 Positive Metastatic Breast Cancer | Drug: Pyrotinib Plus Capecitabine Drug: Lapatinib Plus Capecitabine | Phase 3 |
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 |
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) |
- Progression Free Survival(PFS) [ Time Frame: Estimated 10 months ]From infromed consent to progression or death
- Safety: AE [ Time Frame: AE recorded from infromed consent to 28 days after treatment completion ]AE
- Overall Survival (OS) [ Time Frame: Estimated 30 months ]From infromed consent to death
- Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ]CR+PR
- Time to Progression (TTP) [ Time Frame: Estimated 10 months ]From infromed consent to progression
- Duration of Response (DOR) [ Time Frame: Estimated 10 months ]CR+PR+SD
- Clinical Benefit rate (CBR) [ Time Frame: Estimated 10 months ]CR+PR+SD≥24 weeks
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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 |
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;
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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.
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
China, Beijing | |
Cancer Institute and Hospital,Chinese Academy of Medical Science | |
Beijing, Beijing, China |
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 |
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 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine Lapatinib |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |