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Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT04246502
Recruitment Status : Not yet recruiting
First Posted : January 29, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Zhiyong Yu, Shandong Cancer Hospital and Institute

Brief Summary:
This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Capecitabine and Pyrotinib Drug: Capecitabine,Trastuzumab, and Pertuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A Drug: Capecitabine and Pyrotinib
Pyrotinib 400mg orally daily until progressive disease

Active Comparator: B Drug: Capecitabine,Trastuzumab, and Pertuzumab
as instruction




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Approximately 42 months ]

Secondary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: From the first drug administration to within 28 days for the last treatment ]
    AEs+SAEs

  2. Overall Survival [ Time Frame: Up to 2 years ]
  3. Objective Response Rate [ Time Frame: Approximately 42 months ]
  4. Duration of Objective Response [ Time Frame: Approximately 42 months ]
  5. Clinical Benefit rate [ Time Frame: From the start of randomization to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HER2 positive recurrent or metastasis breast cancer.
  • Patients with measurable disease are eligible.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  • Adequate organ function.
  • Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

  • History of anti-cancer therapy for MBC(with the exception of one prior hormonal regimen for MBC).
  • History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting,except trastuzumab used in the neo-adjuvant or adjuvant setting.
  • Assessed by the investigator to be unable receive systemic chemotherapy.
  • History of other malignancy within the last 5 years,except for carcinoma in situ of cervix,basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
  • Pregnant or lactating women,or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
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Responsible Party: Zhiyong Yu, Shandong Breast Disease Centre, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT04246502    
Other Study ID Numbers: Shandong CHI-11
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Pertuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological