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Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05346861
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Jian Zhang,MD, Fudan University

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, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy versus trastuzumab and chemotherapy in HER2+ MBC patients, who have prior received trastuzumab and pyrotinib. Patients will be randomized in a 2:1 ratio to one of the following treatment arms. Arm A: pyrotinib + trastuzumab + chemotherapy, Arm B: trastuzumab + chemotherapy. Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawal of consent.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Metastatic Breast Cancer Drug: Trastuzumab plus chemotherapy Drug: Trastuzumab in combination with pyrotinib plus chemotherapy 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: Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Active Comparator: Trastuzumab plus chemotherapy Drug: Trastuzumab plus chemotherapy
Trastuzumab: 8 mg/kg loading dose followed by 6 mg/kg, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy Experimental: Pyrotinib +Trastuzumab + chemotherapy

Experimental: Pyrotinib in combination with Trastuzumab plus chemotherapy Drug: Trastuzumab in combination with pyrotinib plus chemotherapy
Pyrotinib: 400 mg po QD, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: approximately 8 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: approximately 8 months ]
  2. Adverse Events (AEs) [ Time Frame: From the first drug administration to within 28 days for the last treatment ]


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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥18 and ≤75 years;
  2. Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;
  3. History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;
  4. History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;
  5. Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);
  6. ECOG performance status of 0 to 1;
  7. According to RECIST 1.1, at least one extracranial measurable lesion exists;
  8. Signed informed consent.

Exclusion Criteria:

  1. Patients with leptomeningeal metastasis or unstable brain metastasis;
  2. History of neurological or psychiatric disorders;
  3. Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
  4. Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.
  5. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
  6. History of allergies to the drug components of this regimen;
  7. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;
  8. 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): NCT05346861


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jian Zhang, MD,PhD    +8664175590 ext 85000    syner2000@163.com   
Sponsors and Collaborators
Fudan University
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Responsible Party: Jian Zhang,MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT05346861    
Other Study ID Numbers: YBCSG-21-01
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022

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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
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents