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Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT03273595
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:

This is a prospective, open-label, real-word study evaluating the efficacy and safety of lapatinib in combination with chemotherapy versus trastuzumab in combination with chemotherapy in women with HER2-positive and p95HER2-positive ,or PI3K mutation, or PTEN loss breast cancer . Eligible subjects will have newly diagnosed breast cancer (Stage II-III) ; not have received systemic or local treatment . The primary endpoint was the rate of pathological complete response (pCR). The secondary objectives are to evaluate overall survival, overall response rate, clinical benefit response rate and the safety as well as tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.

Patients will receive lapatinib 1000 mg daily or trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly for a total of 12 weeks. After surgery, patients planned total duration of the anti-HER2 therapy will be one year.


Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: Lapatinib Biological: Trastuzumab Drug: Paclitaxel Drug: Epirubicin Drug: Cyclophosphamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label,Multicentre,Real-word Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as Neoadjuvant Therapy for Women With HER2-positive and p95HER2-positive,PI3K Mutation,or PTEN Loss Breast Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Biological: Trastuzumab
Drug: Paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide
Experimental: Experimental group Drug: Lapatinib
Drug: Paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide



Primary Outcome Measures :
  1. pathological complete response (pCR) [ Time Frame: at the end of week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female gender;
  • Age ≥18 years;
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  • Histologically confirmed invasive breast cancer:
  • Primary tumour greater than 2 cm diameter, measured by clinical examination and mammography or echography,
  • p95HER2 positive,or PI3K mutation,or PTEN loss
  • Over expression and/or amplification of HER2 in the invasive component of the primary tumour [Wolff et al 2006] and confirmed by a certified laboratory prior to randomisation
  • Known hormone receptor status.
  • Haematopoietic status:
  • Cardiovascular:
  • Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,
  • Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to randomization (For women of childbearing potential)
  • Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)
  • Signed informed consent form (ICF)
  • Patient accepts to make available tumour samples for submission to central laboratory to conduct translational studies as part of this protocol

Exclusion Criteria:

  • Received any prior treatment for primary invasive breast cancer;
  • Previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated:
  • Basal and squamous cell carcinoma of the skin;
  • Carcinoma in situ of the cervix.
  • Patients with a prior malignancy diagnosed more than 10 years prior to randomisation may enter the study. Patients must have been curatively treated with surgery alone. Radiation therapy or systemic therapy (chemotherapy or endocrine) are NOT permitted. Prior diagnoses of breast cancer or melanoma are excluded.
  • Diagnosis of inflammatory breast cancer;
  • Bilateral cancer;
  • This criterion has been deleted from the protocol Version 1. Patients with multi-focal cancer are no longer excluded.
  • Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic therapy with oxygen;
  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;
  • Unresolved or unstable, serious adverse events from prior administration of another investigational drug;
  • Active or uncontrolled infection;
  • Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
  • Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);
  • Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or their excipients;
  • Pregnant or lactating women;
  • Concomitant use of CYP3A4 inhibitors or inducers

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): NCT03273595


Contacts
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Contact: Rui Ling, Doctor +862984775271 lingrui0105@163.com
Contact: Juliang Zhang, Doctor +862984775271 zhangjl@fmmu.edu.cn

Locations
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China, Shanxi
Xijing Hospital Recruiting
Xi'an, Shanxi, China, 710032
Contact: Juliang Zhang, Doctor    +862984775271    zhangjl@fmmu.edu.cn   
Principal Investigator: Juliang Zhang, Doctor         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Rui Ling, Doctor Xijing Hospital

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03273595     History of Changes
Other Study ID Numbers: KY20162048-1
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Cyclophosphamide
Trastuzumab
Lapatinib
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors