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

Xijing Hospital1 site in 1 country100 target enrollmentJuly 2016

ConditionsNeoplasms, Breast

InterventionsTrastuzumab Paclitaxel Epirubicin Cyclophosphamide Lapatinib

DrugsLapatinib Paclitaxel Epirubicin Cyclophosphamide

Overview

Phase: Phase 2
Intervention: Trastuzumab
Conditions: Neoplasms, Breast
Sponsor: Xijing Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: pathological complete response (pCR)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

December 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Xijing Hospital

Responsible Party

Sponsor

Eligibility 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:

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
•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;