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

NCT03273595 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-09-06

No results posted yet for this study

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.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

Lapatinib

BIOLOGICAL

Trastuzumab

DRUG

Paclitaxel

DRUG

Epirubicin

DRUG

Cyclophosphamide

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Rui Ling, Doctor · Xijing Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273595 on ClinicalTrials.gov