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

Sponsor
Xijing Hospital
Study ID
NCT03273595
Phase
PHASE2
Status
Unknown

Conditions

  • Neoplasms, Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
  • Trastuzumab — BIOLOGICAL
  • Paclitaxel — DRUG
  • Epirubicin — DRUG
  • Cyclophosphamide — DRUG

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
Jun 2016
Primary completion
Jul 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control
  • Experimental: Experimental group

Primary Outcome Measure

pathological complete response (pCR) [ Time Frame: at the end of week 12 ]

Central Contacts