A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer

NCT02362958 | Completed Phase 2 DMC

• 1 other identifier: SYSUCC-005
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

Conditions

HER2 Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  The time from randomization to disease progression or death from any causes

  36 months

Study Arms (1)

Lapatinib and Capecitabine or Vinorelbine

EXPERIMENTAL

Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)

Drug: lapatinib and capecitabine or vinorelbine

Interventions

lapatinib and capecitabine or vinorelbine DRUG

lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)

Also known as: Tykerb; Xeloda;NVB

Lapatinib and Capecitabine or Vinorelbine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic breast cancer
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• HER2-expressing primary or metastatic tumor
• Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
• Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
• Signed and dated an informed consent form
• Life expectancy of at least 12 weeks

You may not qualify if:

• Pregnant or breast feeding
• left ventricular ejection fraction (LVEF) \< 45% by echocardiogram
• Disease-free interval (DFI) less than 12 months
• Uncontrolled medical problems
• Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
• Patients were unable or unwilling to comply with program requirements

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Duan F, Zhong M, Ma Y, Song C, Zhang L, Lin Y, Wu Z, Zhang Y, Huang J, Xu F, Shi Y, Wang S, Yuan Z, Xia W, Bi X. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: a phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022 Mar 15;22(1):271. doi: 10.1186/s12885-022-09399-2.

  PMID: 35291977 DERIVED

MeSH Terms

Interventions

Lapatinib; Capecitabine; Vinorelbine

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Zhong-Yu Yuan, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: February 13, 2015
• Study Start: January 9, 2015
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)