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

HER2 Positive Breast Cancer Clinical Trial

Official title:

Sun Yat-sen University Cancer Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362958
• Other study ID #: SYSUCC-005
• Status: Completed
• Phase: Phase 2
• Start date: January 9, 2015
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Breast Cancer

Intervention

Drug:
• lapatinib and capecitabine or vinorelbine
lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	The time from randomization to disease progression or death from any causes	36 months