Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

NCT00912275 | Completed Phase 1 DMC

• 1 other identifier: 200811019M
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I part: to determine the recommended dose, and observe the preliminary response and safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase II part: to determine the progression free survival, response rate, and to evaluate the safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase I part has been completed. Phase II part is underway.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the recommended dose of the combination of oral lapatinib with vinorelbine (phase I part), and progression free survival (phase II part)

  phase I part: 4 months, phase II part: 1 and half years

Secondary Outcomes (1)

• response rate, safety profile

  2 years

Study Arms (1)

Lapatinib plus Oral Vinorelbine

EXPERIMENTAL

Oral vinorelbine on day 1 and day 8 q3w plus lapatinib 1000mg/day.

Drug: lapatinib plus oral vinorelbine

Interventions

lapatinib plus oral vinorelbine DRUG

Lapatinib -dose level -I, I, II, III 1000mg po daily;dose level IV:1250mg po daily; Oral vinorelbine at the dose level reached on days 1, and 8 of a 21 days cycle. Dose level -I:30mg/m2,I:40mg/m2,II:50mg/m2,III:60mg/m2,IV:60mg/m2,V:80mg/m2

Also known as: Tykerb, Navelbine

Lapatinib plus Oral Vinorelbine

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the breast which is now metastatic.
• Documented ErbB2 over expression or amplified disease in the invasive component of the primary or metastatic lesion as defined by:
• + over expression by IHC or
• ErbB2 gene amplification by FISH/CISH (\> 6 ErbB2 gene copies per nucleus, or a FISH ratio (ErbB2 gene copies to chromosome 17 signals) of \> than 2.2;
• In phase II part, patients must be chemo-naïve in metastatic setting. In phase I part, patient may have received prior chemotherapy including vinorelbine in metastatic setting. However, patient must be informed and well understand that in current standard of treatment, suggested first line treatments for erbB-2 positive, visceral organ metastatic breast cancer are combination of chemotherapy with herceptin.
• In phase II part, patient must not have exposed to ant-erbB2 targeted therapy treatment in metastatic setting. Herceptin treatment in the neoadjuvant or adjuvant setting is permitted provide that at least 12 months has elapsed since the last dose of herceptin therapy. In phase I part, patient may have received prior anti-erbB-2 targeted treatment in metastatic setting.
• Prior treatment with endocrine therapy in the adjuvant or metastatic setting permitted provided that therapy has been discontinued.
• Prior treatments with radiation therapy for palliative management of metastatic disease permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are \< grade 1 at the time of registration.
• Patients must have evidence of metastatic disease, but measurable disease is not mandatory. To be considered evaluable for the overall response rate (complete and partial response), patients must have at least one measurable lesion as follows:
• X-ray, physical exam \>= 20 mm
• Conventional CT scan, MRI \>= 20 mm
• Spiral CT scan \>= 10 mm
• Age \> 20 years.
• Life expectancy \> 3 months.
• ECOG PS 0-2.

You may not qualify if:

• Pregnant or lactating women.
• Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
• Prior therapy with lapatinib.
• CNS metastases.
• Ongoing anticancer treatment.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious non-healing wound/ulcer/bone fracture, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Department of Oncology,National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Yen-Shen Lu, M.D.,Ph.D

  Department of Oncology,National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: November 24, 2008
• Primary Completion: March 31, 2015
• Study Completion: July 7, 2017
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

TW (1)