A phase II study evaluating the efficacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients after progression of chemotherapy or hormonal treatment in combination with lapatinib for metastatic disease

CECOG0 sites30 target enrollmentMay 4, 2010

Conditionsmetastatic breast cancer

DrugsTyverb 250 mg film coated tablets Navelbine 50 mg concentrate for solution for infusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: metastatic breast cancer
Sponsor: CECOG
Enrollment: 30
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 4, 2010

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

CECOG

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent obtained prior to any study\-specific procedure.
•2\. Females \=18 years.
•3\. Histologically or cytologically confirmed, HER2\-positive (HER\+\+\+ or HER\+\+ and FISH positive), adenocarcinoma of the breast with measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.
•4\. Presence of at least one measurable lesion according to RECIST Criteria version 1\.1\. (target lesion(s) must not lie within an irradiated area)
•5\. Able to comply with the protocol.
•6\. Prior treatment with a combination therapy including lapatinib as first or second\-line treatment for metastatic disease.
•7\. ECOG performance status of 0–1\.
•8\. Life expectancy more than 12 weeks.
•9\. Adequate left ventricular ejection function at baseline, defined as LVEF \= 50% by either echocardiogram or MUGA.
•10\. Adequate hematological function

Exclusion Criteria

•1\. Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 1 week prior to first study drug administration
•2\. Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above). Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that
•– not more than 30% of marrow\-bearing bone was irradiated
•– the last fraction of radiotherapy was administered \= 3 weeks prior to first dose of Lapatinib.
•3\. Other primary tumors/hematologic malignancies within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
•4\. Pre\-existing peripheral neuropathy NCI CTCAE grade \> 2 at first study drug administration
•5\. Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases. If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to frist study drug administration to rule out spinal / CNS metastases.
•6\. 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)
•7\. History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
•8\. Active infection requiring i.v. antibiotics at first study drug administration.