Randomised, open-label phase II study to compare the safety and efficacy of lapatinib plus trastuzumab or lapatinib plus capecitabine in trastuzumab-resistant HER2-overexpressing metastatic breast cancer - THOR

Berufsverband der niedergelassenen gynäkologischen Onkologen in Deutschland e.V.; BNGO e.V.0 sites100 target enrollmentFebruary 15, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Berufsverband der niedergelassenen gynäkologischen Onkologen in Deutschland e.V.; BNGO e.V.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

February 15, 2013

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Berufsverband der niedergelassenen gynäkologischen Onkologen in Deutschland e.V.; BNGO e.V.

•Women with histologically confirmed breast cancer; measurable metastatic disease; HER2\-positive (IHC 3\+ or ISH positive); Hormone receptor\-negative; prior treatment with trastuzumab, anthracycline and taxanes; progression on trastuzumab as first\-line or second\-line therapy; no prior treatment with lapatinib within last 6 months; Adequate hematologic, renal and liver function; normal cardiac function with LVEF of \=50%; ECOG performance status 0\-1; No evidence of brain metastases (asymptomatic metastases that have been clinically stable for 3 months are allowed); no significant cardiovascular disease or other serious medical condition; written informed consent to participate in the trial and to the donation of formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer available for central testing.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 100
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\. Patients with confirmed brain metastases or a history of primary central nervous system tumours or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Patients with treated brain metastases that are asymptomatic and have been clinically stable for 3 months will be eligible for protocol participation.
•2\. Hormone receptor\-positive patients or prior treatment with lapatinib within the last 6 months
•3\. More than 2 line of trastuzumab\-based treatment for advanced disease
•4\. Significant cardiovascular disease, such as
•?History of myocardial infarction, acute coronary syndromes (including unstable angina), or history of coronary angioplasty/stenting/bypass grafting within past 6 months.
•?History of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) Classes II\-IV or LVEF \<50% by either ECHO or MUGA
•?Severe cardiac arrhythmia requiring medication or severe conduction abnormalities
•?Poorly controlled hypertension (resting diastolic blood pressure \>100 mmHg)
•?Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy
•5\. QTc prolongation defined as a QTc interval \>460 msecs or other significant ECG abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate \<50 beats/min)