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

Phase 1

• Conditions: Trastuzumab-resistant HER2-overexpressing metastatic breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000598-22-DE
• Lead Sponsor: Berufsverband der niedergelassenen gynäkologischen Onkologen in Deutschland e.V.; BNGO e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-15
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

•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)
•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. Malabsorption syndrome or other condition that would interfere with enteral absorption
•8. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
•9. Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
•10. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified