Puman-NER-1301 Nala

Eine Studie zum Vergleich von Neratinib plus Capecitabin mit Lapatinib plus Capecitabin  bei Patientinnen und Patienten mit metastasiertem HER2+ Mammakarzinom, die bereits zwei oder mehr gegen HER2 gerichtete Therapieschemata zur Behandlung des metastasiertem Tumors erhalten haben (NALA).

Arm A: neratinib (240 mg täglich) + capecitabine (1500 mg/m^2 täglich, 750 mg/m^2 twice daily [BID])

Arm B: lapatinib (1250 mg täglich) + capecitabine (2000 mg/m^2täglich, 1000 mg/m^2 BID)

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA)

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

Patients will be randomized in a 1:1 ratio to one of the following treatment arms:

• Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2 twice daily [BID])
• Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)

Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

Eligible for Study:  

Inclusion Criteria:

• Aged ≥18 years at signing of informed consent.
• Histologically confirmed MBC, current stage IV.
• Documented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+).
• Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion Criteria:

• Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.