West Cancer Center

BREAST: Metastatic: HER2+; >or=3rd line; "NALA"

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).

Title

Puma NER-1301

Study Title

Site Link

NCT01808573

Malignancy

Breast, Metastatic HER2 positive Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>2nd line

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

Greg Vidal, MD, PhD

Sponsor

Puma Biotechnology

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT01808573

Key Eligibility Criteria Details

Metastatic breast cancer

HER2 overexpression or gene amplified tumor (IHC3+ or IHC2+ with positive FISH)

Prior treatment with at least 2 HER2-directed regimens for metastatic breast cancer

Measurable disease per RECIST 1.1

ECOG PS 0-1

No prior therapy with capecitabine, neratinib, lapatinib, or other HER2 directed TKI.

No active (symptomatic CNS mets)

No significant chronic GI disorder with diarrhea as a major symptom

Objective

Primary- PFS and OS: Secondary: investigator assessed PFS, ORR, DOR, CBR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2+

Dosing Frequency

Neratinib 240mg PO qday on each of 21 day cycle. Capecitabine 750mg/m2 PO bid on days 1-14 of 21 day cycle

Control Agents

Lapatinib 1250mg PO qday on each of 21 day cycle. Capecitabine as per intervention arm.

Study Protocol

Randomized