NCT03377387 - Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 13, 2017

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions

Breast Cancer

Interventions

DRUG

Capecitabine

Capecitabine will be taken orally in AM and PM (at the assigned dose per cohort) 7 days on and 7 days off. Phase II MD 1000mg BID of capecitabine.

DRUG

Neratinib

Neratinib is given as 240 mg daily continuously without stopping. A cycle is 28 days. Phase II The MD has been determined as 240mg of neratinib

BEHAVIORAL

EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30

Questionnaires Every Cycle (+/- 3 days) (For phase II)

Trial Locations (10)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

18103

Lehigh Valley Health Network, Allentown

33143

Baptist Alliance - McI, Miami

06102

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford

07920

Memorial Sloan Kettering at Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors

collaborator

Puma Biotechnology, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER