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Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

NCT01670877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-04-15

Study results available
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Summary

This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Neratinib

DRUG

Fulvestrant

DRUG

Trastuzumab

PROCEDURE

Tumor biopsy

-Optional at baseline and disease progression

PROCEDURE

Research blood sample

-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Cynthia Ma, M.D., Ph.D · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-11
Primary Completion
2021-02-11
Completion
2021-03-11
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670877 on ClinicalTrials.gov