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A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer

NCT00398567•Puma Biotechnology, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

Detailed Description

Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with IV trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer. Three to six subjects will be enrolled in each dose group. Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21. When the maximum tolerated dose (MTD) of HKI-272 plus trastuzumab is determined, an additional 30 subjects will be enrolled at that dose level, and followed for progression free survival for approximately 1 year.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy
•Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
•HER2 positive breast cancer
•At least one measurable target lesion
•Adequate performance status
•Adequate cardiac, kidney, and liver function
•Adequate blood counts
•Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control

Exclusion Criteria

•More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
•Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1
•Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2
•Extensive visceral disease
•Active central nervous system metastases
•Pregnant or breast feeding women
•Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
•Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)
•Significant cardiac disease or dysfunction
•History of life-threatening hypersensitivity to Herceptin
+2 more criteria

Locations (14)

City of Hope National Medical Center

Duarte, California, United States

LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

City of Hope National Medical Center

Pasadena, California, United States

University of Maryland, University of Maryland Medical Center

Baltimore, Maryland, United States

Duke University, Duke University Medical Center

Durham, North Carolina, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Chinese Nanjing Bayi Hospital

Nanjing, Jiangsu, China

Tianjin Union Medicine Center

Tianjin, Tianjin Municipality, China

Cancer Hospital, Academy of Med Science and Peking Union Med

Beijing, China

307 Hospital of Chinese People's Liberation Army

Beijing, China

Key Dates

Start Date

April 4, 2007

Primary Completion Date

July 31, 2009

Completion Date

March 2, 2018

Last Updated

July 24, 2018

Enrollment

ACTUAL participants

Conditions

Advanced Breast Cancer

Interventions

HKI-272

DRUG

trastuzumab

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers