Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00300781
First received: March 7, 2006
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced HER2+ (human epidermal growth factor 2) breast cancer.


Condition Intervention Phase
Breast Neoplasms
Neoplasms
Drug: HKI-272 (neratinib)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • 16 week progression-free survival (PFS) rate of neratinib in women with Her2+ b.c., either with prior Herceptin or no prior Herceptin therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of neratinib through monitoring of data collected at biweekly intervals after first dose of study treatment. [ Time Frame: 2 years (average) ] [ Designated as safety issue: Yes ]
  • Health outcomes profile using EQ5-D, EORTC BR23 at screening, Day 1 of Month 3, Month 5 and at final visit. [ Time Frame: 2 years (average) ] [ Designated as safety issue: Yes ]
  • Objective response rate, for women with prior/no prior Herceptin exposure by independent assessment of tumor scans collected every 8 weeks on study. [ Time Frame: 2 years (average) ] [ Designated as safety issue: Yes ]
  • Clinical benefit rate (CR +PR +SD), for women with prior/no prior Herceptin exposure by independent assessment of tumor scans collected every 8 weeks on study. [ Time Frame: 2 years (average) ] [ Designated as safety issue: Yes ]
  • Duration of response for women with prior/no prior Herceptin exposure by independent assessment of tumor scans collected every 8 weeks on study. [ Time Frame: 2 years (average) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic HKI-272 plasma concentration and HKI-272 metabolites, collecting samples Day 1 predose, Day 29 predose, 2, 7 and 21-24 hours post dose and Day 1 of Month 3, 4, 5 and 6 pre-dose. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 137
Study Start Date: August 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patients with confirmed HER+ breast cancer with prior trastuzumab treatment.
Drug: HKI-272 (neratinib)
80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen.
Experimental: B
Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.
Drug: HKI-272 (neratinib)
80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen.

Detailed Description:

Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
  • Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
  • Over-expression of HER2
  • Tumor tissue available and adequate for analysis at screening
  • At least one measurable lesion

Exclusion Criteria:

  • Prior treatment with Herceptin (Arm B only)
  • More than 4 prior cytotoxic chemotherapy regimens
  • Subjects with bone or skin as the only site of measurable disease
  • Inadequate cardiac function
  • Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
  • Active central nervous system metastases
  • Pregnant or breastfeeding women
  • Inability to swallow the HKI-272 capsules
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300781

  Show 34 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00300781     History of Changes
Other Study ID Numbers: 3144A1-201, B1891012
Study First Received: March 7, 2006
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
phase 2
HER2+ breast cancer
monotherapy neratinib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014