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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: January 28, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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 2013
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
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: January 28, 2013
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 May 16, 2013