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Trial record 1 of 1 for:    NCT00300781
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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: August 10, 2017
Last verified: August 2017
  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: neratinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 [ Time Frame: From first dose to 16 weeks ]
    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.


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: From first dose date to progression or last tumor assessment ]
    Objective response rate of PR or CR by independent assessment of tumor

  • Clinical Benefit Rate [ Time Frame: From first dose date to progression or last tumor assessment ]
    Clinical benefit rate (CR, PR, or SD ≥ 24 weeks) by independent assessment

  • Duration of Response [ Time Frame: From start date of response to first PD/death ]
    The duration of response is measured from the time criteria are met for CR or PR until the first date of PD or death


Enrollment: 137
Actual Study Start Date: August 2006
Estimated Study Completion Date: December 2018
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neratinib 240 mg, with prior trastuzumab
Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
Drug: neratinib
Other Names:
  • Nerlynx
  • HKI-272
Experimental: Neratinib 240 mg, no prior trastuzumab
Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
Drug: neratinib
Other Names:
  • Nerlynx
  • HKI-272

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   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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 33 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

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
Results First Received: August 10, 2017
Last Updated: August 10, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Puma Biotechnology, Inc.:
phase 2
HER2+ breast cancer
monotherapy neratinib
HKI-272
Neratinib
Nerlynx
PB-272

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 21, 2017