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Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Neoplasms

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Trial Information

Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

16 weeks

Safety Issue:

Yes

Principal Investigator

Puma

Investigator Role:

Study Director

Investigator Affiliation:

Biotechnology

Authority:

United States: Food and Drug Administration

Study ID:

3144A1-201

NCT ID:

NCT00300781

Start Date:

August 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Neoplasms
  • phase 2
  • HER2+ breast cancer
  • monotherapy neratinib
  • Breast Neoplasms
  • Neoplasms

Name

Location

Investigational siteSeattle, Washington  98166
Investigational SiteAurora, Colorado  80045
Investigational SiteZion, Illinois  60099
Investigational SiteShreveport, Louisiana  71103
Investigational SiteBaltimore, Maryland  21204
Investigational SiteBoston, Massachusetts  02118
Investigational SiteLebanon, New Hampshire  03756
Investigational SiteNew Brunswick, New Jersey  08901
Investigational SiteCleveland, Ohio  44195