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

Phase 2
18 Years
Open (Enrolling)
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:


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:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

December 2013

Related Keywords:

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



Investigational site Seattle, Washington  98166
Investigational Site Aurora, Colorado  80045
Investigational Site Zion, Illinois  60099
Investigational Site Shreveport, Louisiana  71103
Investigational Site Baltimore, Maryland  21204
Investigational Site Boston, Massachusetts  02118
Investigational Site Lebanon, New Hampshire  03756
Investigational Site New Brunswick, New Jersey  08901
Investigational Site Cleveland, Ohio  44195