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

Puma Biotechnology

Status and phase: Completed; Phase 2

Conditions: Neoplasms; Breast Neoplasms

Treatments: Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300781

3144A1-201 / B1891012

Details and patient eligibility

About

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

Full 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.

Enrollment: 136 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Neratinib 240 mg, with prior trastuzumab

Experimental group

Description:

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.

Treatment:

Drug: neratinib

Neratinib 240 mg, no prior trastuzumab

Experimental group

Description:

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.

Treatment:

Drug: neratinib