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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300781
• Other study ID #: 3144A1-201 / B1891012
• Status: Completed
• Phase: Phase 2
• Start date: August 4, 2006
• Est. completion date: January 30, 2018

Study information

• Verified date: August 2018
• Source: Puma Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 30, 2018
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms

Intervention

Drug:
• neratinib

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet Unite du Chimiotherapie	Brussels
Belgium	University Hospital Gasthuisberg	Leuven
Belgium	St-Augustinus Ziekenhuis Oncology Department	Wilrijk
China	Cancer Hospital Peking Union Medical College	Beijing
China	Chinese People's Liberation Army General Hospital	Beijing
China	The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army	Beijing	Beijing
China	No. 81 Hospital of Chinese People's Liberation Army	Nanjing	Jiangsu
France	Institut Gustave ROUSSY Service de Pathologie Mammaire	Villejuif Cedex
India	Nizam's Institute of Medical Sciences	Hyderabad	Panjagutta
India	Tata Memorial Centre	Mumbai	Parel
India	Deenanath Mangeshkar Hospital	Pune	Maharashtra
India	Jehangir Clinical Development Centre	Pune	Maharashtra
Mexico	Arke Estudios Clínicos S.A. de C.V.	Mexico City
Mexico	Hospital de Especialidades MIG	Mexico City
Mexico	Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica	Mexico City
Russian Federation	N.N. Blokhin Russian Cancer Research Center of RAMS	Moscow
Russian Federation	Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods	Obninsk
Russian Federation	City Hospital N 31 Oncology Haematology Dept. For Adults	Saint Petersburg
Russian Federation	City Oncology Dispensary	Saint Petersburg
Russian Federation	Breast Tumor Department, N.N. Petrov Research Institute of Oncology	Saint-Petersburg
United States	University of Colorado Hospital	Aurora	Colorado
United States	The Cancer Center at GBMC	Baltimore	Maryland
United States	Oncology Care Associates	Bethesda	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts
United States	The Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Louisiana State University	Shreveport	Louisiana
United States	Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Puma Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  China,  France,  India,  Mexico,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	16-week Progression Free Survival	16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.	From first dose to 16 weeks
Secondary	Objective Response Rate	Percentage of participants with Partial Response (PR) or Complete Response (CR) by independent assessment of tumor per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	From first dose date to progression or last tumor assessment, up to 46 months
Secondary	Clinical Benefit Rate	Percentage of participants who experienced Complete Response (CR), Partial Response (PR), or Stable Disease (SD) = 24 weeks by independent assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.	From first dose date to progression or last tumor assessment, up to 46 months
Secondary	Duration of Response	Number of weeks between Complete Response (CR) or Partial Response (PR) and the first date of disease progression (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions	From start date of response to first PD/death, up to 46 months