Advanced Breast Cancer Clinical Trial
Official title:
A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer
Verified date | June 2018 |
Source | Puma Biotechnology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.
Status | Completed |
Enrollment | 45 |
Est. completion date | March 2, 2018 |
Est. primary completion date | July 31, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy - Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting) - HER2 positive breast cancer - At least one measurable target lesion - Adequate performance status - Adequate cardiac, kidney, and liver function - Adequate blood counts - Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control Exclusion Criteria: - More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease - Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1 - Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2 - Extensive visceral disease - Active central nervous system metastases - Pregnant or breast feeding women - Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom - Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb) - Significant cardiac disease or dysfunction - History of life-threatening hypersensitivity to Herceptin - Inability or unwillingness to swallow HKI-272 capsules - Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin |
Country | Name | City | State |
---|---|---|---|
China | 307 Hospital of Chinese People's Liberation Army | Beijing | |
China | Cancer Hospital, Academy of Med Science and Peking Union Med | Beijing | |
China | Chinese PLA General Hospital | Beijing | |
China | Chinese Nanjing Bayi Hospital | Nanjing | Jiangsu |
China | Tianjin Union Medicine Center | Tianjin | Tianjin |
France | Institut Curie | Paris | |
France | Centre Rene Gauducheau | Saint-Herblain | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
United States | University of Maryland, University of Maryland Medical Center | Baltimore | Maryland |
United States | City of Hope National Medical Center | Duarte | California |
United States | Duke University, Duke University Medical Center | Durham | North Carolina |
United States | LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center | Los Angeles | California |
United States | City of Hope National Medical Center | Pasadena | California |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Puma Biotechnology, Inc. |
United States, China, France, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 16-week Progression-free Survival (PFS) Rate | 16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population. | From first dose date to progression status (PD or death) at 16-week | |
Secondary | Objective Response Rate (ORR) | Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. | From first dose date to progression or last tumor assessment, up to five and a half years. | |
Secondary | Duration of Response (DOR) | Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date on which recurrence or PD was objectively documented, taking as the reference for PD the smallest measurements recorded since the test article administration started. | From start date of response to first PD, assessed up to five and half years after the first subject was randomized | |
Secondary | Progression Free Survival (PFS) | Progression Free Survival was measured from the date of the first dose of test article until the first date on which recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. | From first dose date to progression or death, assessed up to five and half years. | |
Secondary | Clinical Benefit Rate (CBR) | The percentage of participants with a best overall response of a complete response (CR) or partial response (PR) or stable disease (SD) >=24 weeks. | From first dose date to progression or last tumor assessment, assessed up to five and half years. | |
Secondary | Area Under the Curve of Neratinib Concentration | Area Under the Curve of Neratinib concentration at day 22 following Administration of Neratinib 240 mg in combination with Trastuzumab 2 mg/kg in Subjects with Cancer. | Prior to the first dose, and at hours 1, 2, 4, 6, 8 and 24 on days 22. | |
Secondary | Terminal-phase Elimination Half-life of Neratinib in Combination With Trastuzumab. | Terminal-phase elimination half-life of Neratinib at day 22 following Administration of Neratinib 240 mg in combination with Trastuzumab 2 mg/kg to Subjects with Cancer. | Prior to the first dose, on days 22 through 23 of month 1, and on day 1 in months 2 through 6 |
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