Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00878709
• Date of registration: 08/04/2009
• Prospective Registration: Yes
• Primary sponsor: Puma Biotechnology, Inc.
• Public title: Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer ExteNET
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
• Date of first enrolment: July 9, 2009
• Target sample size: 2840
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00878709
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Bahamas, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Korea, Republic of, Lebanon, Lithuania, Macedonia, The Former Yugoslav Republic of, Malaysia, Malta, Mexico, Netherlands, New Zealand, North Macedonia, Peru, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Development Chief Medical and Scientific Officer
• Affiliation: Puma Biotechnology, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.

- Been treated for early breast cancer with standard of care duration of trastuzumab.

- Could have been treated neoadjuvantly but have not reached pathologic complete
response.

Exclusion Criteria:

- Positive clinical and radiologic assessments for local or regional recurrence of
disease at the time of study entry.

- History of heart disease.

- Corrected QT (QTc) interval >0.45 seconds

- History of gastrointestinal disease with diarrhea as the major symptom.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: neratinib

Other: placebo

Primary Outcome(s)

Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms [Time Frame: From randomization until time of event up to 2 years]

Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 [Time Frame: From randomization until time of event up to 2 years]

Secondary Outcome(s)

Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 [Time Frame: From randomization until time of event up to 2 years]

Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms [Time Frame: From randomization until time of event up to 2 years]

Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms [Time Frame: From randomization until time of event up to 2 years]

Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 [Time Frame: From randomization until time of event up to 2 years]

Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms [Time Frame: From randomization until time of event up to 2 years]

Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 [Time Frame: From randomization until time of event up to 2 years]

Overall Survival (OS) [Time Frame: Randomization until death due to any cause (up to 119 Months)]

Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 [Time Frame: From randomization until time of event up to 2 years]

Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 [Time Frame: From randomization until time of event up to 2 years]

Secondary ID(s)

3144A2-3004 / B1891004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00878709