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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: neratinib; Other: placebo

• Registration Number: NCT00878709
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Study Start: 2009-07-09
• Disposition First Submitted: 2013-11-12
• Disposition First Submitted QC: 2013-11-12
• Disposition First Posted: 2013-12-05
• Primary Completion: 2014-08-21
• Results First Submitted: 2017-08-10
• Results First Submitted QC: 2017-10-06
• Results First Posted: 2017-10-09
• Study Completion: 2019-10-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2840

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neratinib	neratinib	240 mg orally daily for one year
Placebo	placebo	orally daily for one year

Primary Outcome Measures

Name	Time	Method
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2	From randomization until time of event up to 2 years	Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms	From randomization until time of event up to 2 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Randomization until death due to any cause (up to 119 Months)	OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2	From randomization until time of event up to 2 years	Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms	From randomization until time of event up to 2 years
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2	From randomization until time of event up to 2 years	Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms	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	From randomization until time of event up to 2 years	Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms	From randomization until time of event up to 2 years
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2	From randomization until time of event up to 2 years	CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2	From randomization until time of event up to 2 years	Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).

Trial Locations

Locations (485)

Anniston Oncology; 🇺🇸 Anniston, Alabama, United States

Birmingham Hematology and Oncology Associates, LLC; 🇺🇸 Birmingham, Alabama, United States

Arizona Oncology Associates, PC - HAL; 🇺🇸 Phoenix, Arizona, United States

Arizona Oncology Associates, PC - NAHOA; 🇺🇸 Sedona, Arizona, United States

Arizona Oncology Associates; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Northeast Arkansas Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Cedars-Sinai Medical Group; 🇺🇸 Beverly Hills, California, United States

Ronald Yanagihara, M.D.; 🇺🇸 Gilroy, California, United States

Glendale Adventist Medical Center Cancer Services; 🇺🇸 Glendale, California, United States

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