Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Phase 2

Completed

• Conditions: Advanced Breast Cancer; Breast Cancer
• Interventions: Drug: Neratinib; Drug: Lapatinib; Drug: Capecitabine

• Registration Number: NCT00777101
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Study Start: 2009-02-04
• Primary Completion: 2011-03
• Disposition First Submitted: 2012-04-17
• Disposition First Submitted QC: 2012-04-17
• Disposition First Posted: 2012-04-19
• Results First Submitted: 2017-08-10
• Results First Submitted QC: 2017-10-06
• Results First Posted: 2017-11-09
• Study Completion: 2018-06-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 233

Inclusion Criteria

• Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
• Prior use of Herceptin (trastuzumab), and a taxane
• Adequate cardiac and renal function

Exclusion Criteria

• More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
• Bone as the only site of disease
• Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
• Significant gastrointestinal disorder with diarrhea as major symptom

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neratinib	Neratinib	-
Lapatinib plus Capecitabine	Lapatinib	-
Lapatinib plus Capecitabine	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	From randomization date to progression or death, assessed up to 69 months	Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From randomization date to death, assessed up to 69 months	Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.
Clinical Benefit Rate	From randomization date to progression or last tumor assessment, assessed up to 69 months	Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.; Clinical Benefit (CB) = CR + PR + SD \>= 24 weeks.
Frequency of CNS Metastases (Frequency)	From randomization date to first CNS symptom or lesions	The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.
Objective Response Rate (ORR).	From randomization date to progression or last tumor assessment, assessed up to 69 months	Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study 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.
Duration of Response	From start date of response to first PD, assessed up to 69 months after the first subject was randomized.	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 of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time to CNS Metastases	From randomization date to first CNS symptom or lesions	Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).

Trial Locations

Locations (152)

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

Southwest Cancer Care; 🇺🇸 Murrieta, California, United States

UC Irvine Medical Center; 🇺🇸 Orange, California, United States

Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center; 🇺🇸 Palm Springs, California, United States

Redwood Regional Medical Group, Inc.; 🇺🇸 Santa Rosa, California, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

Hematology Oncology Associates, P.C.; 🇺🇸 Stamford, Connecticut, United States

Palm Beach Institute of Hematology & Oncology; 🇺🇸 Boynton Beach, Florida, United States

Robert R. Carroll, MD, PA; 🇺🇸 Gainesville, Florida, United States

University of Florida; 🇺🇸 Jacksonville, Florida, United States

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