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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
233
Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
Progression Free Survival
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.
Time frame: From randomization date to progression or death, assessed up to 69 months
Overall Survival (OS)
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.
Time frame: From randomization date to death, assessed up to 69 months
Objective Response Rate (ORR).
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.
Time frame: From randomization date to progression or last tumor assessment, assessed up to 69 months
Clinical Benefit Rate
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.
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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
...and 142 more locations
Time frame: From randomization date to progression or last tumor assessment, assessed up to 69 months
Duration of Response
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 frame: From start date of response to first PD, assessed up to 69 months after the first subject was randomized.
Frequency of CNS Metastases (Frequency)
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.
Time frame: From randomization date to first CNS symptom or lesions
Time to CNS Metastases
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).
Time frame: From randomization date to first CNS symptom or lesions