Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00915018
• Date of registration: 04/06/2009
• Prospective Registration: Yes
• Primary sponsor: Puma Biotechnology, Inc.
• Public title: Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer NEFERTT
• Scientific title: A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
• Date of first enrolment: August 21, 2009
• Target sample size: 479
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00915018
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Malaysia, Malta, Mexico, Peru, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Puma
• Affiliation: Biotechnology

Key inclusion & exclusion criteria

Inclusion Criteria:

- ErbB-2 positive locally recurrent or metastatic breast cancer

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Measurable disease

- Availability of tumor tissue for HER2 status confirmation

Exclusion Criteria:

- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
or metastatic disease

- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
adjuvant setting

- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
therapy

- History of heart disease

- History of gastrointestinal disease



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

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Neratinib

Drug: Paclitaxel

Drug: Trastuzumab

Primary Outcome(s)

Progression-Free Survival [Time Frame: From randomization to disease progression or death, assessed up to 5.3 years]

Secondary Outcome(s)

Symptomatic or Progressive Central Nervous System (CNS) Lesions [Time Frame: From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years]

Clinical Benefit Rate [Time Frame: From randomization to disease progression or death, assessed up to 5.3 years]

Duration of Response [Time Frame: From first response to first PD or death, assessed up to 5.3 years after first subject randomized]

Objective Response Rate [Time Frame: From randomization to disease progression or last tumor assessment, assessed up to 5.3 years]

Secondary ID(s)

3144A2-3005 / B1891005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00915018