A Study of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer

A Randomized, Open-Label, Two-Arm Study of Neratinib (HKI-272) Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000942

Enrollment

480

Registered

2009-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer

Interventions

Intervention1: Neratinib + Paclitaxel : Neratinib - 240 mg orally daily, administered once daily Paclitaxel - 80mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle Treatment will be administe

Eligibility

Inclusion criteria

Inclusion criteria: 1. ErbB-2 positive locally recurrent or metastatic breast cancer 2. Eastern Cooperative Oncology Group (ECOG) 0-2 3. Measurable disease 4. Availability of tumor tissue for HER2 status confirmation (there is no upper age limit for inclusion criteria for this trial)

Exclusion criteria

Exclusion criteria: 1. Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease 2. Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting 3. Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy 4. history of heart disease 5. history of gastrointestinal disease

Design outcomes

Primary

Measure	Time frame
Progression -Free SurvivalTimepoint: 31 Months	—

Secondary

Measure	Time frame
2. Objective Response RateTimepoint: 31 months;3. Duration of ResponseTimepoint: 31 months;4. Clinical Benefit RateTimepoint: 31 months;5. Incidence of Adverse Events between treatment armsTimepoint: 31 months;6. Patient Reported Breast Specific Quality of LifeTimepoint: 31 months;7. Frequency of symptomatic or progressive CNS lesionsTimepoint: 31 months;8. Time to symptomatic or progressive CNS lesionsTimepoint: 31 months;Overall SurvialTimepoint: 43 months	—

Measure

Time frame

2. Objective Response RateTimepoint: 31 months;3. Duration of ResponseTimepoint: 31 months;4. Clinical Benefit RateTimepoint: 31 months;5. Incidence of Adverse Events between treatment armsTimepoint: 31 months;6. Patient Reported Breast Specific Quality of LifeTimepoint: 31 months;7. Frequency of symptomatic or progressive CNS lesionsTimepoint: 31 months;8. Time to symptomatic or progressive CNS lesionsTimepoint: 31 months;Overall SurvialTimepoint: 43 months

—

Countries

Australia, Bahamas, Belarus, Belgium, Bulgaria, Canada, China, Croatia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Malta, Poland, Portugal, Republic of Korea, Romania, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactSwapnali Raut

Representing Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.)

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026