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A randomized double-blind placebo-controlled trial of Neratinib (HKI-272) after trastuzumab in women with early-stage HER-2/neu overexpressed/amplified breast cancer

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF NERATINIB (HKI-272) AFTER TRASTUZUMAB IN WOMEN WITH EARLY-STAGE HER-2/NEU OVEREXPRESSED/AMPLIFIED BREAST CANCER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-008-10
Enrollment
100
Registered
2010-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Approximately 3850 eligible subjects will be randomly assigned in a 1:1 ratio to 1 of the following 2 arms: • Neratinib daily for 1 year • Placebo daily for 1 year After discontinuing study t
nodal status (0 vs 1-3 vs 4 or more)
and trastuzumab given sequentially versus concurrently with chemotherapy.

Sponsors

PUMA BIOTECHNOLOGY INC.,
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

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 pCR.

Exclusion criteria

Exclusion criteria: • Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. • History of heart disease. • QTc interval > 0.45 seconds • History of gastrointestinal disease with diarrhea as the major symptom.

Contacts

Public ContactJudith Marlene Verastegui

PAREXEL INTERNATIONAL (PERU) S.A.

verastm@wyeth.com2112646 - 989026046

Outcome results

None listed

Source: REPEC (via WHO ICTRP)