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Terminated Phase 1 Interventional

Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer

ClinicalTrials.gov ID: NCT01199367

Public ClinicalTrials.gov record NCT01199367. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 3:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination With Lapatinib and Letrozole in Subjects With Advanced or Metastatic Breast Cancer Whose Tumors Overexpress HER2

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

Study identification

NCT ID
NCT01199367
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Kyowa Kirin Co., Ltd.
Industry
Enrollment
11 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2010 (Type not available)
Primary completion
Dec 2012 (Actual)
Completion
Dec 2012 (Actual)
Last update posted
Apr 25, 2024

2010 – 2012

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Breastlink Research Group Long Beach California 90250 —
Associates in Hematology-Oncology Los Angeles California 90057 —
Sylvester Comprehensive Cancer Center Deerfield Beach Florida 33136 —
Clinical Oncology Associates Farmington Hills Michigan 48336 —
MD Anderson Cancer Center Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01199367, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 25, 2024 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01199367 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →