Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer (NCT01199367) | Clinical Trial Compass
TerminatedPhase 1
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer
Stopped: The results of the dose escalation phase did not identify a well-tolerated dose that would permit further study in Phase 2.
United States11 participantsStarted 2010-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histopathologically or cytologically confirmed, advanced or metastatic breast cancer (stage IIIb, IIIc or IV disease) including inflammatory breast cancer or inoperable locally advanced disease.
. Measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
. A life expectancy of \> 3 months for Phase 1 and \> 6 months for Phase 2
. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry in Phase 1 and ≤ 1 in Phase 2;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.
. Adequate hematologic, hepatic and renal function
Exclusion criteria
. Type 1 diabetes or uncontrolled Type 2 diabetes
. Subjects showing clinical evidence or with a history of cataract(s), proliferate retinopathy or significant macular edema
. Subjects with abnormal free T4 values and a history or evidence of thyroid disease
. Subjects who are unable or unwilling to take metformin
. Uncontrolled intercurrent illness
. Known or suspected human immunodeficiency virus (HIV) infection or hepatitis B or C
. Subjects with inflammatory diseases of the gastrointestinal tract
. History of other malignancy. Subjects who have been disease free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;