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NCT00721630 · ClinicalTrials.gov registry record · Phase 2
Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT00721630: Completed Phase 2 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00721630 is a Phase 2 study of Breast Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 24 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00721630, a Phase 2 study of Breast Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
Study Summary
HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you are one of these people, your breast cancer is called "HER2-positive." The HER2 protein is involved in the growth of your breast cancer. Certain drugs can interfere with the ability of the HER2 protein to cause breast cancer growth. Trastuzumab is one of these drugs. You must have already received trastuzumab as treatment for your breast cancer to be considered for this study. Other drugs are being studied in women with HER2-positive breast cancer. Lapatinib (Tykerb™) blocks signals that stimulate HER2-positive breast cancers to grow. The FDA approved lapatinib for use with capecitabine (Xeloda™) in patients who have metastatic breast cancer that has grown or spread after treatment with trastuzumab. Capecitabine was approved by the FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days. Then, patients do not take the pill for seven days. With this schedule and dose, some patients have had side effects that interfered with their comfort. We have used mathematical models to recommend a new schedule of capecitabine. In animals, 7 days of treatment with capecitabine followed by a 7-day break was safer and more active against breast cancer. The purpose of this study is to find out what effect (both good and bad) capecitabine has on you and your breast cancer when given in this new schedule and combined with lapatinib.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- DRUG capecitabine, lapatinib
Study Locations (5)
New York
- Memorial Sloan-Kettering Cancer Center at Commack - Commack
- Memorial Sloan-Kettering Cancer Center - New York
- Memorial Sloan-Kettering Cancer Center at Mercy Medical Center - Rockville Centre
- Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center - Sleepy Hollow
New Jersey
- Memorial Sloan-Kettering at Basking Ridge - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-07 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT00721630 record still lists
NCT00721630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which capecitabine, lapatinib is the first listed.
NCT00721630 lists 5 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00721630 about?
NCT00721630 is a clinical study titled "Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer". HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you are one of these people, your breast cancer is called "HER2-positive." The HER2 protein is involved in the growth of your breast cancer. Certain drugs can interfere with the ability of the HER2 protein to c...
What is the current status of trial NCT00721630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2008-07. Estimated completion is 2016-07.
What conditions does trial NCT00721630 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00721630?
The interventions under investigation include: capecitabine, lapatinib (DRUG).
Who is sponsoring clinical trial NCT00721630?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00721630 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00721630's enrollment target sits among peer trials
24 1042nd of 1224 higher than 170 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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