Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00684983 · ClinicalTrials.gov registry record · Phase 2
Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT00684983: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00684983 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00684983, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
This phase II trial studies capecitabine and lapatinib ditosylate to see how well they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating patients with previously treated HER2-positive stage IIIB-IV breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with cixutumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether capecitabine and lapatinib ditosylate are more effective when given with or without cixutumumab in treating breast cancer that has spread nearby or to other areas of the body.
Primary Outcome
Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.
Interventions
- DRUG Capecitabine
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Cixutumumab
- DRUG Lapatinib Ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2008-07-30 |
| Est. Completion | 2019-10-15 |
| Phase | Phase 2 |
What the finished NCT00684983 record still lists
NCT00684983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 4 interventions - of which Capecitabine is the first listed.
NCT00684983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00684983 about?
NCT00684983 is a clinical study titled "Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer". This phase II trial studies capecitabine and lapatinib ditosylate to see how well they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating patients with previously treated HER2-positive stage IIIB-IV breast cancer. Drugs used in chemotherapy, such as capecitabine, work...
What is the current status of trial NCT00684983?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2008-07-30. Estimated completion is 2019-10-15.
What interventions are being tested in trial NCT00684983?
The interventions under investigation include: Capecitabine (DRUG), Quality-of-Life Assessment (OTHER), Cixutumumab (BIOLOGICAL), Lapatinib Ditosylate (DRUG).
Who is sponsoring clinical trial NCT00684983?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00684983's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI