Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01873833 · ClinicalTrials.gov registry record · Phase 2
Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01873833: Clinical Trial Phase 2 study, sponsored by University of Southern California.
NCT01873833 is a Phase 2 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01873833, a Phase 2 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine and cyclophosphamide daily may kill more tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab together may be an effective treatment for breast cancer.
Primary Outcome
PFS was defined as duration of time from the first dose of study drug to the first documentation of Progressive Disease (PD) by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: \>=20% increase (\>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it
Interventions
- OTHER laboratory biomarker analysis
- DRUG cyclophosphamide
- DRUG capecitabine
- BIOLOGICAL trastuzumab
- DRUG lapatinib ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-07-29 |
| Est. Completion | 2021-03-02 |
| Phase | Phase 2 |
Why NCT01873833 stopped before completion
NCT01873833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01873833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01873833 about?
NCT01873833 is a clinical study titled "Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer". This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine and cyclophosphamide, work in ...
What is the current status of trial NCT01873833?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2013-07-29. Estimated completion is 2021-03-02.
What interventions are being tested in trial NCT01873833?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cyclophosphamide (DRUG), capecitabine (DRUG), trastuzumab (BIOLOGICAL), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT01873833?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01873833's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
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