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Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer
NCT01273610 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or tumor cancer-killing substances to them. Giving lapatinib ditosylate together with trastuzumab may kill more tumor cells.
Conditions Studied
Interventions
- DRUG Trastuzumab
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG Lapatinib
Study Locations (8)
California
- City of Hope Medical Center — Duarte
- City of Hope Antelope Valley — Lancaster
- South Pasadena Cancer Center — Pasadena
North Carolina
- Lineberger Comprehensive Cancer Center, University of North Carolina — Chapel Hill
- Duke University Medical Center — Durham
New York
- Roswell Park Cancer Institute — Buffalo
Ohio
- Case Western Reserve University — Cleveland
Pennsylvania
- Thomas Jefferson University — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-04-20 |
| Est. Completion | 2026-05-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01273610
The ClinicalTrials.gov registry entry for NCT01273610 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 771 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01273610 reports 8 study locations spanning 5 distinct geographic areas — top geographies include California, North Carolina, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01273610 about?
NCT01273610 is a clinical study titled "Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer". This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to ot...
What is the current status of trial NCT01273610?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-04-20. Estimated completion is 2026-05-19.
What conditions does trial NCT01273610 study?
This clinical trial studies the following conditions: Breast Neoplasms, HER2/Neu Positive, Geriatric Health Services. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01273610?
The interventions under investigation include: Trastuzumab (DRUG), laboratory biomarker analysis (OTHER), pharmacological study (OTHER), Lapatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01273610?
This trial is sponsored by City of Hope Medical Center, which has 771 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01273610 being conducted?
This trial has 8 study locations across California, New York, North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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