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NCT01273610 · ClinicalTrials.gov registry record · Phase 2
Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer
A Phase 2 study of Breast Neoplasms and HER2/Neu Positive, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 8
- Study locations
NCT01273610: Active Phase 2 study of Breast Neoplasms and HER2/Neu Positive, sponsored by City of Hope Medical Center.
NCT01273610 is a Phase 2 study of Breast Neoplasms and HER2/Neu Positive that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 40 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (93% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01273610, a Phase 2 study of Breast Neoplasms and HER2/Neu Positive, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to lapatinib or trastuzumab.
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 |
What the registry record for NCT01273610 still lists
NCT01273610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (93% lower).
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.
NCT01273610 lists 8 locations in 5 states (California, North Carolina, New York).
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.
What interventions are being tested in trial NCT01273610?
The interventions under investigation include: Trastuzumab (DRUG), laboratory biomarker analysis (OTHER), pharmacological study (OTHER), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT01273610?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
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 NCT01273610's enrollment target sits among peer trials
40 80th of 97 higher than 17 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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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