Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
Public ClinicalTrials.gov record NCT00769470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open Label, Randomized Phase II Trial of Presurgical Treatment With Single-Agent Trastuzumab (H) or Lapatinib (Ty) or the Combination of Trastuzumab and Lapatinib (H+Ty), Followed by Six Cycles of Docetaxel (T) and Carboplatin (C) With Trastuzumab (TCH) or Lapatinib (TCTy) or the Combination of Trastuzumab and Lapatinib (TCHTy) in Patients With HER2/Neu-Amplified Operable Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer. PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
Study identification
- NCT ID
- NCT00769470
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Interventions
- trastuzumab Biological
- carboplatin Drug
- docetaxel Drug
- lapatinib ditosylate Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2009
- Primary completion
- Oct 31, 2013
- Completion
- Not listed
- Last update posted
- Jan 21, 2016
Started 2009
United States locations
- U.S. sites
- 15
- U.S. states
- 5
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Hematology Oncology Medical Group, Incorporated - Alhambra | Alhambra | California | 91801 | — |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309-0633 | — |
| St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center | Fullerton | California | 92835 | — |
| North Valley Hematology-Oncology Medical Group | Northridge | California | 91328 | — |
| Wilshire Oncology Medical Group, Incorporated - Pomona | Pomona | California | 91767-3021 | — |
| Sansum Medical Clinic | Santa Barbara | California | 93105 | — |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | — |
| Santa Barbara Hematology Oncology - Solvang | Solvang | California | 93463 | — |
| Cancer Care Associates Medical Group, Incorporated - Redondo Beach | Torrance | California | 90505 | — |
| Cancer Institute of Florida, PA - Orlando | Orlando | Florida | 32804 | — |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | — |
| Hematology and Oncology Consultants, PA - Orlando | Orlando | Florida | 32804 | — |
| Providence Medical Group | Haute Terre | Indiana | 47802 | — |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | — |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00769470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00769470 live on ClinicalTrials.gov.