Breast Cancer Clinical Trial
Official title:
A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop
tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of
tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine
with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with erlotinib
in treating patients who have metastatic breast cancer that has been previously treated with
an anthracycline and/or a taxane.
OBJECTIVES:
- Determine the anti-tumor activity of erlotinib and gemcitabine in patients with
metastatic breast cancer previously treated with anthracycline and/or taxane.
- Determine the adverse event profile of this regimen in these patients.
- Determine whether epidermal growth factor receptor and HER-2 receptor intensity and
serum concentrations have an impact on clinical response in patients treated with this
regimen.
- Determine the impact of genetic differences in proteins involved in drug response
(transport, metabolism, and mechanism of action) on clinical response and adverse
events associated with gemcitabine in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response are followed every 6 weeks for up to 5 years or until
disease progression (PD). Patients discontinuing study therapy for any other reason are
followed every 3 months until PD and then every 6 months for up to 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |