Breast Neoplasms Clinical Trial
Official title:
A Phase 2, Multi-Center Trial of ZD1839 (IRESSA) in Combination With Docetaxel as First-Line Treatment in Patients With Advanced Breast Cancer
The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839.
Patients with advanced breast cancer continue to have an extremely poor prognosis with an
average life expectancy of approximately 2 years. Novel treatments designed to exploit
biologic properties of the tumor are urgently required as a means to improve the outcome for
the large numbers of patients who relapse after receiving optimal chemotherapy treatments.
Overexpresssion of EGFR and/or TGF-alpha is frequent in human breast cancer and has been
correlated in many cases with poor prognostic features. Inhibition of the EGFR pathway has
been proposed as a potential therapeutic modality in advanced breast cancer. The
antiproliferative activity of ZD 1839 in combination with cytotoxic drugs, such as docetaxel
was evaluated in breast cancer cell lines ZR-75-1 and MCF-10A ras that coexpress EGFR and
TGF-alpha. Combination treatment demonstrated dose dependent supra-additive growth
inhibition and markedly enhanced apoptotic cell death.
Although taxanes bind to the microtubular network in cells that is essential for mitotic and
interphase cellular functions, the mechanism by which these agents induce cell death is not
entirely clear. Docetaxel has also shown dose-dependent anti-angiogenic activity. Thus, the
mechanism(s) of anti-tumor activity of docetaxel remain unclear and combinations of signal
transduction pathway inhibition and/or anti-angiogenesis may provide potentiation of
concurrent ZD 1839 and docetaxel therapy.
This phase 2 trial is designed to prospectively investigate the efficacy and safetey of
combination therapy with ZD 1839 and docetaxel in patients with metastatic breast cancer.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
| Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
| Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
| Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
| Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
| Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
| Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03698942 -
Delphinus SoftVue™ ROC Reader Study
|
||
| Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
| Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
| Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
| Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
| Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
| Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
| Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
| Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A |