Breast Cancer Clinical Trial
Official title:
A Phase II Randomized Study of Paclitaxel Versus Paclitaxel + PSC833 for Advanced Breast Cancer (Recurring Less Than 6 Months Since Adjuvant or as Second Line for Advanced Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel with or
without PSC 833 in treating patients with metastatic breast cancer.
OBJECTIVES: I. Evaluate the response rate and time to treatment failure of paclitaxel with
and without the P-glycoprotein (Pgp) antagonist PSC 833 in advanced breast cancer. II. For
each treatment arm, relate paclitaxel AUC (area under curve), and/or time above .05 um/L, to
myelosuppression and/or response. III. To obtain preliminary estimates of MDR in this group
of patients by measuring MDR1-Pgp immunostaining in pretreatment biopsies in 20 patients and
biopsies taken at the time of progression.
OUTLINE: This is a randomized study. Patients are stratified according to three criteria: 1)
treatment within 2 years of adjuvant chemotherapy vs. progression on chemotherapy for
advanced disease 2) measurable vs. evaluable disease 3) institution. Patients receive
paclitaxel alone or paclitaxel plus PSC 833. In the first arm, paclitaxel alone is
administered by continuous infusion over 3 hours once every 3 weeks. In the second arm, PSC
833 is administered PO four times a day for 3 days; paclitaxel is administered by continuous
infusion over 3 hours on day 2. Courses repeat every 3 weeks.
PROJECTED ACCRUAL: Approximately 70 patients will be accrued per year in this study.
;
Allocation: Randomized, 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 | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| 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 |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |