Loading clinical trials...

COMPLETEDPHASE1

Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer

A Randomized Phase I Trial of Nanoparticle Albumin Bound Paclitaxel (Nab-paclitaxel, Abraxane) With or Without Mifepristone for Advanced Breast Cancer

NCT01493310•University of Chicago

View on ClinicalTrials.gov

Summary

This trial will find the best dose of mifepristone when given together with nab-paclitaxel (Abraxane) based on the side effects of the two drugs in patients with advanced breast cancer. Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with mifepristone until their disease worsens or they experience an unacceptable side effect. This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The study will first test the lowest dose in a small group of patients and if they do not have bad side effects, higher doses will be tested.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have metastatic (stage IV) or unresectable (cannot be removed by surgery) stage III breast cancer
•Patients must have evaluable disease
•Patients may have received adjuvant chemotherapy and up to four prior chemotherapy regimens for metastatic or locally recurrent disease and cannot have received prior nab-paclitaxel or mifepristone therapy for metastatic disease
•Patients who are estrogen receptor (ER)- and/or progesterone receptor (PR)-positive must have developed metastatic disease while on adjuvant hormonal therapy or have progression of disease after at least one hormonal therapy for advanced disease) and may have received unlimited prior hormonal therapies
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \> 60%)
•Absolute neutrophil count \>= 1,500/mL
•Platelets \>= 100,000/mL
•Total bilirubin =\< institutional upper limit of normal (ULN)
•AST (serum glutamic oxaloacetic transaminase \[SGOT\])/ALT (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional ULN
•Creatinine =\< institutional ULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
+4 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Patients may not be receiving any other investigational drugs or treatments
•Patients with known brain metastases are eligible as long as they have completed radiation to the brain and have been off of corticosteroid therapy for at least 4 weeks
•History of allergic reactions to compounds similar to mifepristone or paclitaxel/nab-paclitaxel; patients with a history of mild infusion reactions with paclitaxel who were able to continue to receive paclitaxel with corticosteroid premedications will be eligible to participate, as these cases were likely related to Cremophor and not paclitaxel
•Mifepristone may affect the way the body processes some types of drugs so they cannot be taken while on-study. These include but are not limited to non-steroidal anti-inflammatory drugs (NSAIDs) or warfarin, cyclosporine, certain benzodiazepines. The study doctor will review patient's current medications to determined if any are prohibited from the study.
•Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant women are excluded from this study; breastfeeding should be discontinued if patient wishes to participate in the study
•Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
•No history of long-term or ongoing short term use of corticosteroids is allowed

Locations (2)

University of Chicago

Chicago, Illinois, United States

NorthShore University Health System

Evanston, Illinois, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

May 1, 2018

Completion Date

May 1, 2018

Last Updated

September 12, 2018

Enrollment

ACTUAL participants

Conditions

Male Breast CancerRecurrent Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Interventions

mifepristone

DRUG

placebo

DRUG

nab-paclitaxel

DRUG

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

NCT06324240

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8+25 more

View study

RECRUITINGPHASE2

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

NCT06369285

Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer

Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors

PrefeRences And ChemoTherapy In Breast Cancer patiEnts

Pulsed Electromagnetic Fields for Analgesia Post Mastectomy