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CompletedNCT01493310Updated Sep 12, 2018

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

A Phase 1 interventional study of mifepristone and placebo in Male Breast Cancer, Recurrent Breast Cancer and Stage IIIA Breast Cancer, sponsored by University of Chicago. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-12.

Sponsored by University of Chicago · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 9 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
  • Morning cortisol >= institutional normal
  • Negative serum or urine pregnancy test is required for women of child-bearing potential (able to get pregnant)
  • Women of child-bearing potential and men who are sexually active must agree to use two forms of birth control prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Arm A (hormone therapy, chemotherapy)

    Patients will receive mifepristone and nab-paclitaxel in 28-day treatment cycles. Patients receive mifepristone once a day by mouth on days 0, 1, 7, 8, 14, and 15 and nab-paclitaxel by intravenous infusion (IV) on days 1, 8, and 15. Treatment cycles are repeated every 28 days in the absence of disease progression or unacceptable side effects.

    Drug: mifepristone · Drug: nab-paclitaxel

  • Active comparator
    Arm B (chemotherapy)

    Patients will receive nab-paclitaxel and placebo for a 28-day treatment cycle (Cycle 1). Patients receive placebo once a day by mouth on days 0, 1, 7, 8, 14, and 15 and nab-paclitaxel by intravenous infusion (IV) on days 1, 8, and 15. Patients then cross-over to Arm A after completion of the first treatment cycle.

    Drug: placebo · Drug: nab-paclitaxel

Interventions

  • Drugmifepristone

    Given orally (by mouth) Up to 4 doses of mifepristone will be studied (300 mg, 600 mg, 900 mg, 1200 mg)

    Also known as: Mifegyne, Mifeprex, RU-38486

  • Drugplacebo

    Given orally

    Also known as: PLCB

  • Drugnab-paclitaxel

    Given by intravenous infusion (IV) Dose of 80 mg/m2

    Also known as: ABI-007, nab paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, nanoparticle albumin-bound paclitaxel

06

What researchers measure

Primary outcomes

  1. Determination of the safest dose of mifepristone when given in combination with nab-paclitaxel

    This study will seek the safest dose of mifepristone given in combination with nab-paclitaxel. Safety of each dose will be determined by the number and seriousness of side effects experienced by patients receiving each dose.

    Time frame: 28days (Cycle 1)

07

Study locations

2 sites
  • University of Chicago
    Chicago, Illinois 60637-1470, United States
  • NorthShore University Health System
    Evanston, Illinois 60201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01493310
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Nov 2011
Primary completion
May 2018
Completion
May 2018
Last update
Sep 12, 2018

Study contacts

Rita Nanda
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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