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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01493310
First received: December 2, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Drug: mifepristone
Drug: placebo
Drug: nab-paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase I Trial of Nanoparticle Albumin Bound Paclitaxel (Nab-paclitaxel, Abraxane) With or Without Mifepristone for Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Determination of the safest dose of mifepristone when given in combination with nab-paclitaxel [ Time Frame: 28days (Cycle 1) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 32
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Given orally (by mouth)

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

Other Names:
  • Mifegyne
  • Mifeprex
  • RU-38486
Drug: nab-paclitaxel

Given by intravenous infusion (IV)

Dose of 80 mg/m2

Other Names:
  • ABI-007
  • nab paclitaxel
  • paclitaxel albumin-stabilized nanoparticle formulation
  • nanoparticle albumin-bound 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
Given orally
Other Name: PLCB
Drug: nab-paclitaxel

Given by intravenous infusion (IV)

Dose of 80 mg/m2

Other Names:
  • ABI-007
  • nab paclitaxel
  • paclitaxel albumin-stabilized nanoparticle formulation
  • nanoparticle albumin-bound paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493310

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Rita Nanda University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01493310     History of Changes
Other Study ID Numbers: 11-0546, NCI-2011-03525
Study First Received: December 2, 2011
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms, Male
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Mifepristone
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents

ClinicalTrials.gov processed this record on September 22, 2014