Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

Completed · Phase 2/Phase 3

Conditions studied: Breast Tumor, Breast Cancer, Cancer of the Breast, Estrogen Receptor- Negative Breast Cancer, HER2- Negative Breast Cancer, Progesterone Receptor- Negative Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer, Triple-negative Breast Cancer, Triple-negative Metastatic Breast Cancer, Metastatic Breast Cancer

In brief

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

Key facts

Study ID

NCT01881230

Run by

Celgene

People needed

191

Starts

2013-09-26

Expected to finish

2016-10-28

Last updated by the study team

2019-02-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Male subjects
• Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy \& monoclonal antibody therapy are acceptable.
• Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease
• History of, or known current evidence of brain metastasis, including leptomeningeal involvement.
• Subjects with bone as the only site of metastatic disease
• Subjects with regional lymph node as the only site of metastatic disease
• Serious intercurrent medical or psychiatric illness, including serious active infection
• History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
• History of other primary malignancy in the last 5 years prior to randomization. Subjects with prior breast cancer history are eligible, however, the most recently obtained biopsy must demonstrate triple negative disease (source documented). Subjects with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
• Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies which, in the opinion of the investigator, may lead to serious complications
• Peripheral neuropathy Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
• Subjects who have received an investigational product within the previous 4 weeks prior to randomization
• Subject is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
• Pregnant or nursing women
• Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or any other platin, or nucleoside analogue agents
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
• Any condition that confounds the ability to interpret data from the study
• History of seropositive human immunodeficiency virus (HIV)
• Subjects who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications

Where it is running

• Arizona Center for Cancer Care — Glendale, Arizona, United States
• Arizona Cancer Research Alliance — Scottsdale, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Pacific Cancer Medical Center Inc — Anaheim, California, United States
• California Cancer Associates for Research and Excellence cCARE — Escondido, California, United States
• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• Wilshire Oncology Medical Group, Inc — La Verne, California, United States
• Translational Research Management — Los Angeles, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Redwood Regional Medical Group, INC — Santa Rosa, California, United States
• Center for Hematology-Oncology — Boca Raton, Florida, United States
• Memorial Breast Cancer Center — Hollywood, Florida, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Joliet Oncology-Hematology Associates, Ltd — Joliet, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Investigative Clinical Research of Indiana, LLC — Indianapolis, Indiana, United States
• University of South Alabama Mitchell Cancer Institute — Lafayette, Louisiana, United States
• University of Maryland School of Med — Baltimore, Maryland, United States
• Ironwood Cancer and Research Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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