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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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)

A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

NCT01881230•Celgene

View on ClinicalTrials.gov

Summary

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.

Detailed Description

ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Receptor (ER), Progesterone Receptor (PgR), and human epidermal growth factor receptor 2 (HER2) negative (triple negative) metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer. In the phase 2 portion of the study, the combinations of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus carboplatin will be evaluated, and a comparator arm of gemcitabine combined with carboplatin will be used. In the phase 3 portion of the study, the selected nab-paclitaxel combination treatment will be compared to gemcitabine combined with carboplatin to evaluate progression free survival, safety and tolerability, overall survival, disease control rate and duration of response in women with metastatic triple negative breast cancer. Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female subjects, age ≥ 18 years at the time informed consent is signed
•2. Pathologically confirmed adenocarcinoma of the breast
•3. Pathologically confirmed as triple negative, source documented, defined as both of the following
•1. Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: \< 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)
•2. Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).
•4. Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis
•5. Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy; unless (a) anthracycline treatment was not indicated or was not the best treatment option for the subject in the opinion of the treating physician; and (b) anthracycline treatment remains not indicated or, in the opinion of the treating physician, is not the best treatment option for the subject's metastatic disease.
•a. Newly diagnosed subjects presenting with TNMBC are eligible for the study if anthracycline treatment is not indicated or is not the best treatment option for the subject in the opinion of the treating physician.
•6. Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines
•7. Life expectancy ≥ 16 weeks from randomization
+20 more criteria

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1. Male subjects
•2. Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy \& monoclonal antibody therapy are acceptable.
•3. Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease
•4. History of, or known current evidence of brain metastasis, including leptomeningeal involvement.
•5. Subjects with bone as the only site of metastatic disease
•6. Subjects with regional lymph node as the only site of metastatic disease
•7. Serious intercurrent medical or psychiatric illness, including serious active infection
•8. History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
•9. 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.
+11 more criteria

Locations (140)

Ironwood Cancer and Research Center

Chandler, Arizona, United States

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

Key Dates

Start Date

September 26, 2013

Primary Completion Date

October 28, 2016

Completion Date

October 28, 2016

Last Updated

February 21, 2019

Enrollment

191

ACTUAL participants

Conditions

Breast TumorBreast CancerCancer of the BreastEstrogen Receptor- Negative Breast CancerHER2- Negative Breast CancerProgesterone Receptor- Negative Breast CancerRecurrent Breast CancerStage IV Breast CancerTriple-negative Breast CancerTriple-negative Metastatic Breast CancerMetastatic Breast Cancer

Interventions

nab-Paclitaxel

DRUG

Carboplatin

DRUG

Gemcitabine

DRUG

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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: February 21, 2019Data 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

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)

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer