Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer

NCT01207102 | Terminated Phase 2 Results

• 1 other identifier: Pro00019321
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to progression without producing intolerable toxicity.

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; Triple negative

Outcome Measures

Primary Outcomes (1)

• PFS

  The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.

  PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first

Secondary Outcomes (1)

• To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With "Triple Negative" Stage IV Metastatic Breast Cancer

  2 years

Study Arms (1)

Abraxane, Carboplatin

EXPERIMENTAL

Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle

Drug: Abraxane; Drug: Carboplatin

Interventions

Abraxane DRUG

Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days

Also known as: paclitaxel protein-bound particles for injectable suspension

Abraxane, Carboplatin

Carboplatin DRUG

area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days

Also known as: Paraplatin

Abraxane, Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed diagnosis of metastatic (Stage IV) breast cancer;
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST);
• "Triple negative" disease defined as "tumor demonstrating no expression for estrogen, progesterone or HER2 receptors." (No expression is categorized as ≤ 10% of cells staining or Allred ≤ 2);
• Aged 18 years or older;
• Eastern Cooperative Oncology Group (ECOG)ECOG/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;
• No prior chemotherapy for metastatic disease.
• At least 6 months must have elapsed since prior adjuvant chemotherapy.
• Laboratory tests performed within 14 days of study entry showing:
• Granulocytes ≥ 1,500/µL;
• Platelets ≥ 100,000/µL;
• Hemoglobin ≥ 9.0 gm/dL;
• Total bilirubin ≤ institutional upper limit of normal (ULN);
• Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN;
• Alkaline phosphatase ≤ 5 times ULN;
• Estimated creatinine clearance ≥ 60 mL/min.

You may not qualify if:

• Pregnant or breast feeding.
• Prior treatment with Abraxane® or carboplatin.
• Prior chemotherapy for metastatic breast cancer.
• Known hypersensitivity to any component of any study drug.
• Active infection.
• Current neuropathy ≥ grade 2.
• central nervous system (CNS) metastases as determined by head CT with contrast or head MRI.
• Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.
• Uncontrolled serious contraindicated medical condition or illness.

Sponsors & Collaborators

• Duke University: lead
• Celgene Corporation: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Peking University School of Oncology/Beijing Cancer Hospital

Beijing, 100142, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Results Point of Contact

• Title: Dr Kimberly Blackwell
• Organization: Duke University Medical Center

black034@mc.duke.edu

919-6681748

Study Officials

• Kimberly L Blackwell, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 22, 2010
• Study Start: August 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 15, 2014
• Results First Posted: December 15, 2014

Record last verified: 2014-08

Locations

CN (1); US (1)