Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01525966
First received: January 27, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This phase II trial studies how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together before surgery works in treating patients with locally advanced or inflammatory triple negative breast cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Condition Intervention Phase
Inflammatory Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-negative Breast Cancer
Drug: carboplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • pCR or Symmans 0-1 pathological response [ Time Frame: At completion of definitive surgery ] [ Designated as safety issue: No ]
    A two stage design using MD Anderson criteria of lack of evidence of any residual invasive tumor in breast and/or regional lymph node.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years from completion of study treatment ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.

  • Progression-free survival [ Time Frame: 5 years from completion of study treatment ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.

  • Number of patients experiencing serious adverse events (SAEs) graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    SAEs will be characterized by type of adverse event and grade, and by the time of onset in relation to the first day of therapy for each cycle. Attribution of SAEs to treatment (unrelated, unlikely, possible, probable, or definite) will also be reported. The cumulative percentage of patients experiencing treatment-related SAEs and its relationship to treatment duration will also be reported.


Estimated Enrollment: 45
Study Start Date: February 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be diagnosed with locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory triple negative breast cancer
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • Tumor negative for expression of hormone receptors (< 1%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testing
  • Bilirubin =< 1.5 mg/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal
  • Alkaline phosphatase =< 2 x upper limit of normal
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin > 9.0 g/dL
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable
  • Left ventricular ejection fraction > 50%
  • Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
  • Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test screening for patients of childbearing potential
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • No prior therapies are allowed for the treatment of the newly diagnosed breast cancer; patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible, provided that they have not received prior taxanes or carboplatin as part of their prior treatment regimen, and that they meet all eligibility criteria

Exclusion Criteria:

  • Known active hepatitis B or C
  • Known active human immunodeficiency virus (HIV)
  • Prior breast cancer or other invasive malignancy treated within 5 years
  • Pregnancy
  • Neuropathy > grade 1
  • Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/primary investigator (PI)
  • Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
  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: NCT01525966

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: George Somlo, MD    800-826-4673    gsomlo@coh.org   
Principal Investigator: George Somlo, MD         
City of Hope- South Pasadena Cancer Center Recruiting
South Pasadena, California, United States, 91030
Contact: Stephen C. Koehler    626-396-2900    skoehler@coh.org   
Principal Investigator: Stephen C. Koehler, MD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: George Somlo City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01525966     History of Changes
Other Study ID Numbers: 11174, NCI-2012-00025
Study First Received: January 27, 2012
Last Updated: May 21, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammatory Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014