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

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ClinicalTrials.gov Identifier: NCT01525966
Recruitment Status : Active, not recruiting
First Posted : February 3, 2012
Last Update Posted : July 13, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is inflammatory or has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Condition or disease Intervention/treatment Phase
Inflammatory Breast Cancer Stage IIA Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Triple-negative Breast Cancer Stage IIB Breast Cancer Estrogen Receptor Negative Progesterone Receptor Negative HER2/Neu Negative Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Other: laboratory biomarker analysis Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : February 15, 2012
Actual Primary Completion Date : January 11, 2019
Estimated Study Completion Date : January 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (carboplatin and nab-paclitaxel)
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
  • 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

Primary Outcome Measures :
  1. pCR or Symmans 0-1 pathological response [ Time Frame: At completion of definitive surgery ]
    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 :
  1. Overall survival [ Time Frame: 5 years from completion of study treatment ]
    Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.

  2. Progression-free survival [ Time Frame: 5 years from completion of study treatment ]
    Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.

  3. 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 ]
    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.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 (< 10%) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525966

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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
City of Hope- South Pasadena Cancer Center
South Pasadena, California, United States, 91030
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
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Principal Investigator: Yuan Yuan, MD, PhD City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01525966    
Other Study ID Numbers: 11174
NCI-2012-00025 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action