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

Study Description

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Brief Summary:

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 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	69 participants
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
Study Start Date :	February 15, 2012
Estimated Primary Completion Date :	February 2019
Estimated Study Completion Date :	February 2019

Arms and Interventions

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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; 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

Outcome Measures

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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.

Eligibility Criteria

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Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes 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

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Locations

United States, California
City of Hope Medical Center	Recruiting
Duarte, California, United States, 91010
Contact: Yuan Yuan, MD, PhD 800-826-4673 yuyuan@coh.org
Principal Investigator: Yuan Yuan, MD, PhD
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

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Yuan Yuan, MD, PhD	City of Hope Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT01525966 History of Changes
Other Study ID Numbers:	11174; NCI-2012-00025 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted:	February 3, 2012
Last Update Posted:	May 8, 2018
Last Verified:	May 2018

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Inflammatory Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel	Albumin-Bound Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action