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

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 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


Study Type:	Interventional
Study Design:	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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Paclitaxel Carboplatin

Genetic and Rare Diseases Information Center resources: Inflammatory Breast Cancer

U.S. FDA Resources

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 ]
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 ]
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 ]
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 ]
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:	69
Study Start Date:	February 2012
Estimated Primary Completion Date:	May 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


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

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

National Cancer Institute (NCI)

Investigators


Principal Investigator:	George Somlo	City of Hope Medical Center

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) )
Study First Received:	January 27, 2012
Last Updated:	January 13, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017