Status:
ACTIVE_NOT_RECRUITING
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Inflammatory Breast Cancer
Stage IIA Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE2
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...
Detailed Description
PRIMARY OBJECTIVES: I. To test the hypothesis that carboplatin + nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) therapy will demonstrate a promising neoadjuvant pathologic co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2025
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01525966
Start Date
February 15 2012
End Date
December 8 2025
Last Update
March 3 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope Medical Center
Duarte, California, United States, 91010
2
City of Hope- South Pasadena Cancer Center
South Pasadena, California, United States, 91030