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

• Status: Active, not recruiting
• Trial end date: 2022-01-14
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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 (< 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