NCT01525966Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 27 Jan 2012
- Start date
- 1 Mar 2012
- Primary completion date
- 11 Jan 2019
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT01525966
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 67
- From 1 Mar 2012 to the primary completion date, 11 Jan 2019
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior breast cancer or other invasive malignancy treated within 5 years
Other illness
- Known active hepatitis B or C
- Known active human immunodeficiency virus (HIV)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| City of Hope- South Pasadena Cancer Center Coordinator of this site? Confirm its status | South Pasadena | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.