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

NCT01525966 | Active Not Recruiting Phase 2 Results DMC

• 2 other identifiers: 11174NCI-2012-00025
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• pCR Rate After Treatment.

  pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38%

  At completion of definitive surgery, up to six months from initial treatment

• Residual Cancer Burden (RCB) by Symmans Criteria.

  Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst.

  At completion of definitive surgery, up to six months post-commencement of study chemotherapy.

Secondary Outcomes (4)

• Adjuvant Radiation

  Up to 6 months

• Scope of Surgery

  Up to 6 months.

• Overall Survival

  Up to three years post-commencement of chemotherapy.

• Progression-free Survival

  Up to three years.

Study Arms (1)

Treatment (carboplatin and nab-paclitaxel)

EXPERIMENTAL

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; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: laboratory biomarker analysis

Interventions

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (carboplatin and nab-paclitaxel)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (carboplatin and nab-paclitaxel)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Given IV

Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel

Treatment (carboplatin and nab-paclitaxel)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope- South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Inflammatory Breast Neoplasms; Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Carboplatin; Taxes; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Yuan Yuan
• Organization: City of Hope Medical Center

Yuyuan@coh.org

626-359-8111

Study Officials

• Joanne Mortimer, MD, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 3, 2012
• Study Start: February 15, 2012
• Primary Completion: January 11, 2019
• Study Completion (Estimated): November 11, 2026
• Last Updated: March 30, 2026
• Results First Posted: March 10, 2023

Record last verified: 2026-03

Locations

US (2)