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Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer

Phase 2
19 Years
Open (Enrolling)
Inflammatory Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-negative Breast Cancer

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Trial Information

Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer


I. To test the hypothesis that carboplatin + nab-paclitaxel (paclitaxel albumin-stabilized
nanoparticle formulation) therapy will demonstrate a promising neoadjuvant pathologic
complete response (pCR) rate for eligible patients.

II. To test the hypothesis that carboplatin + nab-paclitaxel therapy will demonstrate a
promising Symmans 0-1 pathological response rate for eligible patients.


I To evaluate the overall survival and event-free survival of eligible patients treated with
carboplatin + nab-paclitaxel neoadjuvant chemotherapy.

II. To evaluate the toxicities and tolerance of carboplatin + nab-paclitaxel therapy in this
patient population.

III. To evaluate the role of laboratory correlates in response, toxicity and survival

IV. To procure tissue and perform analysis of gene and protein expression profiles of
pre-treatment primary tumor (estimated success rate: 80%) and residual tumors (25%) and
lymph nodes including the study of tumor niche (50%), studying sequential assessment of
cellular characteristics and gene and protein expression profiles.

V. To identify specific mutations in tumor deoxyribonucleic acid (DNA) in comparison to
adjacent tissue and germ line DNA procured prior to, during, and subsequent to neoadjuvant
chemotherapy, and to detect/measure, as feasible, the presence of such mutations in
fragmented circulating DNA from plasma, and to correlate these mutations with the
presence/characteristics of circulating tumor cells in order to identify prognostic and
predictive indicators of persisting/relapsed disease and targets for therapy.

VI. To assess ribonucleic acid (RNA) (using Mammaprint/Blueprint and 44,000 Agilent platform
gene array), (micro) miRNA and protein profiles in tumor, adjacent tissue and plasma prior
to, during, and at completion of neoadjuvant chemotherapy in order to establish prognostic
and predictive indicators of outcome, markers of persistent/relapsed disease, and targets
for therapy.

VII. To analyze tumor DNA and genomic DNA from plasma by microarray and reverse
transcriptase (RT)-polymerase chain reaction (PCR) analysis to assess copy numbers/single
nucleotide polymorphisms (SNP)/genomic polymorphisms in genes for the purposes of
establishing prognostic and predictive indicators of outcomes; markers of
persistence/relapse disease, drug resistance, and drug metabolism; and targets of therapy.

VIII. To assess the prognostic and predictive value of conventional pathological features
(stage, estrogen and progesterone receptor and human epidermal growth factor receptor
[HER-2] status, presence of lymphovascular invasion, high grade tumor status) in comparison
to such values derived from the molecular approaches.

IX. To procure tumor from the primary and definitive surgical specimen for the purpose of
establishing breast cancer stem cell lines.

X. To procure blood samples for the purpose of identifying and characterizing circulating
tumor cells.


Patients receive carboplatin intravenously (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

After completion of study treatment, patients are followed up every 3 months for 4 years and
then every 6 months for 1 year.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pCR or Symmans 0-1 pathological response

Outcome Description:

A two stage design using MD Anderson criteria of lack of evidence of any residual invasive tumor in breast and/or regional lymph node.

Outcome Time Frame:

At completion of definitive surgery

Safety Issue:


Principal Investigator

George Somlo

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Federal Government

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Inflammatory Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms



City of Hope Medical CenterDuarte, California  91010
City of Hope- South Pasadena Cancer CenterSouth Pasadena, California  91030