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A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting


Phase 2
21 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting


PRIMARY OBJECTIVES:

I. To estimate 2 year progression-free survival in patients with breast cancer more than 1
cm and/or lymph node positive breast cancer treated with weekly Carboplatin/Nab-Paclitaxel
(with trastuzumab in patients with HER2+ disease, and with bevacizumab in HER2-).

II. To measure clinical response rates in patients treated in the neoadjuvant setting.

III. To measure the microscopic pathological response rate of this regimen in patients
treated in the neoadjuvant setting.

IV. To measure the toxicity and delivered dose intensity of this regimen. V. To assess the
association between microscopic pathologic complete response and clinical complete
response at the primary tumor site in these patients.

VI. To measure the outcome of patients treated with doxorubicin and cyclophosphamide with
patients not treated with doxorubicin and cyclophosphamide.

SECONDARY OBJECTIVES:

I. Develop quantitative analysis methods to obtain pre-treatment tumor characteristic
morphological, enhancement kinetic, and Choline metabolic parameters in breast cancer.
Select an optimal set of features using the logistic regression analysis and the Artificial
Neural Network (ANN) to predict pathologic complete remission (pCR) in HER-2 positive and
negative arm.

II. Investigate whether the early response patterns, analyzed using the percent tumor size
changes, or changes in other lesion characteristic parameters, can be used to predict
pathologic complete remission (pCR) in HER-2 positive and negative arm.

III. Investigate whether combining the pre-treatment tumor characteristic parameters, and
the early response pattern during the treatment course, can achieve a higher "area under the
receiver operating characteristic (ROC) curve" (AUC) in prediction of pCR than those based
on pre-treatment MRI characteristics or tumor response patterns alone.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes and carboplatin IV over 60 minutes once weekly for 12 weeks. Patients with
HER2-positive disease receive trastuzumab IV over 30-90 minutes once weekly for 12 weeks and
patients with HER2-negative disease receive bevacizumab IV over 30-90 minutes once every two
weeks for 5 doses. Treatment continues in the absence of disease progression or unacceptable
toxicity. Beginning 21-40 days later, patients undergo surgery.

After completion of study treatment, patients are followed for 5 years.

Inclusion Criteria


Inclusion criteria

- Are between 21 and 90 years old,

- Have large Stage I, II or III breast cancer which is not immediately treatable with
surgery,or with clinically documented enlarged lymph nodes

- Other than having cancer, are in general good health (determined by history, physical
and laboratory assessment),

Exclusion criteria

- Are pregnant,

- Have early stage breast cancer that could potentially be treated with surgery alone,

- Have congestive heart failure,

- Are unwilling to give informed consent.

Exclusion criteria for receiving bevacizumab treatment

- Have renal impairment

- Have hepatic dysfunction

Exclusion criteria for participating in MRI monitoring sub-study

- Implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical
clips (hemostatic clips) or other metallic implants.

- Engaged in occupations or activities which may cause accidental lodging of
ferromagnetic materials, or have imbedded metal fragments from military activities.

- Received orthodontic work involving ferromagnetic materials.

- Claustrophobia (a fear of enclosed spaces).

- Previously had an allergic response to MRI contrast agents (gadolinium).

- Known history of severe renal insufficiency, asthma, allergic conditions, sickle cell
anemia, chronic hemolytic anemia, and gastrointestinal disorders.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

estimate 2yr progression-free survival in pts with breast cancer more than 1 cm &/or lymph node positive breast cancer treated with weekly Carboplatin/Nab-Paclitaxel(with trastuzumab in patients with HER2+ disease,& with bevacizumab in HER2-)

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Rita Mehta, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 07-61

NCT ID:

NCT00618657

Start Date:

February 2008

Completion Date:

August 2015

Related Keywords:

  • Breast Cancer
  • pre-operative
  • neo-adjuvant
  • triple negative
  • HER2 positive
  • hormone receptor positive
  • breast
  • Carboplatin
  • Nab-paclitaxel
  • Trastuzumab
  • Bevacizumab
  • Inflammatory
  • Breast Neoplasms

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868