Neoadjuvant Treatment of Breast Cancer

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT00254592
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doxorubicin — DRUG
    60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles
  • Cyclophosphamide — DRUG
    600 mg/m2 IV once a day every 14 days x 2-4 cycles
  • Carboplatin — DRUG
    AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose
  • Nab-paclitaxel — DRUG
    100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose
  • GM-CSF — DRUG
    250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
  • Trastuzumab — DRUG
    4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
  • Bevacizumab — DRUG
    10mg/kg q 2 wks

Study Details

Study Aims 1. To measure the clinic response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks). 2. To measure the microscopic pathological response rate of this regimen. 3. To measure toxicity and the delivered dose intensity of this regimen. 4. To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients. 5. To determine whether the GM-CSF increases the post treatment dendritic cells (S100+) percentage in the tumor draining lymph node as compared to pretreatment S100+ cells. 6. To determine whether the patients with a higher percent S100+ have a better clinical, pathological response, Disease Free Survival (DFS), and overall Survival (OS). 7. To determine whether flow cytometry of dendritic cells performed post-treatment in blood sample shows an increase in dendritic cell population compared to pretreatment levels.

Key Dates

First listed
Nov 16, 2005
Start date
Oct 31, 2005
Status verified
Feb 2019
Primary completion
Sep 4, 2013
Completion
Sep 4, 2013

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AC with GM-CSF and Carboplatin/Nab-Paclitaxel
    Doxorubicin and cyclophosphamide (AC) administered intravenously every 14 days up to a total of 4 cycles, with GM-CSF on days 4-13, depending on tumor response. Two weeks after the completion of AC, weekly doses of carboplatin/nab-paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. Subjects who receive 4 cycles of AC will receive 9 doses of nab-paclitaxel and subjects who receive 2 cycles of AC will receive 12 weeks of nab-paclitaxel. In addition, subjects will receive trastuzumab weekly (12-16) doses if they are Her-2 positive and bevacizumab (6-8) doses every 2 weeks if they are Her-2 negative. Each clinic visit will last approximately ½ hour.

Primary Outcome Measure

Overall Clinical Response to the Dose Dense Regimen [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Chao Family Comprehensive Cancer Center· Orange, CA

Related Studies