Neoadjuvant Treatment of Breast Cancer - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00254592

Purpose

Study Aims

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 GM-CSF (days 5-14) 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).
To measure the microscopic pathological response rate of this regimen.
To measure toxicity and the delivered dose intensity of this regimen.
To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.
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.
To determine whether the patients with a higher percent S100+ have a better clinical, pathological response, DFS, and OS.
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.

Condition	Intervention	Phase
Breast Cancer	Drug: Doxorubicin Drug: Cyclophosphamide Drug: Carboplatin Drug: Nab-paclitaxel Drug: GM-CSF Drug: Trastuzumab Drug: Bevacizumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Carboplatin Paclitaxel Sargramostim Granulocyte-macrophage colony-stimulating factor Bevacizumab Trastuzumab Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide With GMCSF Followed by Weekly Carboplatin/Nab-Paclitaxel Plus or Minus Trastuzumab (Herceptin) and Plus or Minus Bevacizumab (Avastin) in Treatment of Large or Inflammatory Breast Cancer-a Phase II Study

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Overall clinical response to the dose dense regimen. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	43
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles

600 mg/m2 IV once a day every 14 days x 2-4 cycles

AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose

100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose

250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide

4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC dose

10mg/kg q 2 wks

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.
Patients must meet one of the criteria defined below (indicate one):
1. Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed - appropriate candidates for neoadjuvant treatment.
2. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.
Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. All patients must have a MUGA or echocardiogram scan performed within 90 days prior to registration and LVEF% must be greater than the institutional lower limit of normal.
Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an SGOT or SGPT ≤ 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.
Patients must have an ANC of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. These tests must have been performed within 90 days prior to registration.
Patients must have a performance status of 0-2 by Zubrod criteria
Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.
In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254592

Locations

United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Rita Mehta, M.D.

Chao Family Comprehensive Cancer Center

More Information

Responsible Party:	University of California, Irvine Medical Center ( Rita Mehta, M.D. )
Study ID Numbers:	UCI 05-38
Study First Received:	November 15, 2005
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00254592
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Inflammatory
Breast Cancer
Female

Neo-adjuvant
HER2 positive
Hormone receptor

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Carboplatin
Cyclophosphamide
Bevacizumab
Doxorubicin
Naphazoline
Oxymetazoline

Inflammatory breast cancer
Guaifenesin
Paclitaxel
Phenylephrine
Trastuzumab
Phenylpropanolamine
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009