Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Genentech
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038402

Purpose

The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer.

Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.

Condition	Intervention	Phase
Breast Cancer	Drug: Herceptin Drug: Taxol Drug: Fluorouracil Drug: Cytoxan Drug: Epirubicin	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Fluorouracil Paclitaxel Epirubicin hydrochloride Epirubicin Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To confirm the ability to downstage primary tumors overexpressing the Her2 receptor by the addition of Herceptin to standard chemotherapy in the neoadjuvant setting. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the potential of the addition of Herceptin to increase the possibility of breast conservation. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	164
Study Start Date:	April 2001
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Herceptin + Taxol Followed by FEC	Drug: Herceptin Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses. Drug: Taxol 225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles. Drug: Fluorouracil 500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals. Drug: Cytoxan 500 mg/m^2 on Day 1 of each cycle for 4 cycles. Drug: Epirubicin 75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.

Arms

Assigned Interventions

1: Experimental

Herceptin + Taxol Followed by FEC

Drug: Herceptin

Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.

Drug: Taxol

225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.

Drug: Fluorouracil

500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.

Drug: Cytoxan

500 mg/m^2 on Day 1 of each cycle for 4 cycles.

Drug: Epirubicin

75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast with T2-3 (greater than 2 cm), N0-1, M0 will be eligible. Patients with T1N1 (after histological confirmation of nodal disease) will be eligible for the study.
Histologic confirmation of invasive tumor will be done by core needle biopsy. On the tissue obtained, estrogen and progesterone receptors (ER/PR) as well as Her-2/neu (will be determined by IH and/or FISH) and p53 will be done (for research evaluation). Tumor proliferation rate will be evaluable by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67. Residual tumor tissue will be saved in the tissue bank for further future studies.
All patients who are Her-2/neu positive will be eligible for the study. Her-2/neu positivity for protocol purposes will be determined by IHC and patients with tumors that are 3+ or FISH + will be eligible.
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >1,500/mm3, and platelet count > 100,000 mm3. Patients must have adequate liver function, with a bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine <2.0 mg%.
Patients must have a normal cardiac ejection fraction as determined by baseline echocardiogram. Tape must be saved for review by central cardiologist.
Patients who underwent biopsy outside will be eligible if they had a measurable residual tumor.
Patients with multicentric disease and extensive DCIS will be eligible for study.
Patients with a history of cardiac arrhythmia will be eligible for study after being cleared by cardiology.

Exclusion Criteria:

Patients with T1N0 disease are not eligible for the study.
Those patients with history of other invasive malignancies will be excluded except non-melanoma skin cancer and non-invasive cervical cancer.
Patients with a history of congestive heart failure will be excluded.
Patients who had surgical therapy prior to referral will be ineligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038402

Contacts

Contact: Aman U Buzdar, MD

713-792-2817

Locations

United States, Texas
The University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Deborah Francis, RN 713-792-2817
Contact: Debra Frye, RN 713-792-2817
Principal Investigator: Aman U Buzdar, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech

Investigators

Principal Investigator:

Aman U Buzdar, MD

U.T. M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Aman U. Buzdar, MD/Professor )
Study ID Numbers:	ID99-146
Study First Received:	May 30, 2002
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00038402 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Non-Inflammatory Breast Cancer
Operable Breast Cancer
Herceptin
Taxol
FEC

Fluorouracil
Cyclophosphamide
Epirubicin
Trastuzumab
Paclitaxel
Neosar

Study placed in the following topic categories:

Antimetabolites
Skin Diseases
Immunologic Factors
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Cyclophosphamide
Epirubicin
Immunosuppressive Agents
Anti-Bacterial Agents
Oxymetazoline

Paclitaxel
Phenylephrine
Fluorouracil
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Alkylating Agents
Breast Diseases
Skin Diseases

Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Immunosuppressive Agents
Epirubicin
Pharmacologic Actions
Neoplasms
Paclitaxel
Fluorouracil
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009