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

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 Paclitaxel Fluorouracil Epirubicin hydrochloride Epirubicin 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, 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

4 mg/kg - 1st dose, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy. Total of 24 doses.

Drug: Taxol

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

Drug: Fluorouracil

500 mg/m^2 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.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Histological confirmation of invasive, but non-inflammatory T2-3 (greater than 2 cm), N0-1, M0 carcinoma of the breast. Patients with T1N1 (after histological confirmation of nodal disease) will be eligible. Patients with T1N0 disease are not eligible.
Her-2/neu positivity of 3+ per IHC and/or positive per FISH.
Signed informed consent.
Negative history of other invasive malignancies other than non-melanoma skin cancer and non-invasive cervical cancer.
Adequate bone marrow function: granulocytes > 1,500/mm3 and platelets >100,000/mm3. Adequate liver and renal function: normal bilirubin and creatinine < 2.0 mg%.
Normal cardiac ejection fraction per echocardiogram.
Negative history for congestive heart failure. If history of cardiac arrhythmia, eligible after cleared by cardiology.
Must have measurable residual tumor post baseline biopsy. Patients with multicentric and/or extensive DCIS are eligible.

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

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

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Aman U. Buzdar, MD/Professor )
Study ID Numbers:	ID99-146
First Received:	May 30, 2002
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00038402
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

Fluorouracil

Cyclophosphamide

Epirubicin

Trastuzumab

Paclitaxel

Neosar

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Cyclophosphamide

Epirubicin

Naphazoline

Oxymetazoline

Paclitaxel

Phenylephrine

Guaifenesin

Fluorouracil

Trastuzumab

Phenylpropanolamine

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Mitosis Modulators

Physiological Effects of Drugs

Antimitotic Agents

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Tubulin Modulators

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Antineoplastic Agents, Phytogenic

Alkylating Agents

ClinicalTrials.gov processed this record on November 20, 2008

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