Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Genentech
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00542451

Purpose

The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.

Condition	Intervention	Phase
Breast Cancer Carcinoma of the Breast	Drug: Paclitaxel Drug: Trastuzumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

Evaluate disease free survival (DFS) rate in patients with node-negative HER2-positive breast cancer with tumors less than or equal to 3cm treated with adjuvant trastuzumab and paclitaxel [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Describe DFS in patient groups defined by tumor size and hormone receptor status. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the incidence of grade III/IV cardiac left ventricular dysfunction from adjuvant trastuzumab and paclitaxel [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant paclitaxel [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Evaluate Topoisomerase II, cMYC, and p53 expression, and correlate with event rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate P13K mutations and PTEN alterations in a subset of patients and correlate events with the presence or absence of these mutations/alterations [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Every week for 12 weeks

Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks

Detailed Description:

Participants will enroll in this study at the time they are starting their adjuvant therapy for breast cancer. Participants will receive chemotherapy with paclitaxel every week for 12 weeks. They will begin to receive trastuzumab at the same time they begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab, they will receive trastuzumab every 3 weeks or weekly for 40 weeks.
Participants will be followed with routine assessments such as physical exam and vital signs every 3 months for the first year, and then every 6 months for years 2-5. Then we would like to keep track of the participants medical condition by calling them on the telephone once per year.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed invasive carcinoma of the breast
Tumors must be less than or equal to 3cm in greatest dimension
Must have node-negative breast cancer according to teh AJCC 7th edition
ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods
HER-2 positive: IHC 3+ or FISH >2
Bilateral breast cancers that individually meet eligibility criteria are allowed
Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides must be sent to DFCI for testing
Less than or equal to 84 days from mastectomy or from axillary dissection or sentinel node biopsy if the patient's most extensive breast surgery was a breast-sparing procedure
All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
18 years of age or older
ECOG Performance Status of 0 or 1
Adequate bone marrow function, hepatic function, and renal function as outlined in protocol
Left ventricular ejection fraction of greater than or equal to 50%
Willingness to discontinue any hormonal agent prior to registration and while on study
Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy
Patients undergoing breast conservation therapy must not have any contraindications to radiation therapy

Exclusion Criteria:

Pregnant or nursing women
Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes
History of prior chemotherapy in past 5 years
History of prior trastuzumab therapy
Active, unresolved infection
Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent
Sensitivity to benzyl alcohol
Grade 2 or greater neuropathy per NCI's CTCAv3.0. (Exception: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair).
Active cardiac disease as outlined in protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542451

Contacts

Contact: Eric Winer, MD

617-632-3800

ewinder@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Eric Winer, MD 617-632-3800 ewiner@partners.org
Principal Investigator: Eric Winer, MD
Beth Israel Deaconess Medical Center	Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Steven Come, MD 617-667-4599 scome@bidmc.harvar.edu
Principal Investigator: Steven Come, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Genentech

Investigators

Principal Investigator:

Eric Winer, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Eric Winer, MD )
Study ID Numbers:	07-199
Study First Received:	October 9, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00542451
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

node-negative breast cancer
HER-2 positive

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Trastuzumab
Breast Neoplasms

Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009