Breast Cancer Clinical Trial

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

Summary

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.

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Full 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.

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Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

406

Study ID:

NCT00542451

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

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There are 20 Locations for this study

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University of California-San Francisco
San Francisco California, 94115, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Indiana University
Indianapolis Indiana, 46202, United States
John Hopkins University
Baltimore Maryland, 21231, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Dana-Farber at Faulkner Hospital
Boston Massachusetts, 02130, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Cape Cod Healthcare
Hyannis Massachusetts, 02601, United States
Lowell General Hospital
Lowell Massachusetts, 01854, United States
North Shore Medical Center
Peabody Massachusetts, 01960, United States
Washington University
Saint Louis Missouri, 63110, United States
North Shore LIJ Health System Monter Cancer Center
Lake Success New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Weill Cornell Medical College
New York New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Case Western University
Cleveland Ohio, 44195, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
University of Vermont Cancer Center
Burlington Vermont, 05401, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

406

Study ID:

NCT00542451

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

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