Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 or disease
Breast CancerCarcinoma of the Breast
Drug: PaclitaxelDrug: Trastuzumab
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.
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 ]
Secondary Outcome Measures :
Describe DFS in patient groups defined by tumor size and hormone receptor status. [ Time Frame: 3 years ]
Evaluate the incidence of grade III/IV cardiac left ventricular dysfunction from adjuvant trastuzumab and paclitaxel [ Time Frame: 3 years ]
Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant paclitaxel [ Time Frame: 3 years ]
Evaluate Topoisomerase II, cMYC, and p53 expression, and correlate with event rate [ Time Frame: 3 years ]
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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).