Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
Condition: Breast Cancer; Carcinoma of the Breast
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel; Trastuzumab
Intervention description: Every week for 12 weeks; Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
Intervention MeSH terms: Paclitaxel; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: node-negative breast cancer; HER-2 positive

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.
    

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.