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A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Carcinoma of the Breast

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Trial Information

A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

- 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.

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

- 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

- Left ventricular ejection fraction of greater than or equal to 50%

- Willingness to discontinue any hormonal agent prior to registration and while on

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Eric Winer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Carcinoma of the Breast
  • node-negative breast cancer
  • HER-2 positive
  • Breast Neoplasms
  • Carcinoma



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