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Pilot Trial of Paclitaxel-Herceptin Adjuvant Therapy for Early Stage Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Pilot Trial of Paclitaxel-Herceptin Adjuvant Therapy for Early Stage Breast Cancer


I. Evaluate the safety of paclitaxel plus trastuzumab (Herceptin) followed by adjuvant
chemotherapy in women with node positive stage II or IIIa breast cancer with HER2

II. Evaluate the safety of long term trastuzumab (Herceptin) in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy (none
planned vs planned to breast or chest wall). Patients are randomized to one of two treatment

ARM I: Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab
(Herceptin) IV over 30-90 minutes on day 1. Paclitaxel repeats every 3 weeks for 4 courses
and trastuzumab (Herceptin) repeats weekly for 10 courses. At 3 weeks following paclitaxel
and trastuzumab (Herceptin), patients receive doxorubicin IV and cyclophosphamide IV over 1
hour every 3 weeks for 4 courses. Following chemotherapy, estrogen receptor (ER) positive
and/or progesterone receptor (PR) positive patients receive oral tamoxifen twice daily for 5

ARM II: Patients receive same therapy as in Arm I, except for additional trastuzumab
(Herceptin) IV weekly beginning within 3 weeks following completion of chemotherapy and
local therapy and continuing for 1 year. ER and/or PR positive patients receive tamoxifen as
in Arm I but may be concurrent with trastuzumab (Herceptin). Following completion of
doxorubicin and cyclophosphamide, post lumpectomy and post mastectomy patients may receive
local radiotherapy daily for 5-6 weeks. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study within 1 year.

Inclusion Criteria


- Histologically confirmed stage II or IIIa (T1-T3, N1-N2, M0) adenocarcinoma of the
breast HER2 overexpression (2-3+ by immunochemistry)

- Bilateral breast cancer allowed

- Must have had local breast cancer surgery within past 12 weeks

- Mastectomy or lumpectomy with clear surgical margins AND axillary lymph node
dissection with at least 6 nodes removed

- Hormone receptor status: Not specified


- Age: 18 and over

- Sex: Female

- WBC at least 3,000/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 9 g/dL

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Creatinine no greater than 1.5 times ULN

- LVEF at least 50%

- No history of congestive cardiomyopathy

- No congestive heart failure or myocardial infarction within the past 6 months

- No uncontrolled hypertension

- No uncontrolled arrhythmia within the past 6 months

- No other prior malignancy within the past 5 years except curatively treated basal or
squamous cell skin cancer or carcinoma in situ of the cervix

- No other serious medical illness that would limit survival to less than 2 years

- No psychiatric condition precluding study

- Not pregnant or nursing

- Fertile patients must use effective contraception


- No prior chemotherapy for breast cancer

- No prior hormonal therapy for breast cancer

- At least one year since prior tamoxifen for chemoprevention (e.g., Breast Cancer
Prevention Trial)

- No prior radiotherapy to the breast, chest wall, or regional lymph nodes

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

George W. Sledge, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 1999

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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