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Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab


OBJECTIVES:

Primary

- To determine the percentage of pathological responses in patients with stage II or III
breast cancer treated with neoadjuvant therapy comprising fluorouracil, doxorubicin
hydrochloride, and cyclophosphamide followed by trastuzumab (Herceptin®) and
paclitaxel.

- To compare the disease-free survival of patients treated with adjuvant therapy
comprising trastuzumab versus observation.

Secondary

- To measure the overall survival at 3 years in these patients.

- To measure the cardiac safety profile of these regimens in these patients.

- To measure the percentage of patients that become negative on the fluorescence in situ
hybridization (FISH) test at the end of neoadjuvant therapy.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I :

- Neoadjuvant therapy: Patients receive fluorouracil IV, doxorubicin hydrochloride
IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients
then receive trastuzumab (Herceptin®) IV over 30-90 minutes and paclitaxel IV over
1 hour once a week for 12 weeks.

After completion of neoadjuvant therapy, patients proceed to surgery.

- Surgery: Patients undergo definitive surgery. Some patients may also undergo
radiotherapy*.

NOTE: *Patients with initial tumor > 5 cm, inflammatory breast cancer, or with a skin
condition or final pathological evaluation of metastasis to > 4 nodes or 1-3 nodes with
capsular ruptures or extension to fatty tissues receive adjuvant radiotherapy.

- Adjuvant therapy: Beginning 4 weeks after surgery, patients receive trastuzumab IV over
30-90 minutes on day 1. Treatment repeats every 3 weeks for 13 courses.

- Arm II:

- Neoadjuvant therapy: Patients receive neoadjuvant therapy as in arm I.

- Surgery: Patients undergo definitive surgery. Some patients may also undergo
radiotherapy if clinically indicated.

- Observation: Beginning 4 weeks after surgery, patients undergo observation. In both
arms, patients with estrogen receptor- and/or progesterone receptor-positive disease
also receive anastrozole daily for 5 years. Premenopausal patients with remaining
ovarian function (as confirmed by follicle-stimulating hormone [FSH] and estradiol)
after completion of anastrozole undergo chemical or surgical ovarian ablation.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then once a year thereafter.

PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast cancer by needle biopsy

- Diagnosed within the past 4 weeks

- Clinical stage IIB, IIIA, IIIB, or IIIC disease

- Palpable adenopathies present

- HER2/neu-positive disease, as evidenced by either of the following:

- HER2/neu overexpression (3+) by immunohistochemistry (IHC)

- HER2/neu amplification by fluorescence in situ hybridization (FISH)

- No metastatic disease by chest radiography, hepatic ultrasound, and bone scan
(metastatic bone series if no nuclear medicine is available)

- Hormone receptor status:

- Estrogen receptor and/or progesterone receptor status known

PATIENT CHARACTERISTICS:

- Premenopausal or postmenopausal

- WHO performance status 0-2

- Not pregnant or nursing

- Normal hepatic, renal, and hematological function

- LVEF ≥ 55% by nuclear medicine study or echocardiogram

- No prior history of cancer, except carcinoma in situ of the cervix

- No allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab
(Herceptin®)

PRIOR CONCURRENT THERAPY:

- No prior cancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of pathological responses

Safety Issue:

No

Principal Investigator

Claudia Arce-Salinas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional de Cancerologia, Columbia

Authority:

Unspecified

Study ID:

CDR0000557417

NCT ID:

NCT00533936

Start Date:

September 2006

Completion Date:

Related Keywords:

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

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