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A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer


OBJECTIVES:

- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval
between biopsy and re-excision alters the expression of tissue biomarkers relative to
placebo controls in postmenopausal women with newly diagnosed breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral
placebo daily.

Upon completion of phase I, all treatment centers begin phase II of the study.

- Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo
daily.

Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy)
in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 and 2 weeks after surgery.

PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for
this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed noninvasive or small invasive breast cancer

- Low or intermediate grade (ductal carcinoma in situ, T1, or T2) OR

- Estrogen and/or progesterone receptor positive

- Largest mass no greater than 5 cm

- Clustered microcalcifications as only abnormality allowed with no upper size
limit

- If no distinction between mass and microcalcifications, size as 1 lesion

- Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study

- No evidence of metastases from any malignancy

- Hormone receptor status:

- Estrogen and progesterone receptor positive (unless low or intermediate grade
tumor)

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Postmenopausal by one of the following:

- Prior oophorectomy

- Over age 50 with prior hysterectomy, ovaries remaining

- Uterus and ovaries intact and no menstrual period for more than 3 months

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10 g/dL

- Absolute granulocyte count greater than 1,000/mm^3

Hepatic:

- Albumin greater than 3 g/dL

- Bilirubin less than 1.5 mg/dL

- AST less than 100 U/L

- Alkaline phosphatase less than 200 U/L

Renal:

- Creatinine less than 1.5 mg/dL

Cardiovascular:

- No history of deep vein thrombosis

Pulmonary:

- No prior pulmonary embolus

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 1 year since prior chemotherapy

Endocrine therapy:

- At least 1 year since prior aromatase inhibitors, antiestrogens, or LH
agonists/antagonists

- No concurrent hormone replacement therapy or oral contraceptives (from time of
randomization)

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- No concurrent treatment for other malignancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Carol J. Fabian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Kansas

Authority:

United States: Federal Government

Study ID:

CDR0000067956

NCT ID:

NCT00005886

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • Breast Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Loyola University Medical CenterMaywood, Illinois  60153
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Comprehensive Cancer Centers of the DesertPalm Springs, California  92262
U.S. Oncology Research Inc.Houston, Texas  77060