Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Estrogen Receptor (ER)-Negative and Progesterone Receptor (PR)-Negative Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease
18 Years
N/A
Female
Breast Cancer
Trial Information
Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Estrogen Receptor (ER)-Negative and Progesterone Receptor (PR)-Negative Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease
OBJECTIVES:
- Evaluate the clinical safety and toxicity of raloxifene in combination with exemestane
in postmenopausal women with a history of stage 0 (ductal carcinoma in situ), I, II, or
III breast cancer who have no clinical evidence of disease after completion of all
planned adjuvant therapy.
- Evaluate the effects of this combination on plasma concentrations of estrogens, markers
of bone turnover and bone mineral density, serum lipoprotein profile, and quality of
life in this patient population.
- Determine the pharmacokinetics and the pharmacodynamics of this combination in these
patients.
- Determine the feasibility of using mammography and breast MRI to assess the effects of
this drug combination on radiographic breast density.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral raloxifene once a day for 2 weeks.
- Arm II: Patients receive oral exemestane once a day for 2 weeks. After 2 weeks of
single agent therapy, all patients receive combination therapy with oral raloxifene and
oral exemestane once a day for 1 year in the absence of unacceptable toxicity or
disease recurrence. At the end of 1 year, patients may continue receiving raloxifene
alone or raloxifene plus exemestane for a maximum duration of 5 years.
Quality of life is assessed at baseline, and then at 3, 6, and 12 months. Patients who
continue treatment after 1 year have quality of life assessed at 24, 36, 48, and 60 months.
Patients are followed every 3 months for the first year. Patients who continue treatment
after 1 year are followed every 6 months through the fifth year.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Stage 0 (ductal carcinoma in situ), I, II, or III breast cancer with no clinical
evidence of disease after completion of all planned adjuvant therapy
- No prior antiestrogen therapy as adjuvant therapy
- Histologically confirmed history of breast cancer
- CEA and CA15-3 normal
- No prior bilateral mastectomy
- Hormone receptor status:
- Progesterone and estrogen receptor negative OR
- Progesterone and/or estrogen receptor positive
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Menopausal status:
- Postmenopausal, as defined by 1 of the following:
- No spontaneous menses for at least 5 years
- If prior hysterectomy, but have intact ovaries, must have luteinizing
hormone (LH) and follicle stimulating hormone (FSH) levels within
postmenopausal range
- Spontaneous menses within the past 5 years, but amenorrheic (e.g., spontaneous
or secondary to chemotherapy, radiotherapy, or hysterectomy) for at least 12
months, and LH and FSH levels within postmenopausal range
- Bilateral oophorectomy
Sex:
- Female
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No unstable angina
- No New York Heart Association class III or IV heart disease
- No history of venous thrombosis
Pulmonary:
- No history of pulmonary embolism
Other:
- No prior ovarian or endometrial cancer
- No prior or concurrent osteoporosis, as defined by lumbar spine bone mineral density
less than 2.5 SD below the mean value for normal premenopausal women
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy for breast cancer
Endocrine therapy:
- See Disease Characteristics
- At least 3 months since prior hormonal therapy
- At least 3 months since prior calcitonin
- No adjuvant tamoxifen
Radiotherapy:
- At least 4 weeks since prior radiotherapy for breast cancer
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery for breast cancer
- More than 2 years since prior initial surgery
Other:
- At least 3 months since prior bisphosphonates
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Prevention
Principal Investigator
Maura N. Dickler, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067493
NCT ID:
NCT00004247
Start Date:
April 1999
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- breast cancer in situ
- recurrent breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- ductal breast carcinoma in situ
- Breast Neoplasms
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
