Exemestane and Raloxifene in Treating Postmenopausal Women With a History of Ductal Carcinoma in Situ, Stage I, Stage II, or Stage III Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: exemestane (Drug); raloxifene (Drug); adjuvant therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Maura N. Dickler, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.
Chemoprevention therapy is the use of certain drugs to try to prevent the development or
recurrence of cancer. Raloxifene may be effective in preventing the recurrence of breast
cancer.
PURPOSE: Randomized phase II trial to evaluate the effectiveness of exemestane and raloxifene
in treating postmenopausal women who have a history of ductal carcinoma in situ, stage I,
stage II, or stage III breast cancer.
Clinical Details
Official title: 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
Study design: Prevention, Randomized, Active Control
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1999
Last updated: May 23, 2008
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