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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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 CenterNew York, New York  10021