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A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels


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

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Trial Information

A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels


OBJECTIVES:

Primary

- Compare the safety, acceptability, and adherence to letrozole vs placebo in
postmenopausal women at increased risk for the development or recurrence of breast
cancer based on elevated plasma estradiol levels.

- Compare the effects of these regimens on menopausal symptoms (including hot flushes,
weight changes, sexual functioning, and genitourinary effects), blood lipid levels,
markers of bone turnover, and multidimensional quality of life in patients treated with
these regimens.

Secondary

- Determine the effect of letrozole-induced reduction of plasma estradiol levels on
mammographic percent breast density in these patients.

OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study.
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral letrozole once daily for 1 year. Patients may then receive
additional oral letrozole once daily for up to 4 years.

- Arm II: Patients receive oral placebo once daily for 1 year. Patients may then receive
oral letrozole once daily for up to 5 years.

In both arms, treatment continues in the absence of unacceptable toxicity or diagnosis of
invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.

Quality of life is assessed at baseline and then at 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued
for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- At increased risk for the development or recurrence of breast cancer, defined as an
estradiol level ≥ 9 pg/mL

- No evidence of suspicious or malignant disease, based on the following examinations:

- Clinical bilateral breast examination within the past 6 months

- Bilateral* mammogram within 3 months before randomization OR within 30 days
after randomization

- Pelvic exam normal within the past 5 years

- General physical exam within the past 6 months NOTE: *Unilateral mammogram of
the uninvolved breast for patients with prior invasive breast cancer or ductal
carcinoma in situ (DCIS)

- Bone density scan within 2 standard deviations from normal within the past 30 days

- Bone density scan ≥ 2 standard deviations below normal allowed if approved by
the study physician

- At least 1 breast that has not been previously treated with radiotherapy or surgery
(for patients with prior invasive breast cancer or DCIS)

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 35 and over

Sex

- Female

Menopausal status

- Postmenopausal, defined by any of the following criteria:

- At least 12 months without spontaneous menstrual bleeding

- Prior hysterectomy and bilateral salpingo-oophorectomy

- ≥ 55 years of age with a prior hysterectomy with or without oophorectomy

- < 55 years of age with a prior hysterectomy without oophorectomy OR the status
of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the
postmenopausal range

Performance status

- Normal activity must not be restricted for a significant portion of the day

Life expectancy

- At least 10 years

Hematopoietic

- Complete blood count with differential normal

- Prior benign neutropenia allowed provided the granulocyte count is ≥ 1,500/mm^3

Hepatic

- Bilirubin normal

- Alkaline phosphatase normal

- SGOT and SGPT normal

Renal

- Creatinine normal

Cardiovascular

- No uncontrolled cardiovascular disease

Other

- Not pregnant

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

- No osteoporosis

- No hyperlipidemia

- No mental health status resulting in cognitive or emotional impairment that would
preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- More than 30 days since prior AND no concurrent use of any of the following hormonal
agents:

- Estrogen or progesterone replacement therapy

- Oral contraceptives

- Raloxifene or other plasma estrogen receptor modulators (SERMs)

- Androgens (e.g., danazol)

- Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or
leuprolide)

- Prolactin inhibitors (e.g., bromocriptine)

- Antiandrogens (e.g., cyproterone)

- More than 60 days since prior AND no concurrent tamoxifen

- No prior aromatase inhibitors (for patients with prior invasive breast cancer or
DCIS)

- No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other
natural products)

- Dietary soy allowed

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

- No prior bilateral mastectomy

Other

- More than 60 days since prior treatment for invasive breast cancer or DCIS

- More than 30 days since prior bisphosphonates or calcitonin

- No prior or concurrent participation on a treatment study for invasive breast cancer
or DCIS

- No concurrent participation in any other cancer prevention study or osteoporosis
prevention study involving pharmacologic agents

- No concurrent calcitonin

- No concurrent bisphosphonate therapy

- Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density
allowed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety, acceptability, and adherence

Safety Issue:

Yes

Principal Investigator

Judy Garber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000375585

NCT ID:

NCT00090857

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • breast cancer in situ
  • ductal breast carcinoma in situ
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dan L. Duncan Cancer Center at Baylor College of MedicineHouston, Texas  77030