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Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy


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

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Trial Information

Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy


OBJECTIVES:

Primary

- Determine the 12-month change in breast density in postmenopausal women with ductal
carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant
anastrozole.

Secondary

- Determine the change in estrone sulfate levels in patients treated with this drug.

- Correlate the change in breast density with the change in circulating estrone sulfate
levels in patients treated with this drug.

- Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the
relationship between wild-type aromatase enzyme with change in breast density and
change in estrone sulfate levels in patients treated with this drug.

- Determine the 12-month change in bone density, and correlate it with the change in
circulating estrone sulfate levels in patients treated with this drug.

- Correlate the reversal of hypermethylation with change in circulating estrone sulfate
levels and breast density in patients treated with this drug.

OUTLINE: This is a pilot study. Patients are stratified according to concurrent
bisphosphonate use (yes vs no).

Patients receive oral anastrozole once daily for up to 12 months in the absence of disease
progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer meeting 1 of the following criteria:

- Ductal carcinoma in situ (DCIS)

- Invasive carcinoma

- Stage I-III disease

- Must have undergone breast cancer surgery within the past 6 months, including any of
the following:

- Mastectomy or lumpectomy with or without radiation

- Sentinel node and/or axillary node dissection

- Re-excision of lumpectomy margins

- Intact contralateral breast

- No prior radiation therapy or mastectomy

- Prior biopsies allowed

- Hormone receptor status:

- Estrogen and/or progesterone receptor-positive tumor by immunohistochemical
staining

PATIENT CHARACTERISTICS:

Sex

- Female

Menopausal status

- Postmenopausal, defined as 1 of the following:

- At least 60 years of age

- Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry

- Less than 60 years of age, amenorrheic for < 12 months prior to day 1, and
luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within
postmenopausal range

- Less than 60 years of age, without a uterus, and LH and FSH values within
postmenopausal range

- Underwent prior bilateral oophorectomy

- Underwent prior radiation castration AND amenorrheic for ≥ 6 months

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Chemotherapy

- No prior or concurrent adjuvant chemotherapy for breast cancer

Endocrine therapy

- No prior aromatase inhibitor

- At least 6 weeks since prior and no concurrent tamoxifen

- At least 6 weeks since prior and no concurrent hormone replacement therapy

- Concurrent low-dose, local vaginal estrogen in the form of either a conjugated
estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed

- At least 6 weeks since prior and no other concurrent selective estrogen receptor
modulators (e.g., raloxifene)

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

- No contralateral breast implant

Other

- Concurrent bisphosphonates allowed at the discretion of the treating oncologist

- No concurrent consumption of soy supplements

- Concurrent routine dietary consumption of soy-containing foods allowed

- No other concurrent investigational or commercial drugs or therapies for the
treatment of DCIS or invasive breast cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in breast density after 12 months of treatment

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Vered Stearns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

J0365 CDR0000446285

NCT ID:

NCT00244959

Start Date:

January 2004

Completion Date:

November 2011

Related Keywords:

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

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410