NCT00244959

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

3.7 years

First QC Date

October 25, 2005

Last Update Submit

March 18, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerductal breast carcinoma in situbreast cancer in situ

Outcome Measures

Primary Outcomes (1)

  • Change in breast density after 12 months of treatment

    12 months

Secondary Outcomes (5)

  • Change in hormone levels after 12 months of treatment

    12 months

  • Comparison between change in breast density with change in hormone levels after 12 months of treatment

    12 months

  • Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment

    12 months

  • Comparison between change in bone density with change in hormone levels after 12 months of treatment

    12 months

  • Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment

    12 months

Study Arms (1)

Anastrozole

EXPERIMENTAL

Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer

Drug: anastrozoleProcedure: adjuvant therapy

Interventions

anastrozoleDRUG

1 mg orally daily for 12 months

Also known as: Arimidex
Anastrozole
adjuvant therapyPROCEDURE

treatment received after breast cancer surgery

Anastrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • Prowell TM, Blackford AL, Byrne C, Khouri NF, Dowsett M, Folkerd E, Tarpinian KS, Powers PP, Wright LA, Donehower MG, Jeter SC, Armstrong DK, Emens LA, Fetting JH, Wolff AC, Garrett-Mayer E, Skaar TC, Davidson NE, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res (Phila). 2011 Dec;4(12):1993-2001. doi: 10.1158/1940-6207.CAPR-11-0154. Epub 2011 Sep 1.

    PMID: 21885816RESULT

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

AnastrozoleChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Vered Stearns, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

January 1, 2004

Primary Completion

September 1, 2007

Study Completion

November 1, 2011

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(1)