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Breast CancerPhase 2NCT00244959

Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer

A Phase 2 study testing anastrozole and adjuvant therapy in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
anastrozole and adjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Jan 2004to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions
Breast Cancer
Keywords
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
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anastrozoleDrug

    Also called Arimidex

    1 mg orally daily for 12 months

  • adjuvant therapyProcedure or surgery

    treatment received after breast cancer surgery

Study groups in NCT00244959
Study groupRoleWhat they receive
AnastrozoleExperimentalAnastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
Receives: Drug: anastrozole; Procedure: adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in breast density after 12 months of treatment

    Measured: 12 months

Secondary outcomes (5)

  1. Change in hormone levels after 12 months of treatment

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionSep 2007
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244959
Sponsor's protocol ID
J0365 CDR0000446285
Other IDs
P30CA006973, JHOC-J0365, JHOC-SKCCC-J0365
Status last verified
Mar 2013
First submitted
25 Oct 2005
Last updated
19 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21885816

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anastrozole and adjuvant therapy in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in breast density after 12 months of treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00244959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.

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