Breast CancerPhase 2NCT00002934
Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
A Phase 2 study testing long-term screening in people with Breast Cancer, run by Eastern Cooperative Oncology Group at 30 sites in 2 countries.
Trial summary
RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer. PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- long-term screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 25 Jun 1997to Oct 2012
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of the breast
- No greater than 2.5 cm in the greatest dimension
- OR
- Histologically proven high-grade DCIS of the breast
- No greater than 1 cm in greatest dimension
- Region of DCIS must be at least 2.5 mm in greatest dimension (mammographic estimate of size allowed where pathologic measurement is impossible)
- DCIS must be non-palpable; detected by a mammogram or found incidentally by a breast biopsy
- Pathologically confirmed negative margins of at least 3 mm
- Breast must be suitable for breast conserving therapy
- Proper tumor size versus breast size
- No carcinoma or suspicious mammogram findings in other breast sites
- No prior in situ or invasive breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Greater than 5 years
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- Not specified
Other:
- No other invasive malignancies within the past 10 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- No known HIV infection
- No Paget's nipple disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Adjuvant tamoxifen allowed
Radiotherapy:
- No prior radiotherapy to breast
- No adjuvant radiotherapy
Surgery:
- Not specified
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
New England Medical Center Hospital
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
CCOP - Evanston
Evanston, Illinois, 60201
CCOP - Green Bay
Green Bay, Wisconsin, 54301
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
CCOP - Wichita
Wichita, Kansas, 67214-3882
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: Local Excision Alone for Selected Patients With DCIS of the Breast
RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer.
PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.
Read the detailed description
OBJECTIVES:
- Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ (DCIS) prognosis.
- Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS.
- Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation.
- Evaluate patterns of salvage of recurrence and rates of breast conservation.
- Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision.
OUTLINE: This is a registration study stratified by histologic grade (high vs low or intermediate) and adjuvant tamoxifen therapy (yes vs no).
Patients receive standard clinical and mammographic follow-up for greater than 10 years. If recurrence occurs, treatment will be at the discretion of the investigators. Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision.
A follow up magnification view mammogram must be taken after the last local excision, and microcalcification must be negative.
Patients are followed every 6 months for the first 10 years, and then annually thereafter.
PROJECTED ACCRUAL: 1000 (500 per stratum) eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year.
- Conditions
- Breast Cancer
- Being tested
- long-term screening
- Keywords
- breast cancer in situ, ductal breast carcinoma
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-term screeningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pathology Review, Observation and Follow-up | No intervention | Pathology review, observation and follow-up Receives: Procedure: long-term screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actuarial local recurrence rate
Rate of in situ or invasive local breast cancer recurrence
Measured: Assessed at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study start25 Jun 1997
- Primary completionDec 2007
- Study completionOct 2012
Why it stopped: This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorie L. Hughes, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002934
- Sponsor's protocol ID
- CDR0000065370
- Other IDs
- U10CA021115, E-5194
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hughes LL, Wang M, Page DL, Gray R, Solin LJ, Davidson NE, Lowen MA, Ingle JN, Recht A, Wood WC. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Nov 10;27(32):5319-24. doi: 10.1200/JCO.2009.21.8560. Epub 2009 Oct 13.
PubMed 19826126Hughes L, Wang M, Page D, et al.: Five year results of intergroup study E5194: local excision alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-29, S15, 2006.
Solin LJ, Gray R, Hughes LL, Wood WC, Lowen MA, Badve SS, Baehner FL, Ingle JN, Perez EA, Recht A, Sparano JA, Davidson NE. Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study. J Clin Oncol. 2015 Nov 20;33(33):3938-44. doi: 10.1200/JCO.2015.60.8588. Epub 2015 Sep 14.
PubMed 26371148
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Excision Alone for Selected Patients With DCIS of the Breast
- ClinicalTrials.gov ID
- NCT00002934
- Acronym / sponsor ID
- CDR0000065370
- Conditions
- Breast Cancer
- Keywords
- breast cancer in situ, ductal breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jun 1997 (actual)
- Primary completion
- Dec 2007 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer.
PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.
Detailed description
OBJECTIVES:
- Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ (DCIS) prognosis.
- Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS.
- Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation.
- Evaluate patterns of salvage of recurrence and rates of breast conservation.
- Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision.
OUTLINE: This is a registration study stratified by histologic grade (high vs low or intermediate) and adjuvant tamoxifen therapy (yes vs no).
Patients receive standard clinical and mammographic follow-up for greater than 10 years. If recurrence occurs, treatment will be at the discretion of the investigators. Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision.
A follow up magnification view mammogram must be taken after the last local excision, and microcalcification must be negative.
Patients are followed every 6 months for the first 10 years, and then annually thereafter.
PROJECTED ACCRUAL: 1000 (500 per stratum) eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathology Review, Observation and Follow-up | No intervention | Procedure: long-term screeningPathology review, observation and follow-up |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long-term screening | Procedure or surgery | Pathology Review, Observation and Follow-up |
Primary outcome
Actuarial local recurrence rate
Time frame: Assessed at 5 years
Rate of in situ or invasive local breast cancer recurrence
Results and safety
The study was stopped early (reason given: This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 19826126Hughes LL, Wang M, Page DL, Gray R, Solin LJ, Davidson NE, Lowen MA, Ingle JN, Recht A, Wood WC. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Nov 10;27(32):5319-24. doi: 10.1200/JCO.2009.21.8560. Epub 2009 Oct 13.
- Results publicationHughes L, Wang M, Page D, et al.: Five year results of intergroup study E5194: local excision alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-29, S15, 2006.
- Derived from this study: PubMed 26371148Solin LJ, Gray R, Hughes LL, Wood WC, Lowen MA, Badve SS, Baehner FL, Ingle JN, Perez EA, Recht A, Sparano JA, Davidson NE. Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study. J Clin Oncol. 2015 Nov 20;33(33):3938-44. doi: 10.1200/JCO.2015.60.8588. Epub 2015 Sep 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorie L. Hughes, MD study chair
Emory University
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing long-term screening in people with Breast Cancer, run by Eastern Cooperative Oncology Group at 30 sites in 2 countries.
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: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, South Africa. 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 was stopped early (reason given: This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.). Results are not available in the source record.
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?
Actuarial local recurrence rate (time frame: Assessed at 5 years). 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 NCT00002934, which also lists 3 linked publications.
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 22 Jun 2023.