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Breast CancerPhase 2NCT00077168

Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole

A Phase 2 study testing anastrozole, tamoxifen citrate and adjuvant therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 29 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ. Read more about this study

Who is it for?
Ages 40 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
anastrozole, tamoxifen citrate and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
2,000 participants
Where
29 sitesUnited Kingdom
Study dates
Apr 2004to Sep 2017
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 40 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component
  • Microinvasion (defined as 1 or more foci of invasion each < 1 mm) allowed
  • Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required
  • Maximum microscopic tumor diameter < 30 mm (< 15 mm if grade 3 tumor)
  • Planning to receive adjuvant tamoxifen or anastrozole for 5 years
  • Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II
  • Hormone receptor status:
  • Estrogen receptor positive OR
  • Progesterone receptor positive
  • More than 10% tumor staining for receptor OR a cutpoint of ≥ 2

PATIENT CHARACTERISTICS:

Sex

  • Female

Menopausal status

  • Premenopausal, perimenopausal, or postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No prior deep vein thrombosis

Pulmonary

  • No prior pulmonary embolus

Other

  • No unexplained postmenopausal bleeding
  • No contraindication to full-dose radiotherapy to the breast
  • No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • No prior tamoxifen or raloxifene use for more than 3 months in duration

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  • No prior mastectomy

Other

  • No concurrent anticoagulants

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United Kingdom29 sites

  • Aberdeen Royal Infirmary at NHS Grampian

    Aberdeen, Scotland, AB25 2ZN

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • Frenchay Hospital at North Bristol NHS Trust

    Bristol, England, BS16 1LE

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Broomfield Hospital

    Broomefield, England, CM1 7ET

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • Chelmsford and Essex Centre

    Chelmsford, England, CM2 0QH

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Queen's Hospital

    Derby, England, DE1 2QY

  • Dorset County Hospital

    Dorchester, England, DT1 2JY

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • University of Glasgow

    Glasgow, Scotland, G11 6NT

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England, GU2 7XX

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Charing Cross Hospital

    London, England, W6 8RF

  • South Manchester University Hospital

    Manchester, England, M23 9LT

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Milton Keynes General Hospital

    Milton Keynes, England, MK6 5LD

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Poole Hospital NHS Trust

    Poole Dorset, England, BH15 2JB

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Scarborough General Hospital

    Scarborough, England, YO12 6QL

  • University Hospital of North Tees

    Stockton-on-Tees, England, TS19 8PE

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Torbay Hospital

    Torquay Devon, England, TQ2 7AA

  • Hillingdon Hospital

    Uxbridge, England, UB8 3NN

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

Other trials in United Kingdom

About this study

Official title: Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.

PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.

Read the detailed description

OBJECTIVES:

Primary

  • Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone.
  • Compare the quality of life of patients treated with these regimens.

Secondary

  • Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens.
  • Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

All patients receive adjuvant tamoxifen or anastrozole for 5 years.

  • Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks.
  • Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 5 years.

Patients are followed every 6 months for 1 year and then annually for up to 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.

Conditions
Breast Cancer
Being tested
anastrozole, tamoxifen citrate, adjuvant therapy, radiation therapy
Keywords
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

  • tamoxifen citrateDrug

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

What is being measured

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

  1. Local tumor control (invasive and in situ local recurrence)

Secondary outcomes (7)

  1. Mastectomy rate

  2. Pattern of relapse in the breast

  3. Contralateral primary

  4. Breast cancer metastases

  5. Mortality

  6. Quality of life

  7. Molecular markers that predict ipsilateral tumor recurrence

Timeline

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

  1. First posted11 Feb 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionSep 2017 (estimated)

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
Randomised
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077168
Sponsor's protocol ID
CDR0000349580
Other IDs
ICR-DCIS-II, EU-20341
Status last verified
Oct 2007
First submitted
10 Feb 2004
Last updated
9 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anastrozole, tamoxifen citrate and adjuvant therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 29 sites in United Kingdom.

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: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United Kingdom. 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?

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?

Local tumor control (invasive and in situ local recurrence). 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 NCT00077168.

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 9 Feb 2009.

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