Clinical trial NCT00077168: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
breast cancer in situ
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-02-11
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local tumor control (invasive and in situ local recurrence)
Secondary outcomes:
measure: Mastectomy rate
measure: Pattern of relapse in the breast
measure: Contralateral primary
measure: Breast cancer metastases
measure: Mortality
measure: Quality of life
measure: Molecular markers that predict ipsilateral tumor recurrence
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Frenchay Hospital at North Bristol NHS Trust
state: England
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Broomefield
country: United Kingdom
facility: Broomfield Hospital
state: England
city: Chelmsford
country: United Kingdom
facility: Chelmsford and Essex Centre
state: England
city: Colchester
country: United Kingdom
facility: Essex County Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Derby
country: United Kingdom
facility: Queen's Hospital
state: England
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: England
city: Guildford
country: United Kingdom
facility: St. Luke's Cancer Centre at Royal Surrey County Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Manchester
country: United Kingdom
facility: South Manchester University Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes General Hospital
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Poole Dorset
country: United Kingdom
facility: Poole Hospital NHS Trust
state: England
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: England
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: England
city: Stockton-On-Tees
country: United Kingdom
facility: University Hospital of North Tees
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust - Surrey
state: England
city: Torquay Devon
country: United Kingdom
facility: Torbay Hospital
state: England
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: England
city: Worcester
country: United Kingdom
facility: Worcester Royal Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary at NHS Grampian
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: University of Glasgow
state: Scotland
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
state: Wales
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
Study officials:
affiliation: Institute of Cancer Research, United Kingdom
name: Ronald Kaggwa
References: