Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised oestrogen receptor positive ductal carcinoma in situ of the breast on adjuvant endocrine therapy

Completed

• Conditions: Ductal carcinoma in situ; Cancer

• Registration Number: ISRCTN22614215
• Lead Sponsor: Sponsor not defined - Record supplied by Institute of Cancer Research (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

1. Unifocal DCIS without an invasive component. Patients with microinvasion (defined as one or more foci of invasion each less than 1 mm) may be included
2. Complete microscopic excision with a MINIMUM radial margin of 1 mm
3. ER positive or progesterone receptor (PgR) positive (either more than 10% tumour cells staining for receptor or a cut point of more than two)
4. Maximum microscopic tumour diameter must be less than 30 mm (less than 15 mm if grade III)
5. Primary surgery within six months of randomisation
6. The majority of women will be postmenopausal and all should be between the ages of 50 and 75 years. Postmenopausal status is defined as meeting one or more of the following criteria:
6.1. Aged over 60
6.2. Bilateral oophorectomy
6.3. Aged under 60 with a uterus and amenorrhoea for at least 12 months
6.4. Aged under 60 without a uterus and with follicle-stimulating hormone (FSH) more than 20 IU/L
6.5. Off Hormone Replacement Therapy (HRT) for more than four weeks and with an FSH more than 20 IU/L. Premenopausal and perimenopausal women (over 50 years of age) are eligible for DCIS II but not for IBIS II study
7. Fully informed signed consent
8. Patient available for long-term follow up

All post-menopausal women will potentially be eligible for IBIS II.

Exclusion Criteria

1. Aged under 50 years
2. ER negative DCIS or PgR negative (less than 10% cell staining positive immunohistochemically or a cutpoint of less than two)
3. Any previous cancer in the past five years (except non-melanoma skin cancer or in situ cancer of the cervix)
4. Current treatment with anti-coagulants
5. Previous deep vein thrombosis or pulmonary embolus
6. Previous tamoxifen or raloxifene use for more than three months
7. Any woman with unexplained postmenopausal bleeding
8. Tumour incompletely excised
9. DCIS lesions equals 30 mm maximum microscopic diameter (more than 15 mm if grade III)
10. Patient treated by mastectomy
11. Patients unable to undergo follow-up
12. Any condition precluding full dose radiotherapy to the breast

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing a recurrence in the affected breast five years after primary surgery.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration.