Adjuvant Cytotoxic chemoTherapy In Older wome

The Institute of Cancer Research and Imperial College Healthcare NHS Trust (UK)0 sites1,000 target enrollmentJanuary 20, 2006

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Early stage breast cancer
Sponsor: The Institute of Cancer Research and Imperial College Healthcare NHS Trust (UK)
Enrollment: 1000
Status: Terminated
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

January 20, 2006

End Date

February 1, 2009

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

The Institute of Cancer Research and Imperial College Healthcare NHS Trust (UK)

•Current information as of 22/01/2009:
•1\. Age 70 years or over of either sex
•2\. Performance status 0 or 1
•3\. Histological diagnosis of invasive breast carcinoma
•4\. Primary operable breast cancer surgically treated by wide local excision or mastectomy with clear margins (greater than 1 mm apart from deep margin if full thickness resection)
•5\. Axillary staging performed by sentinel node biopsy, axillary sampling or clearance. All node positive patients must have had axillary clearance or radiotherapy to the axilla
•6\. Early stage disease with no evidence of metastases clinically or on routine staging investigations
•7\. High risk of relapse (approx 30%). This will include any patient with HER2 positive disease, or ER negative disease. High risk ER positive disease would typically be expected to be grade 3 with 4\+ positive nodes. Other ER positive patients may be considered on an individual basis.
•8\. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function, i.e.:
•8\.1\. Haemoglobin (Hb) greater than 9 g/dL; white blood cell count (WBC) greater than 3 × 10^9/L; platelets greater than 100 x 10^9/L

•Current information as of 22/01/2009:
•1\. Previous invasive breast cancer within the last 5 years
•2\. Previous ductal carcinoma in situ (DCIS) within the last 5 years if treated systemically
•3\. Any previous haematological malignancy or melanoma
•4\. Primary inoperable breast cancer (T4 and/or N3 disease)
•5\. Patients who have had breast\-conserving surgery in whom there is a contra\-indication for, or decline of, post\-operative radiotherapy
•6\. Patients with significant cardiac disease as determined by multiple\-gated acquisition scan (MUGA) or ECHO (left ventricular ejection fraction \[LVEF] less than 55% excluded)
•7\. Patients not able or willing to give informed consent
•Initial information at the time of registration:
•1\. Previous invasive breast cancer or bilateral breast cancer (DCIS or lobular carcinoma in situ \[LCIS]. LCIS is allowed)