Adjuvant Cytotoxic chemoTherapy In Older wome
- Conditions
- Early stage breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN41708421
- Lead Sponsor
- The Institute of Cancer Research and Imperial College Healthcare NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 1000
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
8.2. Bilirubin within normal range (unless known Gilbert?s disease)
8.3. Alanine aminotranferase (ALT) and aspartate aminotransferase (AST) less than or equal to 1.5 x upper limit of normal (ULN)
8.4. Albumen within normal range
8.5. Creatinine less than or equal to 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula greater than 50 ml/min
9. No active, uncontrolled infection
10. Written informed consent given
11. No previous anthracycline chemotherapy at any time, and no other systemic anti cancer therapy within the last 5 years, unless exposure to treatment is brief, and in the context of a peri-operative trial with biological endpoints
12. No previous mantle radiotherapy
13. Randomisation as soon as reasonably possible after definitive surgery, ideally within 8 weeks
14. Patient available for routine long term hospital follow-up
Initial information at the time of registration:
1. Age 70 years or over
2. Histological diagnosis of invasive breast carcinoma
3. Primary operable breast cancer surgically treated by wide local excision with clear margins (equal to or more than 1 mm) or mastectomy
4. Axillary staging for node negative cases and axillary clearance or radiotherapy for axillary node positive disease
5. ER negative or ER weakly positive e.g. Allred/Quick score less than three or Histo score less than 100
6. Early stage disease with no evidence of metastases clinically or on routine staging investigations
7. Risk factors for relapse suggest risk more than 30% in five years e.g. any of the following:
a. Grade three
b. Node positive
c. More than 2 cm tumours with unknown grade
d. Neuropsychiatric Inventory (NPI) score 4.4 or higher
7. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic and renal function i.e.
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)
2. Locally advanced breast cancer (T4 and/or N3 disease)
3. Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy
4. Patients not able or willing to give informed consent
5. Patients not available for a minimum of five years? follow-up
6. Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV)
7. Patients with significant cardiac disease, such as impaired left ventricular function or active angina (requiring regular anti-anginal medication and/or resulting in restricted physical activity)
8. Patients with a history of significant renal impairment or disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse free interval
- Secondary Outcome Measures
Name Time Method <br> Current information as of 22/01/2009:<br> 1. Disease-free survival (DFS) (for completeness and comparison with other studies)<br> 2. Overall survival (OS)<br> 3. Cause-specific survival<br> 4. Distant disease-free survival (DDFS)<br> 5. Safety and tolerability of chemotherapy (overall and for each schedule)<br> 6. Treatment compliance (overall and for each schedule)<br> 7. Quality of life<br><br> Initial information at the time of registration:<br> 1. Quality of life<br> 2. Disease-free survival (for completeness and comparison with other studies)<br> 3. Cause-specific survival<br> 4. Overall survival<br> 5. Health economic measures<br> 6. Toxicities of chemotherapy<br> 7. Compliance/tolerability of Computer Tomography (CT) (overall and for each schedule)<br>