HR+ or HR- metastatic adenocarcinoma of the breast with a measurable target (RECIST criteria) in patients aged 70 or over MedDRA version: V5 Level: LLT Classification code 10027475
Conditions
Interventions
Trade Name: TAXOTERE®
Product Name: TAXOTERE®
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Fédération Nationale des Centres de Lutte Contre le Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged = 70. 2. Histologically confirmed breast adenocarcinoma. 3. Metastatic disease measurable by scan or MRI (RECIST criteria). 4. First-line metastatic chemotherapy (only one line of prior metastatic hormone therapy is allowed). Prior (neo)adjuvant chemotherapy for breast cancer is allowed. 5. Prior hormone therapy stopped at least 10 days before patient’s enrolment in the study. 6. Satisfactory autonomy of daily activity: IADL = 4 or ADL = 4. 7. Satisfactory haematological and hepatic function: Hb >10g/dL, neutrophil count > 1.5x109/L, platelets > 100x109/L, transaminases 30 ml/min calculated according to Cokroft's formula. 9. Signed informed consent. 10. Life expectancy > 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. All patients that do not fulfil the inclusion criteria. 2. Other serious illness or medical conditions, including: - Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from trial entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias - History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent - Active uncontrolled infection - Active peptic ulcer, uncontrolled diabetes mellitus, inflammatory bowel disease 3. Concurrent treatment with any other anti-cancer therapy: trastuzumab, other chemotherapy or hormone therapy. Bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed. 4. Patients having a history of treatment by trastuzumab. 5. Patients having a history of treatment by taxanes (docetaxel or paclitaxel) within the two (2) years from trial entry. 6. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< ou = 20 mg methylprednisolone per day or equivalent). 7. Definite contraindications for the use of corticosteroids. 8. Past or current history of neoplasm other than breast carcinoma, except: - Curatively treated non-melanoma skin cancer - in situ carcinoma of the cervix - Other cancer curatively treated and with no evidence of disease for at least 5 years 9. Patients having a GDS (geriatric depression scale) score = 12. 10. History of hypersensitivity to docetaxel or drugs formulated in polysorbate 80. 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up; Incapacity for undergoing regular checks. 12. Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry. 13. Male subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of chemotherapy on autonomy of activity in instrumental life, defined according to the IADL index in 8 items during treatment (2nd, 4th and 6th cycle), at 6 and 12 months.;Secondary Objective: To assess: - Response rate according to RECIST criteria after first line docetaxel administered bi-weekly, - Overall survival, progression-free survival, - Impact of chemotherapy on autonomy of activity in instrumental life, defined according to ADL index using 6 items, - Impact of chemotherapy on mood status according to the Geriatric Depression Scale, - Toxicity defined according to the NCI-CTC criteria. Proteomics : Patients will be asked to consent to blood sampling for a proteomic study that will evaluate the ability of specific proteomic profiles to predict for response to treatment and toxicities. A pharmacokinetic study of docetaxel and its metabolites will be offered to every patient during the first cycle. ;Primary end point(s): To assess : - the percentage of patients that maintain their autonomy in all instrumental activities of daily living as defined in the IADL assessment scale, in 8 items during treatment (2nd, 4th and 6th cycle), at 6 and 12 months. - the response rate according to RECIST criteria after first line docetaxel administered bi-weekly | — |
Countries
United Kingdom
Outcome results
None listed