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• Conditions: oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70; MedDRA version: 17.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004744-22-BE
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-27
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

1) Women aged = 70 yo,
2) Histologically proven invasive breast cancer (regardless of the type),
3) Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection,
4) Any N status (pN+ or pN0),
5) No clinically or radiologically detectable metastases (M0),
6) Oestrogen receptor (ER)-positive, as defined by a = 10% tumor stained cells by immunohistochemistry (IHC),
7) HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),
8) Normal haematological function prior to GG evaluation: ANC = 1,500/mm3; platelets count = 100,000/mm3; haemoglobin > 9 g/dl,
9) Normal hepatic function prior to GG evaluation: total bilirubin = 1.25 ULN; ASAT and ALAT = 1.5 ULN; alkaline phosphatases = 3 ULN,
10) Creatinine clearance prior to GG evaluation (MDRD formula) = 40 mL/min,
11) PS (ECOG) = 2,
12) Patient able to comply with the protocol,
13) Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection,
14) Patients must be affiliated to a Social Health Insurance.
Of note:
- there will be no high selection according to previous medical history in order to capture the
whole population and to be able to depict heterogeneity of ageing from 70;
- controlateral breast cancer, invasive BC after ductal carcinoma in situ or isolated local invasive relapse when a question of adjuvant systemic treatment is raised are all eligible cases;
- patients with multifocal or bilateral disease are eligible and followed in the study according to worst GG.
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 2000

Exclusion Criteria

1) Any metastatic impairment,
2) Any tumor = T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
3) ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),
4) HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive,
5) Any chemotherapy, hormonal therapy or radiotherapy for the current breast cancer before surgery,
6) PS (ECOG) = 3,
7) Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),
8) Patient deprived of freedom or under tutelage,
9) Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified