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• Register: EUCTR
• Last refreshed on: 6 January 2015
• Main ID: EUCTR2011-004744-22-BE
• Date of registration: 27/02/2013
• Prospective Registration: Yes
• Primary sponsor: UNICANCER
• Public title: _
• Scientific title: Adjuvant systemic treatment for oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70 according to Genomic Grade (GG): chemotherapy + endocrine treatment versus endocrine treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) multicentre phase III trial
• Date of first enrolment: 27/05/2013
• Target sample size: 2000
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004744-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium

Contacts

• Name: Christine ORSINI
• Affiliation: UNICANCER

• Name: Christine ORSINI
• Affiliation: UNICANCER

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70
MedDRA version: 17.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Trade Name: DOXORUBICINE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-

Trade Name: DOCETAXEL
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 10-40

Trade Name: ENDOXAN
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50-18-0
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 500-1000

Trade Name: MYOCET
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: DOXORUBICIN HYDROCHLORIDE
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: _

Timepoint(s) of evaluation of this end point: NA

Primary end point(s): Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)
The OS is defined as the interval between the date of randomization and the date of death from any cause.

Main Objective: _

Secondary Outcome(s)

Secondary end point(s): _

Timepoint(s) of evaluation of this end point: NA

Secondary ID(s)

GERICO11/PACS10

Source(s) of Monetary Support

Teva