Table 1

Data measures and schedule of data collection

VisitsInclusionFollow-up after M0
Visit at M0
3–6 months after treatment
Visit at M12Via telephone at M24Visit at M36Visit at M60
Inclusion/non-inclusion criteriax
Signed informed consentx
Inclusionx
Clinical examination
Patient medical historyx
Clinical examinationxxxxX
Size, weight, performance statusxxxxx
Vital signsxxxxx
Toxicity evaluationxxxx
Concomitant treatmentsxxxxx
Blood tests
Complete blood countxxxx
Hepatic function/ionogramxxxx
Glycaemia/creatinaemia/lipid panelxxxx
25-hydroxycholecalciferol D3/troponine/brain natriuretic peptidexxxx
FSH, LH, oestradiolaemia*xxx
Paraclinical examination
Osteodensitometry‡x‡x‡x‡
Left ventricular ejection fraction§xxx
Questionnaires 
Quality of lifeHADS, LOT, BDI-SF, QLQC30-BR23
FA13/12, SF12, GPAQ16
HADS, IOCv2
QLQC30-BR23, FA13/12, GPAQ16
HADS, IOCv2
QLQC30-BR23, FA13/12, GPAQ16, SF12
HADS, QLQC30-BR23, FA13/12, GPAQ16
IOCv2, SF12
HADS, IOCv2
QLQC30-BR23, FA13/12, GPAQ16, SF12
Questionnaires social impact/economySocial situationSocial impactProfessional impact¶Social impactSocial impact
Patient follow-up bookletxxxxx
Biological sample collection
Mandatory blood samplexxx
  • *To be performed in non-menopausal patients.

  • †Mandatory examinations to be performed in case of clinical signs of chronic toxicity: echography or myocardial scintigraphy in case of dyspnoea or other signs indicating the possibility of cardiac impairment, ECG in case of palpitations, pelvic echography and if needed hysteroscopy in case of metrorrhagia.

  • ‡For postmenopausal patients at diagnosis and regardless of the hormone receptor positivity status at M0.

  • §In case of treatment with antiaromatase agents, for the visits at 3 years and 5 years. Mandatory examination: at inclusion and at M0, in case of treatment with antracyclines/trastuzumab/radiotherapy to the left breast and/or IMC. During follow-up: examination to be prescribed according to the good clinical practices. In case of treatment with trastuzumab, echography or myocardial scintigraphy every 3 months for 1 year, and thereafter at 5 years if no anomaly. In case of treatment with anthracyclines, radiotherapy to the left breast and/or IMC: echography or myocardial scintigraphy at 5 years.

  • ¶ Questionnaires on professional impact, only for patients with professional activity at M12.

  • BDI, Beck Depression Inventory; EORTC-QLQ, European Organization for Research and Treatment-Quality of Life Questionnaire; FSH, follicle stimulating hormone; GPAQ, Global Physical Activity Questionnaire; HADS, Hospital Anxiety and Depression Scale; IMC, intramammary chain; IOCv2, Impact of Cancer Questionnaire; LH, luteinizing hormone; LOT-R, Life Orientation Questionnaire de Scheier et Carver Revised; M0, month 0 of surveillance, 3–6 after treatment completion; M12, month 12 of surveillance, 12 months after M0; M36, month 36 of surveillance, 36 months after M0; M60, month 60 of surveillance, 60 months after M0; SF-12, 12-Item Short Form Survey.