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Proffered paper session - Breast cancer, metastatic

4241 - Ribociclib (RIB) + tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC): MONALEESA-7 patient-reported outcomes (PROs)


20 Oct 2018


Proffered paper session - Breast cancer, metastatic


Cytotoxic Therapy

Tumour Site

Breast Cancer


Nadia Harbeck


Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272


N. Harbeck1, R. Villanueva2, F. Franke3, G. Babu4, P. Wheatley-Price5, Y. Im6, K. Altundag7, B. Lanoue8, J. Alam8, D. Chandiwana8, M. Colleoni9

Author affiliations

  • 1 Breast Center, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 2 Hospital De Sant Joan Despí Moisès Broggi, Institut Català d'Oncologia, Barcelona/ES
  • 3 Cacon, Hospital de Caridade de Ijuí, Ijuí/BR
  • 4 Kidwai Memorial Institute Of Oncology, HCG Curie Centre of Oncology, Bangalore/IN
  • 5 University Of Ottawa, University of Ottawa, Ottowa/CA
  • 6 Sungkyunkwan University School Of Medicine, Samsung Medical Center, Seoul/KR
  • 7 Department Of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara/TR
  • 8 Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 9 Division Of Medical Senology, Istituto Europeo di Oncologia, Milan/IT


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Abstract 4241


In the Phase III MONALEESA-7 trial (NCT02278120), RIB + TAM/NSAI + goserelin (GOS) significantly improved progression-free survival vs placebo (PBO) + TAM/NSAI + GOS in premenopausal pts with HR+, HER2– ABC; here we report key PRO data.


Pre/perimenopausal pts (N = 672; ≤1 line of prior chemotherapy and no prior endocrine therapy for ABC) were randomized 1:1 to RIB (600 mg/day; 3 weeks on/1 week off) or PBO + TAM (20 mg/day) or an NSAI (letrozole [2.5 mg/day]/anastrozole [1 mg/day]) + GOS (3.6 mg every 28 days). Primary endpoint: PFS. PROs were a secondary endpoint and were evaluated using EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L, and WPAI-GH questionnaires. Changes from baseline and time to 10% deterioration (TTD) in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively.


Questionnaire compliance was high (>75%). On-treatment HRQoL (EORTC QLQ-C30 global health status/QoL score) was maintained up to Cycle (C) 17 in both arms. From C18 onwards, HRQoL improved in the RIB arm (clinically meaningful improvements [>5 points] at C5 and from C19 to C31), but numerically worsened in the PBO arm. Median TTD in HRQoL was not reached (NR) in the RIB arm (95% CI 22.2–NR) vs 21.2 months in the PBO arm (95% CI 15.4–23.0; hazard ratio 0.699; 95% CI 0.533–0.916; p = 0.004). EORTC QLQ-C30 physical, social, and role functioning domains, and WPAI-GH % work time missed were maintained in the RIB arm; physical and role functioning were maintained for a longer duration in the RIB vs PBO arm. WPAI-GH % activity impairment was maintained in the RIB vs PBO arm. Reductions in EORTC QLQ-C30 pain score were observed up to C28 in the RIB arm and up to C17 in the PBO arm; clinically meaningful reductions were observed in the RIB arm from C3 to C11 and C22 to C28.


RIB + TAM/NSAI + GOS improves HRQoL and maintains functioning, work productivity, and activity in premenopausal pts with HR+, HER2– ABC. RIB + TAM/NSAI + GOS is also associated with a clinically meaningful reduction in pain vs PBO + TAM/NSAI + GOS.

Clinical trial identification

NCT02278120, 29 October 2014.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.


Novartis Pharmaceuticals Corporation.

Editorial Acknowledgement

Bhavika Modasia PhD of ArticulateScience Ltd.


N. Harbeck: Personal fees for lectures/consulting: Eli-Lilly, Novartis, Pfizer, during the conduct of the study. P. Wheatley-Price: Personal fees for advisory boards: Novartis, AstraZeneca, Lilly Oncology, Bristol-Myers Squibb, Merck, Takeda, during the conduct of the study. B. Lanoue: Employed by Novartis Pharmaceuticals Corporation, during the conduct of the study. J. Alam: Employment: Novartis. D. Chandiwana: Employment and stock ownership: Novartis. M. Colleoni: Fees for advisory boards: AstraZeneca, Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, and Celldex; Honoraria: Novartis, outside the submitted work. All other authors have declared no conflicts of interest.

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