Breast cancer: MONALEESA-2 trial

Abbreviations

No EU-CTR

  • MONALEESA-2 references
    2022-03-10
    Gabriel N. Hortobagyi
    Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Investigated (inv)
Comparator (comp)

RIBO+letr

PLB+letr

334

334

Phase:

3

Randomisation:

Double blind

Primary tumour:

Breast

Subtype (biomarker):

HER2 neg., HR poz.

Stage:

meta

Line of therapy:

L1

Primary
RIBO+letr
PLB+letr
HR
p
OS
63.9 mo
51.4 mo
0.76 (0.63-0.93)
0.008
PFS
25.3 mo
16.0 mo
0.57 (0.46-0.70)
<0.001
Secondaries
RIBO+letr
PLB+letr
HR
p
Chemo free survival
39.9 mo
30.1 mo
0.74 (0.62-0.89)
Time to 1st chemo
50.6 mo
38.9 mo
0.74 (0.61-0.91)
(all grades, %)
RIBO+letr
PLB+letr
p
Neutropenia
65.3%
5.5%
NA
Nausea
55.1%
32.1%
NA
Fatigue
43.1%
35.5%
NA
Diarrhea
40.7%
26.4%
NA
Alopecia
35.3%
16.7%
NA
Vomiting
35.0%
19.1%
NA
Constipation
29.9%
22.4%
NA
AST increased
20.4%
6.4%
NA
Rash
20.4%
9.7%
NA
ALT increased
20.1%
7.0%
NA
  • Inclusion
  • Exclusion

- Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. - Patient is postmenopausal. Postmenopausal status is defined either by: • Prior bilateral oophorectomy • Age ≥60 • Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial. - No prior systemic anti-cancer therapy for advanced disease. - Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor posit

- Patient who received any CDK4/6 inhibitor. - Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer Note: • Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization. • Patients who received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible. • Any prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 half-lives or 7 days, whichever is longer, before randomization - Patient is concurrently using other anti-cancer therapy. - Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or

Characteristics
RIBO+letr
PLB+letr
Ad-hoc:
no.pts inv.
no.pts comp.
RIBO+letr
PLB+letr
HR
p
  • OS
  • PFS
analisys of OS
RIBO+letr
PLB+letr
HR (95% CI)
Age (n)
<65 yr (373)
59.7 mo
46.7 mo
0.69 (0.53–0.90)
≥65 yr (295)
68.0 mo
60.4 mo
0.87 (0.64–1.17)
Previous chemotherapy (n)
No (377)
69.5 mo
58.5 mo
0.78 (0.59–1.03)
Yes (291)
52.0 mo
44.7 mo
0.74 (0.56–0.98)
Previous hormonal agent (n)
None (320)
68.9 mo
52.8 mo
0.69 (0.52–0.94)
Tamoxifen (295)
56.5 mo
50.1 mo
0.86 (0.64–1.15)
No. of sites of metastasis (n)
<3 (442)
68.0 mo
56.1 mo
0.78 (0.61–1.00)
≥3 (226)
55.5 mo
46.5 mo
0.71 (0.51–0.98)
Liver involvement (n)
No (537)
68.0 mo
56.9 mo
0.77 (0.62–0.97)
Yes (131)
37.0 mo
38.1 mo
0.81 (0.54–1.24)
Lung involvement (n)
No (366)
66.1 mo
50.5 mo
0.72 (0.55–0.94)
Yes (302)
59.7 mo
52.1 mo
0.81 (0.61–1.09)
Bone lesion only (n)
No (520)
61.5 mo
50.3 mo
0.77 (0.61–0.96)
Yes (148)
72.6 mo
56.4 mo
0.78 (0.50–1.21)
analisys of PFS
RIBO+letr
PLB+letr
HR (95% CI)