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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03944434
Recruitment Status Recruiting
First Posted May 9, 2019
Last update posted June 24, 2019
Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in women or men aged 70 years-old or older, with hormone receptor positive/HER2 negative advanced breast cancer
Elderly patients are generally more susceptible to the side effects of active treatments. Patients entered in clinical trials, especially the elderly, are not completely representative of the "real" population because of selection process. The lack of data collected from a real population turns the indication of treatment a challenging task and expose older patients to a risk of under treatment (fear of excessive toxicity because of the lack of data). With the aim of covering this gap, we are planning to run a phase II trial evaluating the feasibility of delivering the combination of ribociclib plus NSAI as first-line treatment specifically in a population of breast cancer patients aged ≥70 years. Primary endpoint: • The treatment feasibility will be evaluated as the proportion of patients not having experienced disease progression (PD), still on treatment with ribociclib plus NSAI 6 months after the first drug administration Secondary endpoints: - Treatment adherence - Safety and tolerability - Patient reported outcomes (PROs) - Overall response rate (ORR) - Progression free survival (PFS)
|Experimental: single arm
patients will receive anastrozole tablets (1 mg once daily) or letrozole tablets (2.5 mg once daily) + ribociclib tablets (600 mg day 1 to 21 in a 28 day cycle). Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, physician's decision, patient's refusal/consent withdrawal, or lost to follow-up. A LHRH agonist (triptorelin 3,75 mg or leuprolide 3,75 mg or goserelin 3,6 mg, as injectable intramuscular (i.m.) or subcutaneous (s.c.) implant every 28 days) will be used in men.
ribociclib 600 mg/day orally
Drug: Aromatase Inhibitors, non steroideal
letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally
Drug: LHRH agonist
Triptorelin 3,75 mg or Leuprolide 3,75 mg or goserelin 3,6 mg, as injectable.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Patients male or female, aged 70 years-old or older at the time of informed consent.
2. Patients with advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy.
3. Measurable or not measurable but evaluable disease according to RECIST criteria 1.1
4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen
receptor positive and/or progesterone receptor positive breast cancer by local
5. Patient has a HER2 negative breast cancer defined as a negative in situ hybridization
test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization
(FISH, CISH, or SISH) test is required by local laboratory testing.
6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. Patient has an estimated life expectancy of > 24 weeks.
8. Patient has adequate bone marrow and organ function as defined by all of the following
laboratory values (as assessed by local laboratory):
1. Absolute neutrophil count ≥1.5 x 109/L
2. Platelets ≥ 100 x 109/L
3. Hemoglobin ≥ 9.0 g/dL
4. Potassium, sodium, calcium corrected for serum albumin and magnesium within
normal limits or corrected to within normal limits with supplements before first
dose of the study medication
5. INR ≤ 1.5
6. Serum creatinine <1.5 mg/dl or creatinine clearance ≥50mL/min 7. Total bilirubin < ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN. 8. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be < 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN. 9. Patient must have a 12-lead ECG values with all of the following parameters at screening: 1. QTcF interval at screening 160 or <90 mmHg 12. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug: 1. Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummeloes, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5, 2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. 13. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. NOTE: - The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
Contact: Donata Cavaciocchi, MS +390574802531 firstname.lastname@example.org
Contact: Emanuela Risi, MD +390574802522 email@example.com
Italy, Please Select:
Hospital of Prato
Fondazione Sandro Pitigliani
Principal Investigator: Laura Biganzoli, MD Hospital of Prato
Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.
Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Diéras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936.
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Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155. Erratum in: Ann Oncol. 2019 Nov 1;30(11):1842. Ann Oncol. 2019 Nov;30(11):1842.
Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.
Sonke GS, Hart LL, Campone M, Erdkamp F, Janni W, Verma S, Villanueva C, Jakobsen E, Alba E, Wist E, Favret AM, Bachelot T, Hegg R, Wheatley-Price P, Souami F, Sutradhar S, Miller M, Germa C, Burris HA. Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Feb;167(3):659-669. doi: 10.1007/s10549-017-4523-y. Epub 2017 Oct 22.