Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus
      combination chemotherapy in premenopausal or perimenopausal patients with advanced or
      metastatic breast cancer
    

Detailed description: 
      A phase II randomized study of the combination of Ribociclib plus goserelin acetate with
      Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal
      patients with hormone receptor-positive/ HER2-negative inoperable locally advanced or
      metastatic breast cancer - RIGHT Choice Study
    

Intervention name(s): Docetaxel / Capecitabine; Capecitabine / Vinorelbine; Paclitaxel / Gemcitabine; Ribociclib; Letrozole OR Anastrozole; Goserelin
Intervention type(s): Combination Product; Combination Product; Combination Product; Drug; Drug; Drug
Intervention description(s): Docetaxel (IV Infusion) / Capecitabine (Tablets for oral use):
Docetaxel once, on day 1 of the 3-weeks cycle. Capecitabine twice daily, on Days 1 to 14, followed by a 1-week rest period, in 3 weeks cycle.
Docetaxel (60 - 75 mg/m²)/capecitabine (1600 - 2500 mg/m²/day); Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ).
Capecitabine twice daily on day 1 to 14, followed by a 1-week rest period, in 3 weeks cycle.
Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles.
Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2/day [oral] or (25 to 30 mg/m2 [IV infusion]; Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion):
Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles.
Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles.
Paclitaxel (175 mg/m2) (on Day 1 in 3-weeks cycles)/ gemcitabine (1000 - 1250 mg/m2)
OR
Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2); Dose: 600 mg (200 mg * 3) Days 1 to 21 of each 28 day cycle Tablets for oral use; Letrozole:
Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use
Anastrozole:
dose: 1 mg All days of every cycle without interruption. Tablets for oral use
The NSAI (letrozole or anastrozole) will be decided by the treating physician.; Dose: 3.6 mg Day 1 of each 28 day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
Subcutaneous implant
Other intervention name(s): Combination chemotherapy group.; The chemotherapy regimen will be decided by the treating physician.; Combination chemotherapy group.; The chemotherapy regimen will be decided by the treating physician.; Combination chemotherapy group.; The chemotherapy regimen will be decided by the treating physician.; Endocrine treatment arm:; NSAI + goserelin+ ribociclib; Endocrine treatment arm:; NSAI + goserelin+ ribociclib; Endocrine treatment arm:; NSAI + goserelin+ ribociclib
Intervention MeSH terms: Paclitaxel; Vinorelbine; Docetaxel; Gemcitabine; Capecitabine; Letrozole; Anastrozole; Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, phase II, open label, multi-center trial comparing the combination of NSAI (letrozole or anastrozole) + goserelin + ribociclib versus combination chemotherapy (either of docetaxel/capecitabine or paclitaxel/gemcitabine or capecitabine/vinorelbine). Premenopausal or perimenopausal women with HR+, HER2- negative, advanced breast cancer with ECOG performance status of 0 to 2 and having symptomatic visceral metastases, or rapid progression of disease or impending visceral compromise, or markedly symptomatic non visceral disease will be considered for this study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HR-positive; HER2-negative; advanced breast cancer; Ribociclib; NSAI; Goserelin; Docetaxel / capecitabine; Paclitaxel/gemcitabine; Capecitabine/vinorelbine; CDK4/6 inhibitors; Phase II; ER-positive; PR-positive; Premenopausal; Perimenopausal