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 (RIGHT Choice)
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|ClinicalTrials.gov Identifier: NCT03839823|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Combination Product: Docetaxel / Capecitabine Combination Product: Capecitabine / Vinorelbine Combination Product: Paclitaxel / Gemcitabine Drug: Ribociclib Drug: Letrozole OR Anastrozole Drug: Goserelin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|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)|
|Official Title:||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|
|Actual Study Start Date :||February 25, 2019|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Comparator arm
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine will be administer to patients enrolled in the control group. The chemotherapy regimen will be decided by the treating physician.
Combination Product: Docetaxel / Capecitabine
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)
Combination Product: Capecitabine / Vinorelbine
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]
Combination Product: Paclitaxel / Gemcitabine
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)
Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2)
Experimental: Ribociclib arm
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
Dose: 600 mg (200 mg * 3) Days 1 to 21 of each 28 day cycle Tablets for oral use
Drug: Letrozole OR Anastrozole
Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use
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.
- Progression Free Survival [ Time Frame: Up to approximately 34 months ]Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.
- Time to treatment failure [ Time Frame: Up to approximately 34 months ]Time to treatment failure is defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, change to other anti-cancer therapy, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'.
- Overall response rate (ORR) [ Time Frame: Up to approximately 34 months ]Overall response rate (ORR) is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR), as per local review and according to RECIST 1.1.
- Clinical benefit rate [ Time Frame: Up to approximately 34 months ]Clinical benefit rate is defined as the proportion of patients with a best overall response of CR, or PR or stable disease, lasting for a duration of at least 24 weeks, as defined by RECIST 1.1.
- Time to response [ Time Frame: Up to approximately 34 months ]Time to response is defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1.
- Overall survival [ Time Frame: Up to approximately 46 months ]Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
- Frequency/severity of adverse events, lab abnormalities. [ Time Frame: Up to approximately 46 months ]Safety of ribociclib in combination with NSAI and goserelin, and combination chemotherapies
- Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire [ Time Frame: Up to approximately 46 months ]
Functional Assessment of Cancer Therapy - Breast (FACT-B) will be collected to assess health-related QoL, health status, functioning, disease symptoms, side effects, and cancer-related pain.
Descriptive statistics will be used to summarize the overall score at each scheduled assessment time point. Additionally, change from baseline at the time of each assessment will be summarized.
The distribution of time to definitive 10% deterioration in the global health status from FACT-B questionnaire will be assessed in the two treatment arms. Scores range from 0 to 4. no subscale. 0 score is the worst for social/family and functional wellbeing and 4 is the worst for physical, emotional wellbeing and additional concerns.
- 3-month treatment failure rate [ Time Frame: Up to approximately 34 months ]Treatment failure rate is defined as the proportion of patients who discontinued the study treatment due to progressive disease, death due to any cause, change to other anti-cancer therapy, or discontinuation due to reasons other than protocol violation or administrative problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839823
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaceuticals|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|