Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line (RIBBIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03462251|
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : July 3, 2019
This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab in patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis.
Half of the patients will receive a combination of ribociclib and AI/fulvestrant while the other half will receive capecitabine + bevacizumab or paclitaxel +/- bevacizumab.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hormone Receptor Positive Tumor HER 2 Negative Breast Cancer||Combination Product: Ribociclib and aromatase inhibitor or fulvestrant Combination Product: Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab||Phase 3|
This is a prospective, randomized, open-label, two-arm, multicenter, interventional phase III trial in Germany. The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease.
158 patients will be enrolled and randomized 1:1 (stratified by the presence of lung and / or liver metastases) to receive Arm A: a combination of ribociclib and AI or fulvestrant; OR Arm B: capecitabine + bevacizumab OR paclitaxel +/- bevacizumab
Treatment will be continued until disease progression, intolerable toxicity or death. Progression-free survival (PFS) will be based on tumor assessments by local radiologists/investigator using RECIST v1.1 criteria. Treatment might be continued beyond RECIST-defined progressive disease (PD) in case of negligible or clinically irrelevant disease progression according to the investigator's discretion until clinically relevant disease progression or symptomatic deterioration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Multicenter, Two-arm, Phase III Study to Evaluate Efficacy and Quality of Life in Patients With Metastatic Hormone Receptor-positive HER2-negative Breast Cancer Receiving Ribociclib in Combination With Endocrine Therapy or Chemotherapy With or Without Bevacizumab in First Line|
|Actual Study Start Date :||May 24, 2018|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2026|
Experimental: Arm A
Combination of ribociclib and aromatase inhibitor or fulvestrant
Combination Product: Ribociclib and aromatase inhibitor or fulvestrant
Combination of ribociclib and aromatase inhibitor or fulvestrant
Active Comparator: Arm B
Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab
Combination Product: Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab
Capecitabine with bevacizumab OR Paclitaxel with or without bevacizumab
- Efficacy in terms of PFS [ Time Frame: Up to approximately 15 months. ]PFS is defined as time from randomization to progression of disease or death of any cause, whichever comes first. It will be assessed by imaging until progressive disease or start of next-line therapy.
- Overall Survival (OS) [ Time Frame: Up to approximately 48 months. ]OS is defined as time from randomization to death of any cause.
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 15 months. ]ORR is defined as the proportion of patients with best overall response of complete or partial response according to RECIST 1.1.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 15 months ]CBR is defined as the proportion of patients with best overall response of complete or partial response or stable disease lasting 24 weeks or more according to RECIST 1.1.
- Time To Response (TTR) [ Time Frame: Up to approximately 15 months. ]TTR is defined as time from randomization to first occurrence of any response (complete or partial) according to RECIST 1.1.
- Number of participants with Adverse Events [ Time Frame: Until 30 days after end of treatment, up to approximately 16 months. ]Type, frequency and severity (according to CTCAE v4.03) of adverse events
- Time to deterioration of ECOG performance status [ Time Frame: Until 30 days after end of treatment, up to approximately 16 months ]Time to deterioration of ECOG performance status by at least one point from baseline.
- Tolerability of treatment [ Time Frame: Until 30 days after end of treatment, up to approximately 16 months. ]By-patient listings of safety laboratory (hemoglobin, platelets, white blood cells with differentials, international normalized ratio , serum creatinine, bilirubin, Alanine-Aminotransferase (ALT) and Aspartate-Aminotransferase (AST)).
- corrected QT interval (QTc) time [ Time Frame: Until 30 days after end of treatment, up to approximately 16 months. ]By-patient listings of cardiac monitoring.
- Health-related quality of life (QoL) [ Time Frame: Up to 36 months. ]Health-related QoL will be assessed with the EORTC Quality of life questionnaire (QLQ) QLQ-C30.
- Side effects of treatment [ Time Frame: Up to 36 months. ]One question on treatment burden
- Time spent on treatment [ Time Frame: Up to 36 months ]Burden by treatment will be assessed with 4 questions on time spent on treatment
- Symptomatic PFS (sPFS) [ Time Frame: Up to approximately 15 months. ]sPFS is defined as time from randomization until symptomatic deterioration (new or worsening of persisting symptoms) or death as per local investigator.
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): NCT03462251
|Contact: Beate Niemeier, PhD||+49 761 15242 ext firstname.lastname@example.org|
|Contact: Barbara Timm, PhD||+49 761 15242 ext email@example.com|
|Gemeinschaftspraxis für Hämatologie und Onkologie||Recruiting|
|Ravensburg, Baden-Wuerttemberg, Germany, 88212|
|Contact: Thomas Decker, Prof. +49 751 3661970 firstname.lastname@example.org|
|Principal Investigator:||Thomas Decker, Prof.||Gemeinschaftspraxis für Hämatologie und Onkologie|