Breast Cancer Clinical Trial
Official title:
A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
QT interval prolongation and neutropenia are considered to be important identified risks for
ribociclib (Kisqali® Prescribing Information, Investigator Brochure). The approved dosing
regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.
The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib
orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without
compromising the efficacy of ribociclib in combination with an NSAI in pre- and
postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy
for advanced disease. The risks of other AEs of special interest, such as neutropenia and
hepatobiliary toxicity will be evaluated in this study as well.
Approximately 350 patients will be randomly assigned to one of the below treatment arms in a
1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+
goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3
weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization
will be stratified by the presence of lung and/or liver metastases (yes versus no).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03095352 -
A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
|
||
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Recruiting |
NCT03667716 -
COM701 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT03709134 -
Genomic Markers for Measuring Metastatic Risk in Breast Cancer Following Primary Treatment
|
||
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02894398 -
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
|
Phase 2 | |
| Active, not recruiting |
NCT01857193 -
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Recruiting |
NCT03432429 -
REI-EXCISE iKnife Study
|
N/A | |
| Active, not recruiting |
NCT02139358 -
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03615573 -
Survey Study: Financial Impact of Breast Cancer Treatment
|
||
| Active, not recruiting |
NCT02295059 -
Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
|
N/A | |
| Completed |
NCT03323333 -
Psychosocial Intervention Pilot for Partners in BRCA Testing
|
N/A | |
| Terminated |
NCT01649258 -
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
|
Phase 1 | |
| Withdrawn |
NCT03285607 -
MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer
|
Phase 1 | |
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Recruiting |
NCT01992432 -
Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)
|
