Recommended Phase II Dose (RP2D)
| Group | Value (dose in mg) |
|---|---|
| Tamoxifen and Ribociclib With Goserelin | 400 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
NCT0258667523 Feb 2016 to 27 Oct 2021
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast cancer.
Experimental
Tamoxifen and Ribociclib with Goserelin
Phase I dose escalation followed by Phase Ib dose expansion. Tamoxifen and Ribociclib, with Goserelin added for premenopausal or peri-menopausal participants. Ribociclib: Capsules/Tablets for oral use 400 mg OR 600 mg Days 1-21 of each 28 day cycle or daily. Tamoxifen: Tablets for oral use 20 mg daily (all days of every cycle without interruption). Goserelin: Subcutaneous injection 3.6 mg Day 1 of each 28 day cycle.
Outcomes the sponsor listed as primary.
Recommended Phase II Dose (RP2D)
Time frame · Up to 12 months
400-600 mg of Ribociclib, when taken with Tamoxifen 20 mg. The Phase I portion of the study is a dose escalation to confirm the dose limiting toxicity (DLT) and the RP2D for ribociclib with Tamoxifen. DLT is defined as an adverse event or abnormal laboratory value assessed as having a reasonable possibility related to the study medication, unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) with LEE011 and Tamoxifen. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading. In this study, a DLT will occur if CTCAE grade 4 neutropenia lasts more than 4 consecutive days, if CTCAE grade 3 thrombocytopenia is associated with clinically significant bleeding or if there is grade 4 thrombocytopenia.
Progression-free Survival (PFS) at Six Months
Time frame · 6 months
Occurrence of Progression Survival at 6 months. PFS: On study date to date of progression or the same as overall survival time if not progressed. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Overall Survival (OS) at Six Months
Time frame · 6 months
Occurrence of Overall Survival at 6 months. OS: On study date to expired date or last visit date if not deceased.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (dose in mg) |
|---|---|
| Tamoxifen and Ribociclib With Goserelin | 400 |
| Group | Value (percentage of participants) |
|---|---|
| Tamoxifen and Ribociclib With Goserelin | 57.1 |
| Group | Value (percentage of participants) |
|---|---|
| Tamoxifen and Ribociclib With Goserelin | 83.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Tamoxifen and Ribociclib With GoserelinAll participants were enrolled and treated on Cohort 1 (Ribociclib 400 mg PO D1-21; Tamoxifen 20 mg PO QD (1) only. | 0 / 7 | 2 / 7 | 7 / 7 |
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