Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients (ABC-POP)
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|ClinicalTrials.gov Identifier: NCT02831530|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : March 29, 2018
Cyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous cancers including breast cancer. The objective of this study is to identify if a new preoperative oral treatment, abemaciclib directed against the CDK / 6 compared to no treatment, inhibits tumor growth or induced senescence (aging) tumor.
This early study is offered to women who are going to be operated on for breast cancer with expression of hormone receptor (ER and / or PR). These women will have 3 chances to receive one for up to 14 days in the waiting period of their surgery abemaciclib as tablets. Other patients do not receive treatment. The decision to receive or no treatment will be done by a random computer draw.
The drug's effectiveness will be evaluated primarily on the biological parameters of the tumor itself when comparing surgery to before treatment. These results biomarkers will allow us to better know how this treatment and eventually will be used in future to identify patients for whom treatment with abemaciclib more efficiency.
Patients treated in the protocol will then receive treatment entirely conventional in their breast cancer within the parameters of their tumors: their participation is very limited in time.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Abemaciclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients|
|Actual Study Start Date :||March 16, 2016|
|Actual Primary Completion Date :||February 2, 2018|
|Actual Study Completion Date :||February 2, 2018|
Patients randomized to the treatment arm will start treatment from 15 days before the surgery (day 1 of the study) to receive the last dose of treatment the day before the surgical procedure (day 14 of the study). Abemaciclib will be taken orally at a dose of 150 mg/ twice a day (Every 12h +/- 2h) on day 1 to day 14. The treatment should be taken in the morning and evening with a big glass of water (250ml) at approximately the same time.
|No Intervention: No treatment|
- Anti-proliferative response [ Time Frame: Assessed 15 days after randomization ]The primary endpoint is the percentage of patients who at Day 15 have a natural logarithm of percentage positive IHC staining Ki67 of <1 for each study drug (Ki67 "absolute" antiproliferative responders).
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): NCT02831530
|Villejuif, Val De Marne, France, 94805|