Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015/2288 | Other Identifier | CSET Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib | Experimental | 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 treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-proliferative response | 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). | Assessed 15 days after randomization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy or hormonotherapy.
Patients receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine treatment, or radiotherapy for the currently diagnosed tumor.
Known hypersensibility to abemaciclib or any of its components.
Difficulty to swallow oral medication.
Serious uncontrolled concomitant disease that would put the patient at high risk for treatment-related complications.
Patients whose general clinical condition does not consider postponing surgery.
Inadequate organ function, evidenced by the following laboratory results:
Patients with serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis).
Patients with a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Pregnant or breastfeeding patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590451 | abemaciclib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |