Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04305236|
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Hormone Receptor Positive Breast Carcinoma||Drug: Abemaciclib Drug: Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open Label Trial of Neo-Adjuvant Abemaciclib With Fulvestrant in Patients Who Develop Localized Recurrence While on Adjuvant Endocrine Therapy With Molecular Evidence of Endocrine Resistance|
|Actual Study Start Date :||July 23, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2028|
Experimental: Abemaciclib and Fulvestrant
Abemaciclib will be administered orally at the dose of 150 mg twice daily. Fulvestrant will be administered intramuscularly at an initial loading dose of 500mg on days 1 and 15 of the first cycle and then 500 mg intramuscularly every first day of each subsequent cycle. One cycle is 28 days.
Other Name: VERZENIO™
Other Name: FASLODEX®
- Percentage of Participants with a pathological complete response [ Time Frame: From start of study treatment to surgery, on average we expect 6 months. ]This is defined as the percentage of subjects who achieve a pathological complete response (pCR). A pCR is defined by no evidence of tumor cells in the final surgical specimen.
- Overall Response Rate [ Time Frame: From start of study treatment to surgery, on average we expect 6 months. ]To assess the overall response rate to the combination of Abemaciclib and Fulvestrant. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
- Percentage of Participants who undergo breast conserving surgery [ Time Frame: From start of study treatment to surgery, on average we expect 6 months. ]This is defined as the percentage of subjects who undergo breast conserving surgery after receiving Abemaciclib and Fulvestrant
- Recurrence Disease Free Survival [ Time Frame: Up to 5 years ]Recurrence disease free survival will be defined as the time from surgery until patient develops recurrence.
- Percentage of Grade 3-5 Adverse Events [ Time Frame: From start of study treatment to surgery, on average we expect 6 months. ]To evaluate the safety and tolerability of administering Abemaciclib and Fulvestrant. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
- Percentage change in Ki 67 [ Time Frame: From start of study treatment to surgery, on average we expect 6 months. ]Percentage change in the Ki 67 will be evaluated from baseline to the treated specimen after breast surgery
- Preoperative Endocrine Prognostic Index Score [ Time Frame: From start of study treatment to surgery, on average we expect 6 months. ]The preoperative endocrine prognostic index (PEPI) Score is a score that is used in clinical trials to assess response to Neo-Adjuvant endocrine therapy. The PEPI score takes into account the tumor and nodal stage, level of ER expression and Ki 67 following neoadjuvant endocrine therapy.
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): NCT04305236
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvinefirstname.lastname@example.org|
|Contact: University of California Irvine Medical|
|United States, California|
|Chao Family Comprehensive Cancer Center, University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Ritesh Parajuli, MD 877-827-8839 email@example.com|
|Principal Investigator:||Ritesh Parajuli, MD||Chao Family Comprehensive Cancer Center|