RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy BREVITY (BREVITY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03524430|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Female||Procedure: Core needle biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||594 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY)|
|Actual Study Start Date :||April 26, 2018|
|Estimated Primary Completion Date :||April 26, 2025|
|Estimated Study Completion Date :||October 26, 2025|
Experimental: Single Interventional Study Arm
There will be 2 biopsy collection time points with 2 core needle biopsy specimens taken at each biopsy collection time point for RDA analysis during neoadjuvant chemotherapy.
Procedure: Core needle biopsy
1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy.
If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation.
If there is a change of drugs, the second biopsy (2 specimens) will be performed at ~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin.
- Pathological complete response (pCR) [ Time Frame: At surgery after completion of neoadjuvant therapy ](ypT0,ypN0) / (ypTis,ypN0)
- Disease-free survival [ Time Frame: 5 years of survival follow-up ]Time between diagnosis and first event of progression or death
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): NCT03524430
|Contact: Sanaa Noubir, PhDfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine-Siteman Cancer Center||Suspended|
|Saint Louis, Missouri, United States, 63130|
|Sunnybrook Research Institute||Suspended|
|Toronto, Ontario, Canada|
|ASST ddi Cremona U.O. Multidisciplinare die Patologia Mammaria||Recruiting|
|Principal Investigator:||Daniele Generali, MD||SST di Cremona Multidisciplinare di Patologia Mammaria, Italy|
|Principal Investigator:||Foluso Ademuyiwa, MD||Washington University School of Medicine, St Louis, USA|
|Principal Investigator:||Maureen Trudeau, MD||Sunnybrook Health Sciences Center, Toronto, Canada|