RecruitingNot ApplicableNCT03524430

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)


Sponsor

Rna Diagnostics Inc.

Enrollment

801 participants

Start Date

Apr 26, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a laboratory test called the RNA Disruption Assay (RDA) that analyzes biopsy samples taken during chemotherapy before breast cancer surgery, to predict how well the cancer is responding to treatment — potentially allowing doctors to personalize therapy earlier. **You may be eligible if...** - You are a woman aged 18 or older - You have been newly diagnosed with early- to mid-stage (Stage I, II, or III) invasive breast cancer - Your tumor is at least 1 cm in size - You are scheduled to receive chemotherapy before surgery (called neoadjuvant chemotherapy) - You are willing to have two small tissue biopsies taken during your chemotherapy course **You may NOT be eligible if...** - You have already had surgery, radiation, or chemotherapy for this breast cancer - Your breast cancer has spread to distant organs (Stage IV) - You have cancer in both breasts or multiple separate tumors - You are currently pregnant or breastfeeding - You have had another cancer in the past (except treated early-stage skin or cervical cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECore 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.


Locations(7)

Siteman Cancer Center

St Louis, Missouri, United States

Sunnybrook Health Sciences Center

Toronto, Canada

Institut de Cancerologie de Strasbourg

Strasbourg, France

Universitätsklinikum Münster

Münster, Germany

SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

Cremona, Italy

NZOZ Neuromed

Lublin, Poland

Hospital U. 12 de Octubre

Madrid, Spain

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NCT03524430


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