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New biopsy test could predict chemo success in breast cancer

NCT ID NCT03524430

Knowledge-focused Sponsor: Rna Diagnostics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new lab test called the RNA Disruption Assay (RDA) to see if it can tell how well breast cancer is responding to chemotherapy. Researchers will take small tissue samples (biopsies) from the tumor at specific times during treatment and analyze them. The goal is to see if the test results match up with whether the tumor completely disappears after treatment. About 800 women with early-stage breast cancer are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a way to tell early on whether chemotherapy is working for a breast cancer patient, allowing them to switch treatments sooner if needed.
What could go wrong
This is an observational study, not a treatment trial. The test is still being validated and may not reliably predict outcomes for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 801 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Women aged at least 18 years; * Patients must be able to provide informed consent and sign the informed consent form to participate in the RDA study before any study procedures starts; * Newly diagnosed clinical stage I, II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal; * Tumour size at least 1 cm in one dimension by clinical or radiographic exam (WHO criteria); * Must have histological confirmation of invasive breast cancer of any subtype or grade; * Patient is scheduled for neoadjuvant chemotherapy +/- antibodies and +/- other drugs according to Standard of Care; * Patient willing to have 2 research core needle biopsies (for RDA) taken at 2 collection timepoints during neoadjuvant chemotherapy treatment. Exclusion Criteria * Patient who has had prior local (i.e. surgery or radiotherapy) or systemic (i.e. endocrine or cytotoxic) therapy for the current breast cancer; * Participation in another interventional clinical trial with concurrent treatment with experimental drugs to treat the current breast cancer during the period of neoadjuvant therapy (from diagnosis until surgery); * Stage IV breast cancer; * Bilateral or multicentric breast tumour; * Prior malignant disease except curatively treated in-situ maligancies; * Concurrent pregnancy; * Breast feeding woman; * Concurrent medical, psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial; * Reasons indicating risk of poor compliance with study procedures; * Patient not able to consent;

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Conditions

The condition(s) this trial relates to.

breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasm female

Contacts and locations

Locations

  • Hospital U. 12 de Octubre

    Madrid, Spain

  • Institut de Cancerologie de Strasbourg

    Strasbourg, France

  • NZOZ Neuromed

    Lublin, Poland

  • SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

    Cremona, Italy

  • Siteman Cancer Center

    St Louis, Missouri, 63129, United States

  • Sunnybrook Health Sciences Center

    Toronto, Canada

  • Universitätsklinikum Münster

    Münster, Germany

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