What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as anthracyclines (e.g., doxorubicin) and taxanes (e.g., paclitaxel), are associated with several side effects. Doxorubicin can cause cardiotoxicity, leading to heart damage, and other side effects like nausea, vomiting, and hair loss. Paclitaxel is known for causing neurotoxicity, which can result in peripheral neuropathy, as well as myelosuppression, leading to decreased blood cell counts and increased infection risk. Both drugs can also cause fatigue, alopecia, and gastrointestinal disturbances. These side effects are important considerations when evaluating the overall treatment plan for breast cancer patients.

What prior FDA approvals exist?

The FDA has approved several chemotherapy drugs for the treatment of breast cancer, including doxorubicin, paclitaxel, and cyclophosphamide. These drugs are often used in combination regimens to enhance their efficacy. Doxorubicin, an anthracycline antibiotic, and paclitaxel, a taxane, are commonly used in neoadjuvant and adjuvant settings to reduce tumor size and prevent recurrence. Cyclophosphamide, an alkylating agent, is frequently combined with other chemotherapeutic agents to improve treatment outcomes. These drugs are relevant to the RNA Disruption Assay, which evaluates RNA integrity to assess the tumor's response to such chemotherapy treatments.

What other types of research exist?

Promising novel alternatives to RNA Disruption Assay for assessing tumor response to chemotherapy in breast cancer patients include CRISPR-Cas systems for RNA targeting, tracking, and editing, which offer precise manipulation and monitoring of RNA molecules. Additionally, high-throughput sequencing approaches, such as targeted DNA-seq assays, can identify novel RNA transcript variants and splicing events with greater depth and coverage. These technologies provide enhanced accuracy and detailed insights into RNA integrity and tumor response.

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RNA Disruption Assay for Breast Cancer (BREVITY Trial)

N/A

Recruiting

Led By Joke Tio

Research Sponsored by Rna Diagnostics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years of survival follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new method called RNA Disruption Assay to see if it can help doctors determine early on if breast cancer patients' tumors are responding to chemotherapy. By analyzing the tumor's RNA, the test aims to guide treatment decisions and improve patient outcomes.

Who is the study for?

This trial is for women over 18 with stage I-III breast cancer, aiming to have surgery after chemotherapy. They must be able to consent and agree to two core needle biopsies during treatment. Excluded are those with stage IV cancer, concurrent serious conditions, prior treatments for current cancer, or in another drug trial.

What is being tested?

The study tests the RNA Disruption Assay (RDA) as a tool to assess tumor response from biopsy samples taken during neoadjuvant chemotherapy. It aims to validate RDA's effectiveness in predicting treatment outcomes before surgical excision.

What are the potential side effects?

While not directly related to medication side effects, undergoing core needle biopsies may result in pain at the biopsy site, bruising, bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage I, II, or III breast cancer and aim for surgery after initial treatment.

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My tumor is at least 1 cm big.

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My breast cancer diagnosis was confirmed through tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for my current breast cancer.

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I am not in another trial for my breast cancer that involves experimental drugs.

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I had cancer before, but it was treated and considered cured.

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I am unable to give consent for medical procedures.

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I have breast cancer in both breasts or in multiple areas of one breast.

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My breast cancer is at stage IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years of survival follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years of survival follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of survival follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological complete response (pCR)

Secondary study objectives

Disease-free survival

Residual Cancer Burden

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Interventional Study ArmExperimental Treatment1 Intervention

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy and targeted therapies. Chemotherapy targets rapidly dividing cells, including cancer cells, by damaging their DNA or inhibiting cell division, which prevents tumor growth. Targeted therapies, such as trastuzumab, focus on specific molecular markers like HER2 on cancer cells, blocking their growth and survival pathways. These mechanisms are important for breast cancer patients as they help in tailoring treatments to the tumor's specific characteristics, improving the chances of a successful response and minimizing unnecessary side effects.

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