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Chemotherapy

ctDNA Monitoring and Neoadjuvant Chemotherapy for Breast Cancer

Q: Are there still opportunities to join this clinical trial?

<p>This trial, which was initially made available on April 6th 2022 and last updated November 29th 2022 is not currently accepting patients. Nevertheless, there are still 2289 other medical studies recruiting participants.</p>

Q: How many facilities are administering this trial?

<p>RWJBarnabas Health - Robert Wood Johnson University Hospital in Hamilton, Newark Beth Israel Medical Center in Newark and Monmouth Medical Center - Southern Campus in Lakewood are just 3 of the 12 medical centres looking for participants.</p>

Phase < 1

Waitlist Available

Led By Mridula George, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years

Awards & highlights

Study Summary

This triallooks at how ctDNA levels affect decisions in early stage breast cancer patients after neoadjuvant and adjuvant therapy. It also studies the levels of ctDNA in the neoadjuvant and adjuvant setting.

Who is the study for?

This trial is for adults over 18 with early stage II-III triple negative or HER2 positive breast cancer, who are fit enough for neoadjuvant therapy and surgery. They must have detectable ctDNA, be able to attend medical exams and blood draws, and not be pregnant or have other serious health issues that could affect their participation.Check my eligibility

What is being tested?

The CIPHER study is testing the role of circulating tumor DNA (ctDNA) in treatment decisions after pre-surgery chemotherapy and surgical tumor removal in early-stage breast cancer patients. It will also explore how ctDNA levels change during treatment.See study design

What are the potential side effects?

While specific side effects are not listed for this observational study, typical side effects from neoadjuvant chemotherapy can include nausea, fatigue, hair loss, increased risk of infection due to lowered white blood cell counts, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My breast cancer is Stage II-III, triple negative or HER2 positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Detectable Circulating tumor DNA ctDNA

Secondary outcome measures

Levels of Detectable Circulating tumor DNA ctDNA

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ObservationalExperimental Treatment1 Intervention

Observation for triple negative breast cancer (TNBC): No adjuvant chemotherapy. Patients may complete checkpoint inhibitor from neoadjuvant setting. human epidermal growth factor receptor 2 (HER2) positive breast cancer: complete twelve months of anti-HER2 therapy, which was initiated in neoadjuvant setting), participants in the observation arm, will be monitored for Circulating tumor DNA (ct-DNA) re-emergence and systemic therapy can be added at the time of ctDNA re-emergence.

Group II: Neoadjuvant chemotherapyActive Control1 Intervention

If Circulating tumor DNA (ctDNA) blood test is positive, change in treatment can be made. Participants will be monitored with ctDNA at 60days, 3 months, 6 months, 9 months, 12 months, 18months and 24months from surgery. The participant's core biopsy specimens will be sent to NateraTM to sequence the primary tumor. The baseline blood work for ctDNA will be collected prior to the initiation of systemic therapy. Subsequently, ctDNA will be collected prior to each cycle of neoadjuvant chemotherapy. Participants will undergo surgery and ctDNA needs to be collected fourteen days post-surgery The treating oncologist will complete a questionnaire to determine how ctDNA impacts treatment decisions in the adjuvant setting once the results from the fourteen day ctDNA is available and at the time of ctDNA re-emergence. Participants will complete participant questionnaire at 3 months, 6months, 12months and 24 months post-operatively.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,198 Total Patients Enrolled

16 Trials studying Breast Cancer

1,910 Patients Enrolled for Breast Cancer

Mridula George, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

2 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Neoadjuvant chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05333874 — Phase < 1

Breast Cancer Research Study Groups: Observational, Neoadjuvant chemotherapy

Breast Cancer Clinical Trial 2023: Neoadjuvant chemotherapy Highlights & Side Effects. Trial Name: NCT05333874 — Phase < 1

Neoadjuvant chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333874 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this clinical trial?

"This trial, which was initially made available on April 6th 2022 and last updated November 29th 2022 is not currently accepting patients. Nevertheless, there are still 2289 other medical studies recruiting participants."

Answered by AI

How many facilities are administering this trial?

"RWJBarnabas Health - Robert Wood Johnson University Hospital in Hamilton, Newark Beth Israel Medical Center in Newark and Monmouth Medical Center - Southern Campus in Lakewood are just 3 of the 12 medical centres looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage

Mridula George, MD 2022. "CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05333874.