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Chemotherapy

ctDNA Monitoring and Neoadjuvant Chemotherapy for Breast Cancer

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
Must not have
Any other concurrent malignancy
Bone marrow transplant or other organ transplant recipient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a blood test to find tiny pieces of tumor DNA in early-stage breast cancer patients after their first round of treatment. It aims to help doctors decide if more treatment is needed to prevent the cancer from coming back. The test looks for specific genetic markers from the tumor to see if any cancer cells are left.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any other type of cancer.
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I have received a bone marrow or organ transplant.
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My breast cancer has spread to other parts of my body.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Detectable Circulating tumor DNA ctDNA
Secondary study objectives
Levels of Detectable Circulating tumor DNA ctDNA

Side effects data

From 2023 Phase 2 trial • 1380 Patients • NCT05004181
5%
Fatigue
5%
Headache
5%
Lymphadenopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A - Cohort 1: 1 Dose of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part A - Cohort 2: 2 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part B - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part C - Cohort 8: 1 Dose of 30 μg BNT162b2 (Original Vaccine)
Part C - Cohort 7: 1 Dose of 30 μg BNT162b2 (B.1.1.529)
Part A - Cohort 3: 1 Dose of 30 μg BNT162b2 (B.1.1.7)
Part A - Cohort 4: 1 Dose of 30 μg BNT162b2 (B.1.617.2)
Part A - Cohort 5: 1 Dose of 30 μg BNT162b2 (Original Vaccine)
Part A - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part B - Cohort 1: 1 Dose 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part B - Cohort 4: 1 Dose 30 μg BNT162b2 (B.1.617.2)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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
Breast cancer treatments often include chemotherapy, endocrine therapy, and targeted therapy, each with distinct mechanisms of action. Chemotherapy works by killing rapidly dividing cancer cells, while endocrine therapy blocks hormones like estrogen that fuel certain breast cancers. Targeted therapies, such as HER2 inhibitors, specifically attack cancer cells with particular genetic mutations or protein expressions. The measurement of circulating tumor DNA (ctDNA) can help tailor these treatments by providing real-time insights into the genetic landscape of the tumor, allowing for more personalized and potentially effective treatment strategies. This is crucial for breast cancer patients as it can lead to better outcomes and reduced side effects by avoiding ineffective treatments.
Gene-expression signatures to inform neoadjuvant treatment decision in HR+/HER2- breast cancer: Available evidence and clinical implications.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
450 Previous Clinical Trials
65,678 Total Patients Enrolled
15 Trials studying Breast Cancer
1,000 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: Neoadjuvant chemotherapy, Observational
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
~18 spots leftby Nov 2027