ctDNA Monitoring and Neoadjuvant Chemotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byMridula George, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mridula George, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

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.

Inclusion Criteria

I am willing to attend all scheduled medical exams and blood tests.

Participants enrolled on other systemic therapy trials may be eligible to participate in the study after discussion with principal investigator

You need to have a blood test for ctDNA when you are screened for the study.

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Exclusion Criteria

I have had cancer before, but it was either a non-dangerous skin cancer, a localized cancer that did not spread, or any other cancer that has been in complete remission for over a year.

I do not have any other type of cancer.

I have received a bone marrow or organ transplant.

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Treatment Details

Interventions

Neoadjuvant chemotherapy (Chemotherapy)

Trial OverviewThe 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.

Participant Groups

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.