ctDNA Monitoring and Neoadjuvant Chemotherapy for Breast Cancer

Recruiting at 11 trial locations

Overseen By Mridula George, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Metastatic cancer, Concurrent malignancy, Pregnancy, Transplant recipient, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 61

34 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It might depend on your specific situation, so it's best to discuss this with the trial's principal investigator.

What data supports the effectiveness of the treatment Neoadjuvant chemotherapy for breast cancer?

Research shows that monitoring circulating tumor DNA (ctDNA) during neoadjuvant chemotherapy can help predict the likelihood of cancer returning. Patients with lower ctDNA levels after treatment tend to have better outcomes, suggesting that the treatment can be effective in reducing cancer presence. ^{1 2 3 4 5}

Is ctDNA monitoring and neoadjuvant chemotherapy safe for humans?

The research does not specifically address the safety of ctDNA monitoring and neoadjuvant chemotherapy, but these treatments are commonly used in breast cancer care, suggesting they are generally considered safe for humans. ^{2 3 4 5 6}

How is neoadjuvant chemotherapy for breast cancer different from other treatments?

Neoadjuvant chemotherapy for breast cancer is unique because it is given before surgery to shrink tumors, and its effectiveness can be monitored using circulating tumor DNA (ctDNA), which helps predict patient outcomes and potential relapse. ^{2 4 5 6 7}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy and ctDNA is collected prior to each cycle

Varies based on chemotherapy regimen

Multiple visits for chemotherapy cycles

Surgery and Initial ctDNA Monitoring

Participants undergo surgery and ctDNA is collected fourteen days post-surgery

2 weeks

1 visit for surgery, 1 visit for ctDNA collection

Adjuvant Therapy and ctDNA Monitoring

Participants receive adjuvant therapy based on ctDNA results and are monitored for ctDNA re-emergence

Up to 24 months

Regular visits at 60 days, 3, 6, 9, 12, 18, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits

Treatment Details

Interventions

• Neoadjuvant chemotherapy

Trial Overview 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.

Participant Groups

Group I: Observational Experimental Treatment 1 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 chemotherapy Active Control 1 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

The study involved 31 breast cancer patients and utilized circulating tumor DNA (ctDNA) analysis at three key time points to assess tumor progression and treatment effectiveness, revealing a total of 500 somatic mutations across samples.

Mutations in specific genes like KMT2C in ctDNA were identified as potential indicators of breast cancer recurrence, suggesting that ctDNA could be a valuable tool for monitoring patients over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Circulating Tumor DNA to Predict Neoadjuvant Therapy Effectiveness and Breast Cancer Recurrence. Hao, S., Tian, W., Zhao, J., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Prognostic value of ctDNA detection in patients with early breast cancer undergoing neoadjuvant therapy: A systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA After Neoadjuvant Chemotherapy in Breast Cancer Is Associated With Disease Relapse. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Analysis of Circulating Tumor DNA to Predict Neoadjuvant Therapy Effectiveness and Breast Cancer Recurrence. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA dynamics using patient-customized assays are associated with outcome in neoadjuvantly treated breast cancer. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Blood-based genomics of triple-negative breast cancer progression in patients treated with neoadjuvant chemotherapy. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Serial circulating tumor DNA identification associated with the efficacy and prognosis of neoadjuvant chemotherapy in breast cancer. [2021]