What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving ctDNA measurement for treatment decision-making, include fulvestrant and targeted therapies like palbociclib. Fulvestrant can cause side effects such as hot flashes, nausea, fatigue, and injection site pain. Palbociclib, a CDK4/6 inhibitor, is associated with neutropenia, leukopenia, fatigue, nausea, and infections. These treatments may also lead to more severe adverse events, including increased risk of serious infections and blood disorders. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for breast cancer that utilize biomarkers for treatment decision-making. Notable examples include trastuzumab (Herceptin) for HER2-positive breast cancer, which targets the HER2 receptor, and palbociclib (Ibrance), a CDK4/6 inhibitor used in combination with hormone therapy for HR-positive, HER2-negative breast cancer. Additionally, olaparib (Lynparza) is approved for patients with BRCA-mutated, HER2-negative metastatic breast cancer. These treatments exemplify the shift towards personalized medicine in breast cancer care, similar to the approach being studied with ctDNA measurement.

What other types of research exist?

Promising alternatives to ctDNA measurement for breast cancer patients include: 1) Circulating Tumor Cells (CTCs) - Elevated levels of CTCs have been shown to predict progression-free survival (PFS) and overall survival (OS) in metastatic breast cancer. 2) Blood-based microRNAs - These have been identified as potential biomarkers for the diagnosis of colorectal cancer and may have similar applications in breast cancer. 3) Methylation signatures in cell-free DNA - These signatures can be used for multi-cancer detection and localization, including breast cancer. 4) Gene expression-based tests - These tests can provide prognostic information and help guide treatment decisions.

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Chemotherapy

ctDNA Monitoring and Neoadjuvant Chemotherapy for Breast Cancer

Q: What is the mechanism of action of this treatment?

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.

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 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

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

11%

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Part B - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part A - Cohort 5: 1 Dose of 30 μg BNT162b2 (Original Vaccine)

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 2: 2 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part A - Cohort 1: 1 Dose of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)

Part B - Cohort 4: 1 Dose 30 μg BNT162b2 (B.1.617.2)

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 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)

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.

0 / 6Eligibility 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

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.