NCT05333874

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

Active, enrolled EARLY_PHASE1 Last updated 9 February 2026

What this trial tests

EARLY_PHASE1 trial testing Neoadjuvant chemotherapy administered before surgical extraction of a tumor in Breast Cancer, Early-Onset in 34 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 April 2022

Primary endpoint
28 November 2027

28 November 2027

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	34
Start date	6 April 2022
Primary completion	28 November 2027
Estimated completion	28 November 2027
Sites	12 locations across United States

Drugs / interventions tested

• Neoadjuvant chemotherapy administered before surgical extraction of a tumor — full drug profile →
• Observational — full drug profile →

Conditions studied

• Breast Cancer, Early-Onset — all drugs for Breast Cancer, Early-Onset →

Sponsor

Rutgers, The State University of New Jersey

Who can join

18 and older, any sex, with Breast Cancer, Early-Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective:

1\) To examine the impact of Circulating tumor DNA (ctDNA) (expressed as mean tumor molecules per ml) on treatment decision making in patients with early stage breast cancer after neoadjuvant therapy and surgery

Secondary Objectives:

1. Understand ctNDA kinetics in the neoadjuvant and adjuvant setting
2. To identify any associations between clinical staging and measurable ctDNA

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Circulating Tumor DNA in the Management of Early-Stage Breast Cancer.
   Vlataki K, Antonouli S, Kalyvioti C, Lampri E, et al · · 2023 · cited 23× · PMID 37371043 · DOI 10.3390/cells12121573
2. Beyond traditional biopsies: the emerging role of ctDNA and MRD on breast cancer diagnosis and treatment.
   Sabit H, Attia MG, Mohamed N, Taha PS, et al · · 2025 · cited 4× · PMID 40050490 · DOI 10.1007/s12672-025-01940-6
3. Minimal residual disease in solid tumors: Clinical applications and future directions.
   Abdo T, Alhalabi A, Yaghi S, Aloran M, et al · · 2026 · PMID 41604278 · DOI 10.1002/cncr.70286