Last reviewed · How we verify
NCT07132502
Treatment Intermittent Periods Based on ctDNA-MRD（Circulating Tumor DNA-minimal Residual Disease） Status in Advanced HER2-Positive Breast Cancer
trial testing ctDNA MRD in Breast Cancer in 24 participants. Not yet recruiting.
8 July 2027
Quick facts
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 24 |
| Start date | 25 August 2025 |
| Primary completion | 8 July 2027 |
| Estimated completion | 15 July 2027 |
Drugs / interventions tested
- ctDNA MRD
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer seriously threatens the health of women worldwide. The HER-2-positive subtype accounts for approximately 15% to 20%, featuring strong invasiveness and poor prognosis. In recent years, anti-HER-2 targeted therapy has developed rapidly. The application of various drugs has improved the remission rate of advanced patients, leading to an increase in the number of patients achieving complete remission (CR). However, CR patients still face the risk of recurrence. Moreover, treatment decisions are confronted with dilemmas such as the contradiction between the cumulative toxicity of continuous treatment and the increased risk of recurrence due to premature drug withdrawal, as well as the lack of step-down treatment guidance strategies in disease-free states. Circulating tumor DNA (ctDNA)-mediated molecular residual disease (MRD) detection shows potential in predicting prognosis and monitoring recurrence in various solid tumors, with certain progress also made in the field of breast cancer. However, there are few studies on its application in guiding treatment decisions for advanced HER-2-positive breast cancer patients after CR. This study adopts a prospective, observational cohort study design. It intends to screen advanced HER-2-positive breast cancer patients, include those who have achieved CR with negative ctDNA-MRD and negative CA153, and divide them into a drug intermission group and a continued salvage treatment group based on patients' autonomous choices. The study will conduct long-term follow-up on the two groups, dynamically monitor the ctDNA-MRD status, observe the disease changes when treatment is paused in the drug intermission group, as well as the treatment response and disease progression in the continued salvage treatment group. It will evaluate the impact of the drug intermission strategy on prognostic indicators such as progression-free survival (PFS) and overall survival (OS), clarify whether ctDNA-MRD can accurately predict recurrence risk to guide individualized treatment, explore the feasibility and safety of the drug intermission strategy to balance efficacy and toxicity, screen patients with good prognosis to provide a basis for step-down treatment, and promote precision treatment for advanced HER-2-positive breast cancer, filling the research gap.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07132502
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy · NA · not yet recruiting
- NCT07537049 — BR101 in Patients With Relapsed/Refractory Multiple Myeloma · Phase 1 · not yet recruiting
- NCT07187154 — The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy · NA · not yet recruiting
- NCT07530549 — A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Che · Phase 2 · not yet recruiting
- NCT07507058 — Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07132502 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07132502.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing