NCT05345860 (AMENDER) is a NA clinical trial of The MRD strategy for high risk or MRD+ TNBC patients in Early-stage Breast Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Who is sponsoring NCT05345860?

NCT05345860 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

What drugs are being tested in NCT05345860?

Interventions in NCT05345860: The MRD strategy for high risk or MRD+ TNBC patients, The MRD strategy for high risk or MRD+ HER2+ patients, The MRD strategy for high risk or MRD+ ER+ patients, The MRD strategy for low risk and MRD- TNBC patients, The MRD strategy for low risk and MRD- HER2+ patients, The MRD strategy for low risk and MRD- ER+ patients.

What condition does NCT05345860 study?

NCT05345860 studies Early-stage Breast Cancer.

Is NCT05345860 still recruiting?

NCT05345860 is currently recruiting now. Last updated 26 April 2022.

Last reviewed 2022-04-26 · How we verify

NCT05345860: AMENDER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer

Recruiting now NA Last updated 26 April 2022

What this trial tests

NA trial testing The MRD strategy for high risk or MRD+ TNBC patients in Early-stage Breast Cancer in 300 participants. Currently enrolling.

Timeline

24 March 2022

Primary endpoint
24 March 2024

24 March 2027

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	24 March 2022
Primary completion	24 March 2024
Estimated completion	24 March 2027
Sites	3 locations across China

Drugs / interventions tested

The MRD strategy for high risk or MRD+ TNBC patients
The MRD strategy for high risk or MRD+ HER2+ patients
The MRD strategy for high risk or MRD+ ER+ patients
The MRD strategy for low risk and MRD- TNBC patients
The MRD strategy for low risk and MRD- HER2+ patients
The MRD strategy for low risk and MRD- ER+ patients

Conditions studied

Early-stage Breast Cancer — all drugs for Early-stage Breast Cancer →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

18 and older, female only, with Early-stage Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(DFS) as the primary endpoint. We optimize post-operation adjuvant therapy for early stage breast cancer based on the MRD strategy: patients with clinical high risk or post-operation 1st MRD tested positive will receive intensive adjuvant therapy, while patients with low clinical risk and post-operation 1st MRD tested negative will receive standard adjuvant therapy, and the treatment regimens will be adjusted every 3 months according to the change of MRD status. About 100 TNBC patients, 100 HER2+ patients, and 100 ER+ patients are planned to be enrolled.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Early-stage Breast Cancer

Currently open trials in the same condition.

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NCT05957068 — Breast Cancer Exercise Intervention Study · NA · recruiting
NCT06035016 — Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05345860 (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: 26 April 2022

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/NCT05345860.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing