- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05345860
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer (AMENDER)
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
- Other: The MRD strategy for high risk or MRD+ TNBC patients
- Other: The MRD strategy for high risk or MRD+ HER2+ patients
- Other: The MRD strategy for high risk or MRD+ ER+ patients
- Other: The MRD strategy for low risk and MRD- TNBC patients
- Other: The MRD strategy for low risk and MRD- HER2+ patients
- Other: The MRD strategy for low risk and MRD- ER+ patients
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fei Ma
- Phone Number: 86-10-87788060
- Email: drmafei@126.com
Study Contact Backup
- Name: Hongnan Mo
- Phone Number: 86-10-87788120
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Fei Ma
- Phone Number: 86-10-87788060
- Email: drmafei@126.com
-
Beijing, Beijing, China
- Recruiting
- Beijing Huanxing Cancer Hospital
-
Contact:
- Xiaoying Sun
- Phone Number: 15910905228
-
-
Hebei
-
Langfang, Hebei, China
- Not yet recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
-
Contact:
- Kaiping Ou
- Phone Number: 8615901262958
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects aged ≥18 years (inclusive).
- Histologically confirmed, perioperative invasive breast cancer that is resectable without metastasis(stage I-III).
- No anti-breast cancer systematic therapy received, and planning to receive surgery and systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
With Adequate Organ Function:
a. Bone marrow function: Hemoglobin ≥ 10 g/dL; Absolute leucocyte count ≥ 4×10^9/L; Absolute neutrophil count ≥ 1.5×10^9/L; Platelets ≥ 100 × 10^9/L; b. Liver function (based on the normal values specified by study site): Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; c. Renal function (based on the normal values specified by study site): Serum creatinine ≤ 1.5 × ULN.
- The patients voluntarily signed an informed consent form.
Exclusion Criteria:
- Known to have other aggressive malignant tumor that is progressing or requires systemic treatment in the past 5 years (does not exclude subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast ductal carcinoma in situ or cervical cancer in situ that has received curative treatment).
- Have a clear history of neurological or mental disorders, including epilepsy or dementia, etc.; have a history of psychotropic drug abuse or drug abuse.
- Known history of allergy to the drug components in MRD strategy; history of immunodeficiency, or history of organ transplantation.
- There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
- Female patients during pregnancy or lactation.
- The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TNBC with high risk or MRD+
TNBC patients with clinical high risk or post-operation 1st MRD tested positive. It's possible that this arm will be divided into many sub-arms considering the different kinds of intensive adjuvant therapies and the adopting of MRD strategy. |
Standard adjuvant chemotherapy + additional chemotherapy:
In the period of once 3 months follow-up, if MRD remains positive, the additional chemotherapy will be changed for at most once. |
Experimental: HER2+ with high risk or MRD+
HER2+ patients with clinical high risk or post-operation 1st MRD tested positive. It's possible that this arm will be divided into many sub-arms considering the different kinds of intensive adjuvant therapies and the adopting of MRD strategy. |
Standard adjuvant chemotherapy + intensive targeted therapy:
In the period of once 3 months follow-up, if MRD remains positive, the intensive targeted therapy will be changed for at most once. |
Experimental: ER+ with high risk or MRD+
ER+ patients with clinical high risk or post-operation 1st MRD tested positive. It's possible that this arm will be divided into many sub-arms considering the different kinds of intensive adjuvant therapies and the adopting of MRD strategy. |
Standard adjuvant chemotherapy + intensive endocrine therapy:
In the period of once 3 months follow-up, if MRD remains positive, the intensive endocrine therapy will be changed for at most once. |
Experimental: TNBC with low risk and MRD-
TNBC patients with low clinical risk and post-operation 1st MRD tested negative. It's possible that this arm will be divided into many sub-arms considering the different kinds of standard adjuvant therapies and the adopting of MRD strategy. |
Standard adjuvant chemotherapy: AC-T/TC/TCb/AC. In the period of once 3 months follow-up, if MRD turns positive, additional adjuvant therapies listed in "The MRD strategy for high risk or MRD+ TNBC patients "will be added for at most twice. |
Experimental: HER2+ with low risk and MRD-
HER2+ patients with low clinical risk and post-operation 1st MRD tested negative. It's possible that this arm will be divided into many sub-arms considering the different kinds of standard adjuvant therapies and the adopting of MRD strategy. |
Standard adjuvant chemotherapy + standard targeted therapy:
In the period of once 3 months follow-up, if MRD turns positive, additional adjuvant targeted therapies listed in "The MRD strategy for high risk or MRD+ HER2+ patients "will be added for at most twice. |
Experimental: ER+ with low risk and MRD-
ER+ patients with low clinical risk and post-operation 1st MRD tested negative. It's possible that this arm will be divided into many sub-arms considering the different kinds of standard adjuvant therapies and the adopting of MRD strategy. |
Standard adjuvant chemotherapy + standard endocrine therapy:
In the period of once 3 months follow-up, if MRD turns positive, additional adjuvant endocrine therapies listed in "The MRD strategy for high risk or MRD+ ER+ patients "will be added for at most twice. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3 years disease free survival(DFS)
Time Frame: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
|
the period after curative treatment [disease eliminated] when no disease can be detected
|
From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5 years disease free survival(DFS)
Time Frame: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
|
the period after curative treatment [disease eliminated] when no disease can be detected
|
From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
|
1 years disease free survival(DFS)
Time Frame: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
|
the period after curative treatment [disease eliminated] when no disease can be detected
|
From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
|
Overall Survival(OS)
Time Frame: From date of radical surgery until the date of death from any cause, assessed up to 60 months
|
OS was defined as the time from the date of radical surgery to the date of death from any cause
|
From date of radical surgery until the date of death from any cause, assessed up to 60 months
|
Adverse events (AEs)
Time Frame: Up to 5 years
|
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
|
Up to 5 years
|
quality of life (QoL)
Time Frame: Up to 5 years
|
QoL measurement is conducted in the hospital after treatment via digital questionnaire EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) on a tablet computer.
|
Up to 5 years
|
quality of life (QoL)
Time Frame: Up to 5 years
|
QoL measurement is additionally conducted in the hospital after treatment via digital questionnaire Functional Assessment of Cancer Therapy - Breast (FACT-B) on a tablet computer.
|
Up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from MRD turning positive until clinical relapse
Time Frame: Up to 5 years
|
the mean time from MRD turning positive until clinical relapse
|
Up to 5 years
|
Coincidence rate between MRD continuing positive and clinical relapse
Time Frame: Up to 5 years
|
the coincidence rate between MRD continuing positive and clinical relapse
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fei Ma, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC3397
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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