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

Primary Purpose

Early-stage Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-stage Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
  • Beijing Huanxing Cancer HospitalRecruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

TNBC with high risk or MRD+

HER2+ with high risk or MRD+

ER+ with high risk or MRD+

TNBC with low risk and MRD-

HER2+ with low risk and MRD-

ER+ with low risk and MRD-

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

3 years disease free survival(DFS)
the period after curative treatment [disease eliminated] when no disease can be detected

Secondary Outcome Measures

5 years disease free survival(DFS)
the period after curative treatment [disease eliminated] when no disease can be detected
1 years disease free survival(DFS)
the period after curative treatment [disease eliminated] when no disease can be detected
Overall Survival(OS)
OS was defined as the time from the date of radical surgery to the date of death from any cause
Adverse events (AEs)
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
quality of life (QoL)
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.
quality of life (QoL)
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.

Full Information

First Posted
April 18, 2022
Last Updated
April 21, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Beijing Huanxing Cancer Hospital, Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
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1. Study Identification

Unique Protocol Identification Number
NCT05345860
Brief Title
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Acronym
AMENDER
Official Title
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
March 24, 2024 (Anticipated)
Study Completion Date
March 24, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Beijing Huanxing Cancer Hospital, Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
MRD will be tested with tumor-informed personalized panel in this trail. The adjuvant therapies in the MRD strategy are all standard therapies in guidelines of China or abroad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNBC with high risk or MRD+
Arm Type
Experimental
Arm Description
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.
Arm Title
HER2+ with high risk or MRD+
Arm Type
Experimental
Arm Description
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.
Arm Title
ER+ with high risk or MRD+
Arm Type
Experimental
Arm Description
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.
Arm Title
TNBC with low risk and MRD-
Arm Type
Experimental
Arm Description
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.
Arm Title
HER2+ with low risk and MRD-
Arm Type
Experimental
Arm Description
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.
Arm Title
ER+ with low risk and MRD-
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The MRD strategy for high risk or MRD+ TNBC patients
Intervention Description
Standard adjuvant chemotherapy + additional chemotherapy: BRCA positive patients: standard adjuvant chemotherapy + olaparib BRCA negative patients: standard adjuvant chemotherapy + capecitabine In the period of once 3 months follow-up, if MRD remains positive, the additional chemotherapy will be changed for at most once.
Intervention Type
Other
Intervention Name(s)
The MRD strategy for high risk or MRD+ HER2+ patients
Intervention Description
Standard adjuvant chemotherapy + intensive targeted therapy: Neoadjuvant therapy non-pCR patients: standard adjuvant chemotherapy completed+ T-DM1/HP Neoadjuvant therapy pCR patients: standard adjuvant chemotherapy completed + HP Adjuvant therapy patients: AC-T/TCb + HP In the period of once 3 months follow-up, if MRD remains positive, the intensive targeted therapy will be changed for at most once.
Intervention Type
Other
Intervention Name(s)
The MRD strategy for high risk or MRD+ ER+ patients
Intervention Description
Standard adjuvant chemotherapy + intensive endocrine therapy: Premenopausal patients: Standard adjuvant chemotherapy followed by OFS + TAM/TOR, OFS + ANA/LET/EXE, or OFS + ANA/LET/EXE + Abemaciclib. Postmenopausal: Standard adjuvant chemotherapy followed by ANA/LET/EXE + Abemaciclib. In the period of once 3 months follow-up, if MRD remains positive, the intensive endocrine therapy will be changed for at most once.
Intervention Type
Other
Intervention Name(s)
The MRD strategy for low risk and MRD- TNBC patients
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The MRD strategy for low risk and MRD- HER2+ patients
Intervention Description
Standard adjuvant chemotherapy + standard targeted therapy: Neoadjuvant therapy pCR patients: standard adjuvant chemotherapy (AC-T/TC/TCb) completed + H. Adjuvant therapy patients: AC-T/TC/TCb/wP + H. 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.
Intervention Type
Other
Intervention Name(s)
The MRD strategy for low risk and MRD- ER+ patients
Intervention Description
Standard adjuvant chemotherapy + standard endocrine therapy: Premenopausal patients: Standard adjuvant chemotherapy followed by TAM/TOR. Postmenopausal patients: Standard adjuvant chemotherapy followed by ANA/LET/EXE. 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.
Primary Outcome Measure Information:
Title
3 years disease free survival(DFS)
Description
the period after curative treatment [disease eliminated] when no disease can be detected
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
Secondary Outcome Measure Information:
Title
5 years disease free survival(DFS)
Description
the period after curative treatment [disease eliminated] when no disease can be detected
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
Title
1 years disease free survival(DFS)
Description
the period after curative treatment [disease eliminated] when no disease can be detected
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
Title
Overall Survival(OS)
Description
OS was defined as the time from the date of radical surgery to the date of death from any cause
Time Frame
From date of radical surgery until the date of death from any cause, assessed up to 60 months
Title
Adverse events (AEs)
Description
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
Time Frame
Up to 5 years
Title
quality of life (QoL)
Description
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.
Time Frame
Up to 5 years
Title
quality of life (QoL)
Description
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.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Time from MRD turning positive until clinical relapse
Description
the mean time from MRD turning positive until clinical relapse
Time Frame
Up to 5 years
Title
Coincidence rate between MRD continuing positive and clinical relapse
Description
the coincidence rate between MRD continuing positive and clinical relapse
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Ma
Phone
86-10-87788060
Email
drmafei@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hongnan Mo
Phone
86-10-87788120
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Ma
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Ma
Phone
86-10-87788060
Email
drmafei@126.com
Facility Name
Beijing Huanxing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoying Sun
Phone
15910905228
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
City
Langfang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiping Ou
Phone
8615901262958

12. IPD Sharing Statement

Learn more about this trial

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

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