Early-stage Breast CancerAMENDERNCT05345860
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
A study testing The MRD strategy for high risk or MRD+ TNBC patients, The MRD strategy for high risk or MRD+ HER2+ patients and The MRD strategy for high risk or MRD+ ER+ patients in people with Early-stage Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- The MRD strategy for high risk or MRD+ TNBC patients, The MRD strategy for high risk or MRD+ HER2+ patients and The MRD strategy for high risk or MRD+ ER+ patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 24 Mar 2022to 24 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hongnan Mo contact
China3 sites, 3 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Ma, 86-10-87788060, drmafei@126.com
- Recruiting
Beijing Huanxing Cancer Hospital
Beijing, Beijing Municipality
Xiaoying Sun, 15910905228
- Not yet recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center
Langfang, Hebei
Kaiping Ou, 8615901262958
About this study
Official title: Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Early-stage Breast Cancer
- Being 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MRD strategy for high risk or MRD+ TNBC patientsOther
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.
The MRD strategy for high risk or MRD+ HER2+ patientsOther
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.
The MRD strategy for high risk or MRD+ ER+ patientsOther
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.
The MRD strategy for low risk and MRD- TNBC patientsOther
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.
The MRD strategy for low risk and MRD- HER2+ patientsOther
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.
The MRD strategy for low risk and MRD- ER+ patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TNBC with high risk or MRD+ | Experimental | 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. Receives: Other: The MRD strategy for high risk or MRD+ TNBC patients |
| HER2+ with high risk or MRD+ | Experimental | 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. Receives: Other: The MRD strategy for high risk or MRD+ HER2+ patients |
| ER+ with high risk or MRD+ | Experimental | 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. Receives: Other: The MRD strategy for high risk or MRD+ ER+ patients |
| TNBC with low risk and MRD- | Experimental | 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. Receives: Other: The MRD strategy for low risk and MRD- TNBC patients |
| HER2+ with low risk and MRD- | Experimental | 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. Receives: Other: The MRD strategy for low risk and MRD- HER2+ patients |
| ER+ with low risk and MRD- | Experimental | 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. Receives: Other: The MRD strategy for low risk and MRD- ER+ patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years disease free survival(DFS)
the period after curative treatment [disease eliminated] when no disease can be detected
Measured: 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 outcomes (6)
5 years disease free survival(DFS)
the period after curative treatment [disease eliminated] when no disease can be detected
Measured: 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)
the period after curative treatment [disease eliminated] when no disease can be detected
Measured: 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)
OS was defined as the time from the date of radical surgery to the date of death from any cause
Measured: From date of radical surgery until the date of death from any cause, assessed up to 60 months
Adverse events (AEs)
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start24 Mar 2022
- Primary completion24 Mar 2024 (estimated)
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Huanxing Cancer Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Fei Ma, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345860
- Sponsor's protocol ID
- NCC3397
- Acronym
- AMENDER
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05345860
- Acronym / sponsor ID
- AMENDER / NCC3397
- Conditions
- Early-stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Huanxing Cancer Hospital, Chinese Academy of Medical Sciences
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 24 Mar 2024 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TNBC with high risk or MRD+ | Experimental | Other: The MRD strategy for high risk or MRD+ TNBC patientsTNBC 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+ with high risk or MRD+ | Experimental | Other: The MRD strategy for high risk or MRD+ HER2+ patientsHER2+ 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+ with high risk or MRD+ | Experimental | Other: The MRD strategy for high risk or MRD+ ER+ patientsER+ 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 with low risk and MRD- | Experimental | Other: The MRD strategy for low risk and MRD- TNBC patientsTNBC 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+ with low risk and MRD- | Experimental | Other: The MRD strategy for low risk and MRD- HER2+ patientsHER2+ 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+ with low risk and MRD- | Experimental | Other: The MRD strategy for low risk and MRD- ER+ patientsER+ 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The MRD strategy for high risk or MRD+ TNBC patientsStandard 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. | Other | TNBC with high risk or MRD+ |
| The MRD strategy for high risk or MRD+ HER2+ patientsStandard 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. | Other | HER2+ with high risk or MRD+ |
| The MRD strategy for high risk or MRD+ ER+ patientsStandard 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. | Other | ER+ with high risk or MRD+ |
| The MRD strategy for low risk and MRD- TNBC patientsStandard 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. | Other | TNBC with low risk and MRD- |
| The MRD strategy for low risk and MRD- HER2+ patientsStandard 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. | Other | HER2+ with low risk and MRD- |
| The MRD strategy for low risk and MRD- ER+ patientsStandard 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. | Other | ER+ with low risk and MRD- |
Primary outcome
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
6 secondary outcomes
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
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
Overall Survival(OS)
Time frame: 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
quality of life (QoL)
Time frame: Up to 5 years
quality of life (QoL)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongnan Mo contact
Fei Ma principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MRD strategy for high risk or MRD+ TNBC patients, The MRD strategy for high risk or MRD+ HER2+ patients and The MRD strategy for high risk or MRD+ ER+ patients in people with Early-stage Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Ma (86-10-87788060, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.