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| Name | Class |
|---|---|
| Beijing Huanxing Cancer Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The MRD strategy for high risk or MRD+ TNBC patients | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3 years disease free survival(DFS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 5 years disease free survival(DFS) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from MRD turning positive until clinical relapse | the mean time from MRD turning positive until clinical relapse | Up to 5 years |
| Coincidence rate between MRD continuing positive and clinical relapse |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Ma | Contact | 86-10-87788060 | drmafei@126.com | |
| Hongnan Mo | Contact | 86-10-87788120 |
| Name | Affiliation | Role |
|---|---|---|
| Fei Ma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| 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. |
|
| 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. |
|
|
| The MRD strategy for high risk or MRD+ HER2+ patients | Other | 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. |
|
| The MRD strategy for high risk or MRD+ ER+ patients | Other | 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. |
|
| The MRD strategy for low risk and MRD- TNBC patients | Other | 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+ patients | Other | 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. |
|
| The MRD strategy for low risk and MRD- ER+ patients | Other | 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. |
|
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) | 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) | The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0. | 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. | 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. | Up to 5 years |
the coincidence rate between MRD continuing positive and clinical relapse
| Up to 5 years |
| Beijing Huanxing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center | Not yet recruiting | Langfang | Hebei | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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