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NCT Number: NCT05345860

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

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.

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Huanxing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The MRD strategy for high risk or MRD+ TNBC patients

Other

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+ patients

Other

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+ patients

Other

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 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:

  • 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+ patients

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Adverse events (AEs)

    Time frame: Up to 5 years

    The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.

  5. 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.

  6. 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.

Other outcomes

  1. Time from MRD turning positive until clinical relapse

    Time frame: Up to 5 years

    the mean time from MRD turning positive until clinical relapse

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Ma

CONTACT

[email protected]

86-10-87788060

Hongnan Mo

CONTACT

86-10-87788120

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Beijing Huanxing Cancer Hospital
  • Chinese Academy of Medical Sciences

Registry information

Official study title

Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study

Acronym: AMENDER

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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