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

NCT05345860 | Recruiting

• 1 other identifier: NCC3397
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Early-stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 5 years disease free survival(DFS)

  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)

  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)

  From date of radical surgery until the date of death from any cause, assessed up to 60 months

• Adverse events (AEs)

  Up to 5 years

• quality of life (QoL)

  Up to 5 years

Other Outcomes (2)

• Time from MRD turning positive until clinical relapse

  Up to 5 years

• Coincidence rate between MRD continuing positive and clinical relapse

  Up to 5 years

Study Arms (6)

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.

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.

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.

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.

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.

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.

Other: The MRD strategy for low risk and MRD- ER+ patients

Interventions

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.

TNBC with high risk or MRD+

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.

HER2+ with high risk or MRD+

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.

ER+ with high risk or MRD+

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.

TNBC with low risk and MRD-

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.

HER2+ with low risk and MRD-

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.

ER+ with low risk and MRD-

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Beijing Huanxing Cancer Hospital: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (3)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Huanxing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Hebei Center

Langfang, Hebei, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei Ma

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ma

CONTACT

86-10-87788060; drmafei@126.com

Hongnan Mo

CONTACT

86-10-87788120

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Medical Oncology

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 26, 2022
• Study Start: March 24, 2022
• Primary Completion: March 24, 2024
• Study Completion (Estimated): March 24, 2027
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CN (3)