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NCT Number: NCT04501523

A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC

Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.

Recruiting

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Key information

Conditions

Triple-negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.
  • Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.
  • ctDNA positive at baseline, after NAC or after surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Written informed consent to provide research blood samples and tumor samples
  • Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection
  • No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis

Exclusion criteria

  • Previously participated in other interventional trials
  • Previous malignancy within 3 years of breast cancer diagnosis
  • Pregnancy or breastfeeding
  • No written consent
  • Unable to receive standard NAC and subsequent radiotherapy(if needed)
  • Active autoimmune disease

Treatment and study plan

Tislelizumab

Drug

200mg, q3w, for 1 year

Capecitabine

Drug

600-750 mg/m2 PO Bid，continuous, for 1 year

Primary outcomes

  1. 5 years Disease free survival(DFS)

    Time frame: 60 months

    From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy

Secondary outcomes

  1. 5 years overall survival(OS)

    Time frame: 60 months

    From diagnosis to 5yrs or death; To determine 5-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy

  2. pathological complete remission(pCR) rate

    Time frame: 12 months

    pathological complete remission

  3. brain metastasis rate

    Time frame: 60 months

    The percentage of patients who develop brain metastasis

  4. objective response rate(ORR)

    Time frame: 12 months

    The percentage of patients who achieved PR+CR

  5. Number of Patients with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 12 months

    To determine the toxicities associated with tislelizumab in this population

  6. 10 years DFS

    Time frame: 120 months

    To determine 10-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy

  7. 10 years OS

    Time frame: 120 months

    To determine 10-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy

  8. Relapse and metastasis rate

    Time frame: 24 months

    The percentage of patients who develop brain metastasis any relapse or metastasis

Study contacts

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

Shunying Li, MD

CONTACT

[email protected]

+86-15915939702

Yudong Li, MD

CONTACT

[email protected]

020-34071156

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

Acronym: Apollo

Important dates

Study start
2020
Primary completion
2027
Study completion
2032
First posted
Aug 6, 2020
Registry last updated
Feb 21, 2023

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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