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

NCT04803539 | Recruiting Phase 2 DMC

• 1 other identifier: SunYatsenU2H-LQ4
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.

Conditions

Breast Cancer

Keywords

stage II-III

Outcome Measures

Primary Outcomes (1)

• Invasive Disease Free Survival(IDFS)

  Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria

  60 months

Secondary Outcomes (4)

• Distant disease-free survival(DDFS)

  60 months

• Overall Survival

  60 months

• Brain metastasis rate

  60 months

• The rate of adverse effects(AEs)

  60 months

Study Arms (2)

Capecitabine

ACTIVE COMPARATOR

Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year

Drug: capecitabine

Capecitabine + Apatinib + Camrelizumab

EXPERIMENTAL

Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day, Camrelizumab 200mg intravenously, once every two weeks (Q2W), oral apatinib, 250mg, PO, qd for 1 year

Drug: capecitabine + camrelizumab + apatinib

Interventions

capecitabine DRUG

capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial)

Capecitabine

capecitabine + camrelizumab + apatinib DRUG

Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study

Capecitabine + Apatinib + Camrelizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years-old at the time of consent to participate this trial
• Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER \<=1%, PR \<=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
• positive ctDNA after curative surgery and/or adjuvant chemotherapy
• ECOG 0-2
• If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
• Patient receives adjuvant chemotherapy according to the NCCN guidelines
• Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
• Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years

You may not qualify if:

• Patient has previously received any PD1/PDL1 blockage treatment
• Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
• Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
• Patient participates another interventional clinical trial
• Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
• Patient with autoimmune disease preventing the use of camrelizumab
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; camrelizumab; apatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Qiang Liu, PhD

  Sunyat-sen Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunying Li, MD

CONTACT

86-020-34071156; lishunying@foxmail.com

Qiang Liu, PhD

CONTACT

86-020-34071157; victorlq@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 17, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2033
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)