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

Primary Purpose

Triple-negative Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
capecitabine
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-negative Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sunyat-sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

A

B

C

D

Arm Description

ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine

ctDNA positive, non-pCR Intervention: capecitabine(standard care)

ctDNA positive, pCR Intervention: capecitabine

Follow up(standard care)

Outcomes

Primary Outcome Measures

5 years Disease free survival(DFS)
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 Outcome Measures

5 years overall survival(OS)
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
pathological complete remission(pCR) rate
pathological complete remission
brain metastasis rate
The percentage of patients who develop brain metastasis
objective response rate(ORR)
The percentage of patients who achieved PR+CR
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
To determine the toxicities associated with tislelizumab in this population
10 years DFS
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
10 years OS
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
Relapse and metastasis rate
The percentage of patients who develop brain metastasis any relapse or metastasis

Full Information

First Posted
August 3, 2020
Last Updated
February 16, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04501523
Brief Title
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Acronym
Apollo
Official Title
A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine
Arm Title
B
Arm Type
Active Comparator
Arm Description
ctDNA positive, non-pCR Intervention: capecitabine(standard care)
Arm Title
C
Arm Type
Experimental
Arm Description
ctDNA positive, pCR Intervention: capecitabine
Arm Title
D
Arm Type
No Intervention
Arm Description
Follow up(standard care)
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
200mg, q3w, for 1 year
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
600-750 mg/m2 PO Bid，continuous, for 1 year
Primary Outcome Measure Information:
Title
5 years Disease free survival(DFS)
Description
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
Time Frame
60 months
Secondary Outcome Measure Information:
Title
5 years overall survival(OS)
Description
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
Time Frame
60 months
Title
pathological complete remission(pCR) rate
Description
pathological complete remission
Time Frame
12 months
Title
brain metastasis rate
Description
The percentage of patients who develop brain metastasis
Time Frame
60 months
Title
objective response rate(ORR)
Description
The percentage of patients who achieved PR+CR
Time Frame
12 months
Title
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
Description
To determine the toxicities associated with tislelizumab in this population
Time Frame
12 months
Title
10 years DFS
Description
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
Time Frame
120 months
Title
10 years OS
Description
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
Time Frame
120 months
Title
Relapse and metastasis rate
Description
The percentage of patients who develop brain metastasis any relapse or metastasis
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shunying Li, MD
Phone
+86-15915939702
Email
lishunying@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yudong Li, MD
Phone
020-34071156
Email
910870698@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Liu, MD
Organizational Affiliation
Sunyat-sen Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunyat-sen Memorial Hospital
City
Guandong
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shunying Li
Phone
+86-15915939702
Email
lishunying@foxmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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