Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer (NeoSTEP)

June 3, 2023 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer, an Open-labeled, Single Arm Trial

The goal of this clinical trial is to learn about the efficacy and safety of short-term sintilimab in combination with taxane and carboplatin for neoadjuvant therapy in female early-stage triple-negative breast caner patients aging from 18 to 70 years with unilateral and invasive primary lesions above 1cm. The main questions it aims to answer are:

  1. Does short-term sintilimab in combination with taxane and carboplatin lead to acceptible pathological complete response (pCR) rates, objective response rates (ORR), event-free survival (EFS) and overall survival (OS)?
  2. Does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term ICIs reported in literature?

Participants will be given 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin before surgery. An optional core-needle biopsy is performed after completing 2 cycles of sintilimab. All participants will be given regular follow-up post surgery according to ASCO guidelines.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 18-70 years, female;
  2. Unilateral, invasive, primary breast cancer, T≥1cm, cN0-3, M0;
  3. Immunohistochemistry(IHC): ER, PR<10%; HER-2 IHC "0", OR IHC "+", OR IHC "++" AND fluorescence in situ hybridization (FISH) negative;
  4. At least one measurable lesion according to RECIST V1.1;
  5. Newly or recently-collected core needle biopsy specimen of the primary lesion available for PD-L1 status determination;
  6. ECOG score 0 or 1 within 10 days prior to drug administration;

  7. Currently not pregnant or breastfeeding, and meet at least one of the following conditions:

    1. NOT women of childbearing potential (WOCBPs).
    2. WOCBPs that strictly adopt contraceptive measures during treatment and within at least 6 months after last drug administration.
  8. Organs well-functioned according to laboratory examination and imaging;
  9. Having good compliance with treatment plans, being capable of understanding the research process, and having signed a written informed consent.

Exclusion Criteria:

  1. Bilateral invasive breast cancer or metastatic (Stage IV) breast cancer;

  2. With severe cardiovascular conditions:

    1. Myocardial infarction, acute coronary syndrome or PCI/CABG within 6 months;
    2. Current NYHA II-IV congestive heart failure (CHF) or past history of NYHA III-IV CHF.
  3. Immunodeficiency, or undergoing systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to drug administration;
  4. Active autoimmune diseases requiring systemic treatment within the past 2 years;
  5. Known history of active tuberculosis caused by Bacillus Tuberculosis;
  6. History of non infectious pneumonia requiring steroid treatment, or active pneumonia of all types;
  7. Severe systemic infections, or other serious illnesses;
  8. History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
  9. Known history of human immunodeficiency virus (HIV) infection;
  10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
  11. Known allergy or intolerance to therapeutic drugs or their excipients;
  12. History of receiving cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason;
  13. History of receiving anti PD-1, anti PD-L1, or anti PD-L2 drugs; or targeted drugs that act on stimulating or co-inhibitory T cell receptors (CTLA-4, OX 40, CD137 etc.);
  14. Enrolled in a study of an investigational drug/instrument and given intervention within 4 weeks prior to drug administration for regular drugs/instruments and within 12 months for anticancer or anti-proliferative drugs/instruments;
  15. Live vaccine (including but not limited to the following: measles, mumps, rubella, chickenpox/shingles, yellow fever, rabies, BCG, typhoid vaccines, and nasal influenza vaccines such as FluMist®) inoculation within 30 days prior to drug administration;
  16. History of mental illness or drug abuse that may affect compliance with trial requirements;
  17. During pregnancy or breastfeeding, or WOCABs that refuse to adopt strict contraceptive measures;
  18. Deemed to be not appropriate for participating in this study by researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short-term Sintilimab in Combination With Taxane and Carboplatin
Prior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin
Procedure: Surgery
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Drug: Taxane and Carboplatin

Nab-paclitaxel 100mg/m2+ Carboplatin AUC2 by intravenous (IV) infusion on day1, day8 and day15, every 4 weeks, for 4 cycles.

or Docetaxel 75mg/m2+ Carboplatin AUC5 by intravenous (IV) infusion on day1, every 3 weeks, for 4 cycles.

or Paclitaxel 80mg/m2+ Carboplatin AUC2 by intravenous (IV) infusion on day1, day8 and day15, every 4 weeks, for 4 cycles.

Drug: Short-term Sintilimab
Sintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rates
Time Frame: At surgery.
The percentage of participants with the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).
At surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rates (ORR)
Time Frame: At surgery.
The percentage of participants with complete response (CR) and partial response (PR) in accordance with RECIST V1.1 definitions.
At surgery.
Event-free survival (EFS)
Time Frame: From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)
EFS is defined as the time from diagnosis to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST V1.1. Disease recurrence (local, regional, or distant) after surgery. Contralateral breast cancer. Second primary tumor. Death from any cause.
From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)
Overall survival (OS)
Time Frame: Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)
OS was defined as the time from diagnosis to death from any cause.
Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With At Least One Adverse Event During Treatment Period
Time Frame: From randomization to 30 days after completion of study treatment
The percentage of participants who experienced at least one adverse event during study treatment.
From randomization to 30 days after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.
Innovent Biologics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoSTEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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