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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05843292
Collaborator
Innovent Biologics, Inc. (Other), CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)
48
Enrollment
1
Arm
140
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Taxane and Carboplatin
  • Drug: Short-term Sintilimab
  • Procedure: Surgery
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer, an Open-labeled, Single Arm Trial
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2034

Arms and Interventions

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

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.

Procedure: Surgery
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Outcome Measures

Primary Outcome Measures

  1. Pathologic Complete Response (pCR) Rates [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).

Secondary Outcome Measures

  1. Objective Response Rates (ORR) [At surgery.]

    The percentage of participants with complete response (CR) and partial response (PR) in accordance with RECIST V1.1 definitions.

  2. Event-free survival (EFS) [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.

  3. Overall survival (OS) [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.

Other Outcome Measures

  1. Percentage of Participants With At Least One Adverse Event During Treatment Period [From randomization to 30 days after completion of study treatment]

    The percentage of participants who experienced at least one adverse event during study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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:

  8. NOT women of childbearing potential (WOCBPs).

  9. WOCBPs that strictly adopt contraceptive measures during treatment and within at least 6 months after last drug administration.

  10. Organs well-functioned according to laboratory examination and imaging;

  11. 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:

  3. Myocardial infarction, acute coronary syndrome or PCI/CABG within 6 months;

  4. Current NYHA II-IV congestive heart failure (CHF) or past history of NYHA III-IV CHF.

  5. Immunodeficiency, or undergoing systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to drug administration;

  6. Active autoimmune diseases requiring systemic treatment within the past 2 years;

  7. Known history of active tuberculosis caused by Bacillus Tuberculosis;

  8. History of non infectious pneumonia requiring steroid treatment, or active pneumonia of all types;

  9. Severe systemic infections, or other serious illnesses;

  10. History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;

  11. Known history of human immunodeficiency virus (HIV) infection;

  12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;

  13. Known allergy or intolerance to therapeutic drugs or their excipients;

  14. History of receiving cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason;

  15. 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.);

  16. 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;

  17. 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;

  18. History of mental illness or drug abuse that may affect compliance with trial requirements;

  19. During pregnancy or breastfeeding, or WOCABs that refuse to adopt strict contraceptive measures;

  20. Deemed to be not appropriate for participating in this study by researchers.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine
  • Innovent Biologics, Inc.
  • CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kunwei Shen, Professor, Director of Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT05843292
Other Study ID Numbers:
  • NeoSTEP
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kunwei Shen, Professor, Director of Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Short-term Sintilimab
Taxane
Carboplatin
Neoadjuvant Therapy
Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Carboplatin
Taxane

Study Results

No Results Posted as of May 6, 2023