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

NCT05843292 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NeoSTEP
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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. 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. 2.Does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term ICIs reported in literature?

Conditions

Triple-negative Breast Cancer

Keywords

Short-term Sintilimab; Taxane; Carboplatin; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR) Rates

  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 Outcomes (3)

• Objective Response Rates (ORR)

  At surgery.

• Event-free survival (EFS)

  From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)

• Overall survival (OS)

  Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)

Other Outcomes (1)

• Percentage of Participants With At Least One Adverse Event During Treatment Period

  From randomization to 30 days after completion of study treatment

Study Arms (1)

Short-term Sintilimab in Combination With Taxane and Carboplatin

EXPERIMENTAL

Prior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin

Drug: Taxane and Carboplatin; Drug: Short-term Sintilimab; Procedure: Surgery

Interventions

Taxane and Carboplatin DRUG

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.

Short-term Sintilimab in Combination With Taxane and Carboplatin

Short-term Sintilimab DRUG

Sintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.

Short-term Sintilimab in Combination With Taxane and Carboplatin

Surgery PROCEDURE

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

Short-term Sintilimab in Combination With Taxane and Carboplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years, female;
• Unilateral, invasive, primary breast cancer, T≥1cm, cN0-3, M0;
• Immunohistochemistry(IHC): ER, PR\<10%; HER-2 IHC "0", OR IHC "+", OR IHC "++" AND fluorescence in situ hybridization (FISH) negative;
• At least one measurable lesion according to RECIST V1.1;
• Newly or recently-collected core needle biopsy specimen of the primary lesion available for PD-L1 status determination;
• ECOG score 0 or 1 within 10 days prior to drug administration;
• Currently not pregnant or breastfeeding, and meet at least one of the following conditions:
• NOT women of childbearing potential (WOCBPs).
• WOCBPs that strictly adopt contraceptive measures during treatment and within at least 6 months after last drug administration.
• Organs well-functioned according to laboratory examination and imaging;
• Having good compliance with treatment plans, being capable of understanding the research process, and having signed a written informed consent.

You may not qualify if:

• Bilateral invasive breast cancer or metastatic (Stage IV) breast cancer;
• With severe cardiovascular conditions:
• Myocardial infarction, acute coronary syndrome or PCI/CABG within 6 months;
• Current NYHA II-IV congestive heart failure (CHF) or past history of NYHA III-IV CHF.
• Immunodeficiency, or undergoing systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to drug administration;
• Active autoimmune diseases requiring systemic treatment within the past 2 years;
• Known history of active tuberculosis caused by Bacillus Tuberculosis;
• History of non infectious pneumonia requiring steroid treatment, or active pneumonia of all types;
• Severe systemic infections, or other serious illnesses;
• History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
• Known history of human immunodeficiency virus (HIV) infection;
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
• Known allergy or intolerance to therapeutic drugs or their excipients;
• History of receiving cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason;
• 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.);

Sponsors & Collaborators

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

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MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

taxane; Carboplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Jiayi Wu

CONTACT

0086-021-64370045; pinkscorpio@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Comprehensive Breast Health Center, Ruijin Hospital

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2034
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share