NCT05843292Not yet recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 6 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 48 (estimated)
First submitted: 25 Apr 2023
Start date: 1 Jul 2023
Primary completion date: 31 Dec 2024
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Diseases: Triple-negative breast cancer
NCT number: NCT05843292

What you commit to

Study type: Interventional · Phase 4
Planned participants: 48
From 1 Jul 2023 to the primary completion date, 31 Dec 2024
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Other

During pregnancy or breastfeeding, or WOCABs that refuse to adopt strict contraceptive measures;
Deemed to be not appropriate for participating in this study by researchers.

Who the study is looking for

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.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.