Clinical trial NCT05843292: Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Triple-negative Breast Cancer
Keywords: Short-term Sintilimab
Taxane
Carboplatin
Neoadjuvant Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Innovent Biologics, Inc.
name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2023-05-06
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic Complete Response (pCR) Rates
timeFrame: At surgery.
Secondary outcomes:
measure: Objective Response Rates (ORR)
timeFrame: At surgery.
measure: Event-free survival (EFS)
timeFrame: From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)
measure: Overall survival (OS)
timeFrame: Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)
Other outcomes:
measure: Percentage of Participants With At Least One Adverse Event During Treatment Period
timeFrame: From randomization to 30 days after completion of study treatment
Locations:
Study officials:
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