Efficacy and Safety of Sintilimab and Apatinib Combined Chemotherapy in Breast Cancer

NCT04722718 | Unknown Phase 2

• 1 other identifier: AHQU-2021003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The efficacy and safety of immunotherapy and antiangiotherapy in combination with chemotherapy in neoadjuvant therapy for triple-negative breast cancer (TNBC) were determined by the addition of sintilimab and apatinib to neoadjuvant chemotherapy
2. 2.To clarify the breast-conserving rate, toxicity, difference in pathologic complete response (pCR) rate of patients with PD-L1 (+) and PD-L1 (-) after neoadjuvant treatment of TNBC with immunotherapy and anti-vascular therapy combined with chemotherapy and the relationship between pCR rate of immunomodulated type (IM) and non-immunomodulated type patients in "Fudan classification".
3. 3.Through post-treatment efficacy evaluation and safety analysis, we provide new treatment strategies for TNBC patients, increase the pCR rate of TNBC patients, and ultimately improve the long-term survival of patients.

Conditions

Breast Cancer

Keywords

Breast Cancer;Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Pathological complete response (pCR) rate: using the definition of ypT0/Tis ypN0 ( namely:no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery according to American Joint Committee on Cancer (AJCC) Staging System.

  4-6 months

Secondary Outcomes (10)

• DFS

  2 years

• DCR

  4 months

• Rate of breast conserving surgery

  4 months

• Difference in pCR rate due to the state of PD-L1 expression

  4 months

• The difference of pCR rates among different subtypes in TNBC

  4 months

Study Arms (1)

Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin

EXPERIMENTAL

Drug:Sintilimab;Drug:Apatinib;Drug:Albumin-Bound Paclitaxel(Nab-Paclitaxel);Drug:Carboplatin

Drug: Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin

Interventions

Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin DRUG

Sintilimab:200mg,ivgtt,d1,21days/cycle;Apatinib:250mg po,d1-14days,21days/cycle;Albumin-Bound Paclitaxel(Nab-Paclitaxel):125mg/m2,ivgtt,d1,d8,21days/cycle;Carboplatin:AUC=1.5,ivgtt,d1,d8, 21days/cycle.Monitoring of blood routine, biochemical and urine routine, electrocardiogram, and record the patient's drug-related adverse reactions every cycle,according to the curative effect of patients, compliance and tolerance, neoadjuvant therapy 6 cycles,every 2 cycles to evaluate curative effect (ultrasonic, breast X-ray CT, bone scan, brain, lungs, assessment and breast MRI imaging).

Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+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:

• The Eastern Cooperative Oncology Group (ECOG) scores ranged from 0 to 1 in women aged 18 to 70 years.
• Pathologically confirmed patients with TNBC(negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status), clinical stage II and III (T stage: T1c, N stage: N1-2, or T stage: T2-4, N stage: N0-2),newly treated patients who have not received surgery or chemotherapy.
• According to response evaluation criteria in solid tumors (RECIST) version 1.1, it was confirmed by MRI or CT that at least one measurable lesion was the target lesion and the target lesion was not suitable for surgical treatment. If the target lesion was lymph node, the short diameter was \> 1.5cm.
• Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen.
• Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.
• Adequate hematologic and end-organ function.
• Baseline laboratory tests, such as blood routine, biochemical and electrocardiogram, were normal, without chemotherapy contraindication.
• Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
• Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
• Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment.

You may not qualify if:

• Prior history of invasive breast cancer.
• Prior systemic therapy for treatment and prevention of breast cancer.
• History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy \>5 years prior to diagnosis of current breast cancer.
• History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed \>5 years prior to diagnosis of current breast cancer.
• Bilateral breast cancer.
• Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes.
• Axillary lymph node dissection prior to initiation of neoadjuvant therapy.
• Have uncontrolled clinical symptoms or diseases of the heart, such as:
• (1) heart failure above NYHA 2 (2) unstable angina pectoris (3) myocardial infarction occurred within 1 year (4) supraventricular or ventricular arrhythmia of clinical significance requires treatment or intervention.
• Urine routine test indicates urine protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g.
• Patients with hypertension (systolic blood pressure \> 140mmHg, diastolic blood pressure \>90mmHg) and unsatisfactory drug control.
• Have bleeding tendency, or combined with venous thrombosis to receive anticoagulant therapy, urine protein positive.
• Significant abnormalities of the digestive system, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc., may affect the intake, transport, or absorption of oral drugs.
• Had major surgery within 4 weeks, or had a major traumatic injury, fracture, or poor healing wound.
• Systemic therapy 2 years of active autoimmune disease(such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism, decreased thyroid function; subjects suffering from vitiligo or asthma in childhood has been completely relieved, and adults without any intervention can be included; subjects requiring bronchodilators for medical intervention can not be included), diagnosis of immune deficiency in 1 weeks or the use of immunosuppressive therapy, the history of human immunodeficiency virus (HIV) infection, had glucocorticoid treatment history of non infectious pneumonia, suffering from pneumonia, active tuberculosis, active hepatitis b or hepatitis c virus (HCV) infection, and is being treated for a whole body of any active infection.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (1)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

RECRUITING

Related Publications (1)

• Shen G, Liu Z, Wang M, Zhao Y, Liu X, Hou Y, Ma W, Han J, Zhou X, Ren D, Zhao F, Li Z, Huang S, Chen Y, He Y, Liu Y, Zhu Z, Li Y, Li J, Da M, Mo H, Du F, Cui L, Bai J, Liu Z, Ma F, Zhao J. Neoadjuvant apatinib addition to sintilimab and carboplatin-taxane based chemotherapy in patients with early triple-negative breast cancer: the phase 2 NeoSAC trial. Signal Transduct Target Ther. 2025 Feb 7;10(1):41. doi: 10.1038/s41392-025-02137-7.

  PMID: 39915443 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: April 28, 2022

Record last verified: 2021-05

Locations

CN (1)