跳至主要内容
临床试验/NCT06733233
NCT06733233尚未招募2 期

A Multicenter, Prospective Phase II Single-arm Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with T-DXd in Combination with an Immune Checkpoint Inhibitor in HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer

Guangzhou Women and Children's Medical Center0 个研究点目标入组 23 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
23
主要终点
pathologic complete remission

研究概览

简要总结

This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary intermediate- to high-risk HR-positive, HER2-overexpressing early-stage breast cancer.

详细描述

Neoadjuvant therapy, a systemic therapy administered prior to localized treatments such as surgery, has become a key component in the management of non-metastatic breast cancer. Neoadjuvant chemotherapy is often used to treat early-stage, high-risk hormone receptor-positive (HR+) breast cancer; however, the rate of pathological complete remission(pCR) is only 5-8 %. Moreover, neoadjuvant chemotherapy has significant toxicity, with approximately 25-40% of patients discontinuing chemotherapy or reducing their dosage due to side effect.

Much evidence suggests that immune checkpoint inhibitors (ICIs) combined with chemotherapy significantly increase pCR rates in HR+ breast cancer.

The CheckMate 7FL study evaluated the efficacy of ICI (nabulizumab) in early-stage HR-positive breast cancer, and ICI in combination with chemotherapy increased the pCR rate to 24%, compared to 13.8% in the chemotherapy arm[4].

The Keynote756 clinical trial demonstrated for the first time that the addition of an ICI (pembrolizumab) to a neoadjuvant chemotherapy regimen for early-stage, high-risk ER+/HER2- breast cancer significantly increased patients' pCR rates. These clinical trials imply that ICIs in combination with chemotherapy can provide more benefit to patients with early-stage breast cancer compared to traditional neoadjuvant chemotherapy treatments.

Trastuzumab deruxtecan (DS-8201a, T-DXd) is a novel HER2-targeted antibody-drug coupling (ADC) approved by the FDA and NMPA for the treatment of HER2-positive and HER2-low expressing metastatic breast cancer.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adults between the ages of 18 and 70 at the time of signing the informed consent form.
  • An Eastern Cooperative Oncology Group (ECOG) score of 0 to
  • Previously untreated, operable invasive breast cancer measuring greater than 2.0 centimeters (cT2) with positive clinical lymph nodes (cN1/cN2); or clinically staged T3-T4, clinically lymph node-negative (N0) or clinically lymph node-positive (cN1/cN2) without distal metastases.
  • Tumors with low levels of HER2 expression by immunohistochemistry (IHC), defined as IHC 1+ or IHC 2+ and FISH negative.
  • Tumor documented as HR-positive (ER and/or PgR-positive [ER or PgR ≥1%] by local assessment according to ASCO-CAP guidelines).
  • Patients who agree to undergo surgical treatment for breast cancer when they meet surgical criteria after neoadjuvant therapy.

排除标准

  • Stage IV (metastatic) breast cancer and bilateral breast cancer
  • Previous history of invasive breast cancer.
  • Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
  • Other malignant tumors within 5 years, excluding cured carcinoma in situ of the cervix and non-melanoma skin cancers.

研究组 & 干预措施

T-DXd combined with immune checkpoint inhibitor

Experimental

干预措施: T-DXd combined with immune checkpoint inhibitor (Drug)

结局指标

主要结局

pathologic complete remission

时间窗: 3 years

次要结局

  • overall survival(3 years)
  • event free survival(3 years)
  • invasive disease free survival(3 years)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huijin Wang

Director of Thyroid and Breast Disease Center

Guangzhou Women and Children's Medical Center

相似试验