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Clinical Trials/NCT06733233
NCT06733233Not yet recruitingPhase 2

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 sites23 target enrollmentStarted: January 1, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
23
Primary Endpoint
pathologic complete remission

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

T-DXd combined with immune checkpoint inhibitor

Experimental

Intervention: T-DXd combined with immune checkpoint inhibitor (Drug)

Outcomes

Primary Outcomes

pathologic complete remission

Time Frame: 3 years

Secondary Outcomes

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

Investigators

Sponsor
Guangzhou Women and Children's Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Huijin Wang

Director of Thyroid and Breast Disease Center

Guangzhou Women and Children's Medical Center

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